Obstructive Sleep Apnea Diagnosis and Treatment - part 10 pot

Physician’s Duties to Diagnose and Treat Obstructive Sleep Apnea Upon establishment of the physician-patient relationship, a physician owes his patient the duty of reasonable care presen

clearly reproduced on a video monitor or a compact printer, the sleep specialist’s interpretation of the test can occur anytime and at any place Often the physician’s diagnosis of OSA occurs without the physician examining or even speaking with the patient Questions may arise whether the sleep study patient and the distant reading physician have established a physician-patient relationship for purposes of

a malpractice action.

The trend in recent case law is for courts to imply the existence of a patient relationship among physicians unknown to the patient if the physician affir- matively undertakes to diagnose and/or treat the patient (32) A Texas case,

physician-Dougherty v Gifford (33), is instructive There, the patient’s specialist sent a biopsy to

his contracted pathologist who practiced in the regional medical center in Paris, Texas The pathologist diagnosed cancer and aggressive treatments ensued, only to

be discontinued when the pathologist admitted to having misread the biopsy (34) Like most distant readers of sleep tests, the pathologist in Paris never intended

to create a professional relationship with the patient The pathologist never met the patient, did not review the patient’s records, and only reviewed the specimen provided The pathologist communicated the results to the patient’s treating physi- cian, who retained primary responsibility for the patient’s care (35).

Nonetheless, the court found on these facts that a physician-patient ship was created by the acceptance of the pathology work, the conduction of the tests, the preparation of a lab report, and the acceptance of a fee for the services ren- dered The court stated that there could be no doubt that the diagnostic services

relation-f urnished on behalrelation-f orelation-f the patient constituted the practice orelation-f medicine (36) As stated

by the Tennessee Supreme Court in a similar case:

In light of the increasing complexity of the health care system, in which patients tinely are diagnosed by pathologists or radiologists or other consulting physicians who might not ever see the patient face-to-face, it is simply unrealistic to apply a narrow definition of the physician-patient relationship in determining whether such a relation-ship exists for purposes of a medical malpractice case Based upon the foregoing authorities, we hold that a physician-patient relationship may be implied when a physician affirmatively undertakes to diagnose and/or treat a person, or affirmatively participates in such diagnosis and/or treatment (37)

rou-Telemedicine Aspects of the Physician-Patient Relationship

The free flow of sleep data to physicians who are not only invisible to the patient but also reside in a state different from the patient challenges traditional notions of the physician’s license to practice medicine All states have adopted laws which define the types of activity constituting the practice of medicine within their borders Such laws generally prohibit persons from engaging in the unlicensed practice of medi- cine, and further punish physicians for aiding and assisting others in the unlicensed practice of medicine.

The threshold question is whether the professional interpretation of a sleep study constitutes the practice of medicine Although each state defines the practice

of medicine somewhat differently, the recent trend is for states to include the pretation of diagnostic tests within the practice of medicine definition Colorado’s practice of medicine definition, which specifically includes the interpretation of tests, is representative In full, the Colorado law provides that:

inter-Practice of medicine In Colorado means holding out one’s self to the public within this state as being able to diagnose, treat, prescribe for, palliate, or prevent any human

disease, ailment, pain, injury, deformity, or physical or mental condition, whether by

the use of drugs, surgery, manipulation, electricity, telemedicine, the interpretation of tests, including primary diagnosis of pathology specimens, images, or photographs, or

any physical, mechanical, or other means whatsoever (38) (emphasis added)

At least 14 states have passed legislation specifically restricting the practice of telemedicine across state lines For example, the Missouri statute defines the “prac- tice of medicine across state lines” to mean:

1 The rendering of a written or otherwise documented medical opinion concerning the diagnosis or treatment of a patient within this state by a physician located outside this state as a result of transmission of individual patient data by electronic or other means from within this state to such physician or physician’s agent; or

2 The rendering of treatment to a patient within this state by a physician located outside this state as a result of transmission of individual patient data by electronic or other means from within this state to such physician or physician’s agent, definition (39).

An Oregon law specifically issues a special purpose license to outside cians to practice within Oregon by distant communications, but only after the phy- sician has first personally examined the patient (40) Other states, such as Alabama, issue a three-year special purpose license (41).

physi-If the interpretation of the sleep study constitutes the practice of medicine, the next question is “which licensing authority governs?” The general rule in malprac- tice actions is that the patient’s location at the time of service determines the location where the treatment occurs (42) As stated by the Ninth Circuit Court of Appeals in

Wright v Yackley (43):

In the case of personal services focus must be on the place where the services are rendered, since this is the place of the receiver’s (here the patient’s) need This need is personal and the services rendered are in response to the dimensions of that personal need They are directed to no place but to the needy person herself

Although improper licensure may not, by itself, indicate negligence in all malpractice actions (44), proper licensure can be a condition to the presentation

of a clean, nonfraudulent claim to a government healthcare program for reimbursement (45).

Physician’s Duties to Diagnose and Treat Obstructive Sleep Apnea

Upon establishment of the physician-patient relationship, a physician owes his patient the duty of reasonable care present in the community when treating his patient (31) A 1993 Louisiana case found a hospital and its physicians liable for the death of patient William Cornett as a result of the defendants’ failure to treat the decedent’s OSA (6) Mr Cornett suffered from acromegaly, a generally nonmalig- nant pituitary tumor causing excessive secretion of growth hormones and the result- ing enlargement of facial features, limbs, and soft tissues of the body (46) The condition may cause OSA, from which Mr Cornett also suffered (46).

In March 1986, a family practice resident at the defendant hospital examined

Mr Cornett, who complained of chest pains and sleep apnea The resident referred the patient to the hospital’s endocrinology clinic for acromegaly The hospital failed

to schedule the appointment (46).

Seven months later, Mr Cornett presented at the hospital’s emergency room believing he was in a diabetic coma He again explained his four- to five-year history of sleep apnea, and Mr Cornett fell asleep during his diabetes testing, which proved negative Concerned about Mr Cornett’s somnolence, the emer- gency room physician ordered arterial blood gas testing, which indicated elevated carbon dioxide levels and low oxygen levels The emergency room physician testi- fied at trial that Mr Cornett requested treatment for sleep apnea because he had fallen asleep while driving The doctor diagnosed acromegaly and sleep apnea To confirm the diagnosis of acromegaly, the physician ordered diagnostic tests at the hospital’s endocrinology clinic These tests confirmed the diagnosis of the pituitary condition (47).

Mr Cornett presented at the endocrinology clinic two weeks later when a ferent hospital physician confirmed a diagnosis of acromegaly and central hypoxia This physician ordered pulmonary function testing at the hospital’s chest clinic, but

dif-Mr Cornett died before his scheduled appointment date The cause of death was documented as cardiopulmonary arrest as a consequence of pituitary tumor (47) Expert testimony at trial indicated that Mr Cornett’s death was more likely caused by sleep apnea and, had the hospital and its physicians provided appropriate medical treatment for OSA, Mr Cornett would have survived The last two hospital physicians who examined Mr Cornett acknowledged that OSA is a potentially fatal condition Each also testified that they failed to inform Mr Cornett of the risk of death presented by untreated sleep apnea The hospital’s own medical expert acknowl- edged that sleep apnea may lead to life-threatening cardio-respiratory events and that the disease is a recognized emergency The appellate court affirmed the trial court’s holding the hospital and the physicians liable for professional negligence (48).

Physician’s Duty to Obtain Patient’s Informed Consent for Obstructive

Sleep Apnea Surgery

Physicians have a general duty to provide their patients with sufficient tion concerning their diagnosis, the nature and reason for the proposed treatment, the risks or dangers involved, the prospects for success and alternatives methods

informa-of treatment and the risks and benefits informa-of such treatment (49) An unpublished decision of the Tennessee Court of Appeals discusses a physician’s duty to inform

a sleep apnea patient of CPAP treatment before performing plasty (UPPP) (50).

uvulopalatopharyngo-The case involved a board-certified otolaryngologist who scheduled a gent tonsillectomy for his 49-year-old male patient The patient asked whether the procedure would help his snoring Examining the patient further, the physician diagnosed mild sleep apnea and recommended surgical treatment The patient tes- tified at trial that he heard the doctor say that the doctor would trim his uvula, but the physician’s notes indicated “surgery discussed, risks, and complications, sched- ule tonsillectomy, septoplasty, UVPP (uvulopharyngoplasty)” (51) In fact, the defendant physician performed the UPPP procedure At no time did the physician advise his patient as to any nonsurgical alternatives to remedy his snoring.

nonur-The patient suffered various neurological disorders following the surgery and brought a malpractice action against the physician Plaintiff based his claim on the physician’s failure to inform his patient of noninvasive alternatives and failure to inform him of the diagnosis of OSA so that the patient could be properly informed

of risks that stemmed from that diagnosis In support, Plaintiff’s medical expert testified that the physician should have informed Plaintiff of noninvasive snoring

treatments, such as CPAP and laser surgery The expert further testified that the physician should have ordered a sleep study to determine the presence of sleep apnea and the severity of the condition However, on cross-examination, the expert admitted that even he did not send all of his patients who presented with OSA symptoms for a sleep study and that a sleep study was not required to identify the location in the throat that caused the snoring (52).

The physician presented the medical testimony of two fellow gists These doctors testified that the treating physician informed the patient of the procedure and risks consistent with the standards of the community The jury also considered the broad language of the written consent form signed by the patient

otolaryngolo-On the basis of the expert testimony and the patient’s written consent, the jury determined that the physician properly informed his patient and found for the physician (53).

What is unknown is a physician’s responsibility to recognize the documented link between sleep apnea and hypertension, cardiovascular disease, and other dis-

eases (3) when performing routine examinations The Cornett case discussed above

indicates the risks attendant to physicians who fail to recognize the urgency of the disease Increased awareness of sleep medicine and recognition by the American Board of Medical Specialties of sleep medicine as a subspecialty (54) may bring minimum sleep inquiries into the community standard of practice for cardiologists, pulmonologists or family practice physicians whose patients present with typical OSA markers.

Physician’s Duties and Liabilities to Third Parties for the Acts of Their

Obstructive Sleep Apnea Patients

Duty to Warn and Report Impaired Driving

Because hypersomnolence generally follows untreated OSA, a physician may have additional legal and ethical duties to the public to inform the patient of the risks of fatigued driving caused by the failure or refusal to treat the disease In appropriate cases, the physician may be required by law to report the patient’s condition to applicable state motor vehicle agencies.

Although no case found expressly discusses a physician’s duty to third parties

in the context of an OSA patient, under the proper facts, a physician owes a duty to use reasonable care to protect the driving public if the physician’s negligence in diagnosis or treatment of his patient contributes to Plaintiff’s injuries (55).

One principal case holds that a physician who “takes charge” of a patient whom the physician knew or should have known was likely to cause bodily harm

to others adopts the duty of reasonable care to prevent the patient from causing harm to others (56) However, courts readily distinguish a physician’s prescribing narcotic drugs or similar treatment plans from situations in which the physician

“takes charge” of the patient The courts reason “that whether the patient takes the medication and then drives is beyond the doctor’s control In fact, whether the patient consumes the medication at all is beyond the doctor’s control” (57) This same result would logically follow upon an injury caused by an OSA patient’s failure to comply with his or her CPAP treatment.

However, the law requires a physician to warn the patient of the risks flowing

from the use or misuse of the treatment (58) In Gooden v Tips (59), a physician

prescribed Quaalude tablets for his patient but failed to warn her not to drive under its influence The patient’s drug-induced driving injured third parties, who brought

suit against the physician The court ruled that the physician was liable to the injured third parties not because the physician had a duty to prevent his patient from driving, but because the physician had the duty to warn the patient not to drive, which he failed to do (30) A treating physician may have a similar duty to warn an OSA patient that the disease may cause a risk of drowsy driving if left untreated or treated improperly.

In addition to legal duties under common law negligence, physicians may have

a statutory obligation to report impaired driving to the department of motor vehicles For example, Vermont, Oregon, New Jersey, California, Delaware, Pennsylvania, and Nevada require physicians to report specific disorders of their patients to appropriate state agencies, typically the state department of motor vehicles (60) Other states permit physicians to report their patients’ impaired driving conditions, but do not require reporting Still other state laws permit the report to be made anonymously, while some laws offer physicians complete immunity from liability if they have reported the patient’s condition to the applicable agency prior to a patient’s injury (61).

According to the American Medical Association’s “Physician’s Guide to Assessing and Counseling Older Drivers,” patients with a diagnosis of narcolepsy should cease driving altogether (62) The Guide suggests that patients with sleep apnea may drive if they do not suffer excessive daytime drowsiness as a conse- quence of therapy or otherwise (63) Physicians in reporting states should check with the department of motor vehicles in their states to determine if a sleep disorder

is a specified condition for which reporting is required.

Even if reporting is not required, physicians face legal and ethical dilemmas if they judge the patient unfit to drive but the patient refuses to comply In 2000, the American Medical Association adopted Ethical Opinion E-2.24 to address physicians’ ethical obligations in this regard (63) According to the Opinion, if clear evidence of substantial driving impairment implies a “strong threat” to patient and public safety, and if the patient ignores the advice to discontinue driving, then the AMA believes it

is desirable and ethical for the physician to notify the applicable department of motor vehicles However, the Opinion clarifies that the physician must follow state law if reporting is required The Opinion also advises that physicians should disclose and explain their responsibility to report to their patients.

Reporting a patient’s impaired driving condition impacts an array of legal issues, including patient confidentiality If a state law requires or permits disclosure, patient authorization may be required prior to the disclosure The Privacy Standards applicable to protected health information under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) will not stand in the way if state law requires or permits disclosure without authorization HIPAA permits healthcare providers to disclose protected health information without individual authorization

as “required by law” (64) or to avert a serious threat to health or safety (65) However, HIPAAs provisions yield to more stringent state laws Accordingly, prior patient authorization may still be required under state law even though HIPAA may permit

an unauthorized disclosure.

LEGAL OBLIGATIONS OF PERSONS EMPLOYING OBSTRUCTIVE

SLEEP APNEA PATIENTS

Because science and the law recognize OSA as an impairment which, if untreated, may adversely affect work performance and safety, the law imposes distinct legal duties on employers of OSA patients These duties include taking reasonable

accommodations to the extent required by federal and state disability laws, vicarious liability for the acts of drowsy employees, and, in certain industries, the adoption of fitness for duty standards that recognize the risks posed by employees with sleep apnea.

Disability Laws

The Americans with Disabilities Act (ADA) (66), along with the Rehabilitation Act

of 1973 (67) and similar state civil rights laws (68), prohibits discrimination by certain employers against qualified individuals with a disability (69) A “qualified individual” is one who is capable of performing the essential function of a job with

or without reasonable accommodations (70) For example, if driving is an essential function of one’s job and if an employee cannot safely drive due to his combined conditions of severe OSA, narcolepsy and cataplexy, then the employee is not a

“qualified individual” eligible for ADA protections (71) The same holds true if sleep apnea prevents an employee from working overtime in his job as a power company lineman when working overtime shifts is an essential function of being a lineman (72) If the employee is not a qualified individual, then the employer has no obliga- tion under the ADA to make the employee’s job easier or even to make the job available at all (73).

Qualified individuals have often claimed OSA is an ADA disability and that such persons therefore deserve redress for lost employee benefits, promotions or even their jobs due to their disability However, the allegation of a particular diag- nosis, standing alone, is insufficient to establish a disability under the ADA (74) The answer whether OSA is an ADA disability requires an individualized, case-by-case approach to evaluate whether the employee’s impairment is severe enough to constitute a disability for ADA purposes (75) Thus, the proper legal inquiry in such matters is not whether sleep apnea is a disability for purposes of ADAs protections, but whether the individual’s sleep apnea substantially limits his or her major life activities as those terms are defined by the ADA.1

To establish a prima facie case of discrimination under the ADA, the employee must show that: (i) he is disabled within the meaning of the ADA, (ii) he is qualified

to perform the essential functions of his job either with or without reasonable

accom-modation, and (iii) he has suffered from an adverse employment decision because

of his disability (76).

To prove the existence of a disability, the employee must show that (i) he fers from an impairment; (ii) the impairment affects major life activities; and (iii) the

suf-impairment “substantially limits” such major life activities (77).

Although the ADA does not define “impairment,” regulations promulgated under the ADA by the Employee Equal Opportunities Commission do (78) These regulations define a physical or mental impairment to include, in part, any physio- logical disorder or condition affecting a person’s neurological, musculoskeletal, respiratory or cardiovascular systems (79).

1Under certain circumstances sleep apnea is considered a disability for some federal benefit programs, such as Veteran’s Affairs, 38 CFR § 4.97 Persons seeking social security disability benefits must prove that they have a “disability,” which is defined to mean the “inability to engage in any substantial gainful activity” due to a “physical or mental impairment” that could cause death or might reasonably be expected to last continuously for at least twelve

months See 42 U.S.C § 423(d) (1) (A).

Courts discussing OSA in the context of these ADA regulations routinely find—and employers routinely concede—that OSA is a physical impairment in satisfaction of the first prong of the analysis (80) Sleep apnea affects one’s ability to breathe during sleep As a consequence, one may not achieve a sound sleep at night and may drop off to sleep uncontrollably during the work day This condition could reasonably be considered a respiratory disorder within the definition of “physical impairment” (81).

The second prong of the test requires that the impairment affect a major life activity The regulations make clear that “breathing” is included in the definition of a

“major life activity” for purposes of meeting the ADA test (78) “Sleeping,” however,

is conspicuously absent from the regulatory list of major life activities ADA claimants with OSA can finesse the point by claiming that their sleep apnea substantially limits their breathing during sleep, thus impacting both activities (82).

In fact, most courts interpret ADA regulations to find that “sleeping” is a major life activity for ADA purposes (83) “Sleeping is a basic activity that the average person in the general population can perform with little or no difficulty, similar to the major life activities” that do appear in the regulations: walking, seeing, hearing, speaking, breathing, learning, and working (84) Interestingly, courts have also ruled that staying awake, in and of itself, is not a major life activ- ity (85), and that general sleeplessness is insufficient to show a significant impairment to one’s activity of sleeping (86).

Having determined that sleep apnea is an “impairment” affecting a “major life activity,” the determination whether sleep apnea is a disability under the ADA depends, in each case, whether the claimant can prove that sleep apnea substan- tially limits the claimant’s sleep or breathing for purposes of ADA protection Such

proof must satisfy yet another three part evaluation relative to (i) the nature and severity of the impairment; (ii) the duration or expected duration of the impairment; and (iii) the permanent long-term impact, or the expected permanent or long-term

impact of or resulting from the impairment (87) In addition, courts will consider the measures used by the claimant to mitigate or treat his condition (86), such as, in the case of sleep apnea, CPAP (82).

The courts recognize that a determination of ADA disability for persons with OSA depends on the severity of the impairment, which presents in a wide spectrum:

In general terms sleep apnea can be so severe such that it does impact on the major life activity of sleep [Citation omitted] Sleep apnea, however, is also a condition that varies

in severity from very mild asymptomatic snoring to severe snoring and extremely restless sleep with extreme daytime hypersomnolence or excessive sleepiness during the day (88)

The use of CPAP therapy to correct or mitigate OSA symptoms is a key factor

in determining the severity of the employee’s disease in the determination of ADA disability Thus, in a situation where common OSA therapies such as CPAP and sur- gery failed to alleviate an employee’s fatigue resulting from severe sleep apnea, the United States District Court of Eastern Pennsylvania permitted the jury to consider whether the employee’s OSA constituted a severe impairment for ADA disability purposes (89).

Cases involving successful use of CPAP reach different conclusions (90) The case of an obese police officer, 46-year-old Ike Mont-Ros, is instructive (82) Officer Mont-Ros was diagnosed with sleep apnea in 1993 His employer paid for his CPAP

machine to alleviate his symptoms and, when Officer Mont-Ros’ knees became too brittle for regular police work, accommodated Mont-Ros’ request for light-duty, daytime dispatch duties Armed with a physician’s opinion that Officer Mont-Ros was not qualified to perform police work due to his orthopedic problems, the police department fired Officer Mont-Ros on grounds that he was hired originally to per- form police duties at police officer pay, not civilian dispatch duties compensated at lower rates Mont-Ros sued the City of West Miami for intentional discrimination against him due to his sleep apnea disability.

Using the applicable three-part tests, the court held that Officer Mont-Ros failed to provide sufficient evidence to support his contention that his sleep apnea constituted a disability under the ADA While expert testimony showed that OSA is

a severe, potentially life-threatening disease, Mont-Ros failed to show the severity

of the disease in his specific case Finally, the court noted that because OSA is able and can be corrected with the use of CPAP at night, Officer Mont-Ros could not demonstrate that he is substantially limited in any major life activity As Officer Mont-Ros’ own medical expert point out, “much like the use of glasses to correct ones vision, the use of the nasal CPAP machine at night will alleviate Plaintiff’s condition during sleeping hours and, thus, reduce the daytime drowsiness (91).” Thus, in the worker’s compensation context, OSA patients using CPAP earn no impairment ratings because “treated OSA has no permanent disability” (92).

treat-Employers’ Liability for Employee’s Negligence

The application of traditional vicarious liability rules renders employers vicariously liable for the acts of their employees when performed in the scope of their employ- ment (93) Thus, when Norman Munnal killed a woman when he fell asleep at the wheel of a tractor-trailer while driving for his trucking company employer, it was W.L Logan Trucking Company that faced liability for its driver’s acts (94) The trucking company invoked Ohio’s version of the “sudden blackout” doctrine to defend Munnal’s conduct (95) The employer alleged that it was the driver’s “sudden unconsciousness” that caused the truck to move left of center, and that Munnal cannot be liable for losing control under these circumstances (95).

As we have seen, the sudden blackout defense fails if defendant knew that consciousness loss was likely to occur or was otherwise foreseeable (95) Munnal testified that he had a propensity to fall asleep at unpredictable times and that he had fallen asleep at the wheel at least once before (96) A sleep test ordered after the accident revealed that he suffered from severe OSA (96) At trial, Munnal’s sleep disorders specialist opined that many sleep apnea patients engage in automatic behavior, such as driving, while unknowingly unconscious (97) The expert distin- guished automatic behavior from fainting following a sudden blackout, and opined that distance truck driving was not the right profession for someone with untreated sleep apnea (96).

Even though Munnal testified that he had no knowledge of his sleep apnea before the accident (96), the court ruled that the employee driver was aware of his excessive fatigue and propensity to falling asleep at inopportune times (98) Because

of this prior knowledge, the court held Munnal negligent for failing to operate the truck in a safe manner, and further found Munnal’s employer trucking company liable for the driver’s acts while in the scope of his employment (98) Under the rule

in this case, employers’ risk management programs would likely benefit from an

employee OSA screening and therapy compliance program for employees working

at safety-sensitive tasks such as driving.

Employers are also exposed to allegations of direct liability if they negligently hire persons with OSA and entrust vehicles to them To prevail on these direct liabil- ity allegations, the injured party must prove that the employee’s fatigue was due to the disease, was known to the employer, and proximately caused the accident leading to damages (99).

Growing awareness of general sleep health and expressions of public policy against drowsy driving of the kind codified in New Jersey by Maggie’s law and New York’s Bell Regulations (limiting medical residents’ work hours) (100) sets the stage for actions against employers brought by unknown third parties injured by overworked, and likely fatigued, employees.

The legal question in such circumstances is whether the employer owes a duty

to control the off-duty conduct of its employee Although the general rule is that employers owe no duty to third parties for the off-duty acts of their employees, (101) at least one court has re-fashioned tort principles to find an employer liable for accidents caused by employees presumably fatigued due to over-scheduling by their employer (102) The same result obtains on similar facts under workmen’s compensation law (103).

Regulatory Screening for Obstructive Sleep Apnea in

Safety-Sensitive Positions

Because sleep apnea is a relatively common medical condition which, if untreated, contributes to daytime sleepiness and impaired job performance (2), public policy suggests that certain industries directly affecting public safety screen employees in safety-sensitive positions for sleep apnea or other fatigue-enhancing sleep disor- ders Thus, each of the air, rail, ferry, distance trucking, and nuclear power indus- tries have or propose regulatory fitness for duty programs addressing OSA.

The National Transportation Safety Board (NTSB) has issued three investigation reports finding that the undiagnosed or untreated OSA of a train or ship operator contributed to the subject incident (104) The latest, in 2004, involved a 2001 collision

of two trains arising from the crewmembers’ fatigue caused primarily by the neer’s untreated and the conductor’s insufficiently treated OSA (105) The 2004 NTSB Report recommended that the Federal Railroad Administration (FRA) take remedial steps regarding employee fatigue (106), and the FRA issued its Safety Advisory 2004-04 on September 21, 2004 in response The Advisory suggests that railroads adopt procedures to recognize sleep disorders, screen employees, and permit impaired persons to perform safety-sensitive tasks only after proper treatment (107).

engi-Federal regulations require that only physically fit persons are eligible to ate a commercial motor vehicle in interstate commerce (108) Persons are considered physically fit if they obtain medical certification from a physician certifying that the applicant does not have an established medical history or clinical diagnosis of, among other ailments, a respiratory dysfunction or other condition which is likely

oper-to cause loss of consciousness or any other loss of ability oper-to control a commercial motor vehicle safely (109) The current Medical Examination Form, updated in 2000, makes specific inquiry whether the applicant suffers from “sleep disorders, pauses

in breathing while asleep, daytime sleepiness, (or) loud snoring (110).”

In 1991, the Federal Motor Carrier Safety Administration published advisory criteria to assist medical examiners determine a driver’s physical qualifications for

commercial driving The guidance regarding pulmonary/respiratory disorders identifies OSA as a condition which, if untreated, renders applicants unqualified to operate a commercial vehicle:

Individuals with suspected or untreated sleep apnea (symptoms of snoring and somnolence) should be considered medically unqualified to operate a commercial vehicle until the diagnosis has been dispelled or the condition has been treated success-fully In addition, as a condition of continuing qualification, commercial drivers who are being treated for sleep apnea should agree to continue uninterrupted therapy as long as they maintain their commercial driver’s license They should also undergo yearly multiple sleep latency testing (MSLT) (111)

hyper-Guidance respecting seizures, epilepsy and interstate commercial driving reaches a similar conclusion as to chronic sleep apnea:

Patients with sleep apnea syndrome having symptoms of excessive daytime lence cannot take part in interstate driving, because they likely will be involved in haz-ardous driving and accidents resulting from sleepiness Even if these patients do not have the sleep attacks, they suffer from daytime fatigue and tiredness These symptoms will be compounded by the natural fatigue and monotony associated with the long hours of driving, thus causing increased vulnerability to accidents Therefore, those patients who are not on any treatment and are suffering from symptoms related to EDS should not be allowed to participate in interstate driving Those patients with sleep apnea syndrome whose symptoms (e.g., EDS, fatigue, etc.) can be controlled by surgical treatment, for example, permanent tracheostomy, may be permitted to drive after three-month period free of symptoms, provided there is constant medical supervision Laboratory studies (e.g., polysomnographic and MSLTs) must be performed to docu-ment absence of EDS and sleep apnea (112)

somno-As to pilots, the Federal Aviation Administration Guide for Aviation Medical Examiners provides that any degree of sleep apnea is disqualifying for medical cer- tification for all classes of pilots (113) However, aviation medical examiners may reissue a pilot’s medical certificate without administrative appeal if the pilot pres- ents a current report of a treating physician that the pilot’s OSA treatment therapy has eliminated symptoms of the disease along with specific comments regarding the pilot’s daytime sleepiness (114).

In 1989, the Nuclear Regulatory Commission (NRC) adopted its first Fitness for Duty Program focusing on detection of drug and alcohol impairments on per- sonnel with access to protected areas of nuclear power reactors licensed by the NRC (115) Congressmen and others petitioned the NRC to expand the regulations to expand the program to include screening for sleep apnea and other disorders The NRC published proposed rules to that effect in August 2005 (116).

LAWS REGULATING DIAGNOSTIC TESTING AND TREATMENT

OF OBSTRUCTIVE SLEEP APNEA

State Certificate of Need and Licensure Laws

The majority of states allocate healthcare resources within their borders through the Certificate of Need (CON) process Most CON laws require healthcare facilities, such as hospitals, magnetic resonance imaging centers and other outpatient diag- nostic centers, to apply for and receive a CON prior to obtaining a state license or otherwise operating Penalties for operating a healthcare facility without a CON range from civil fines to criminal penalties.

CON laws routinely exempt a variety of healthcare activities from the lengthy and expensive CON process These exemptions include the individual or group

practice of physicians and, in many cases, facilities requiring equipment or capital expenditures below a certain dollar threshold A review of applicable CON laws is necessary to determine the impact on sleep testing.

States will typically require healthcare facilities such as nursing homes, latory surgical centers, and some outpatient diagnostic testing facilities to obtain a license prior to operating Because polysomnograms have historically been catego- rized for reimbursement and other purposes as an extensive electroencephalographic (EEG)–electrocardiographic (EKG) modality, states do not usually require separate facility licenses for sleep testing However, a license may be required for freestanding sleep testing facilities Again, review of applicable state laws will be necessary.

ambu-Self-Referral Laws

Providers of healthcare must comply with applicable fraud and abuse laws The risk most relevant to OSA is the so-called federal “Stark” law prohibition on patient self- referrals and related state laws (117) The Stark law prohibits a physician from making

a referral for a designated health service to an entity in which the physician (or an immediate family member of such physician) has a financial relationship—including

a compensation arrangement—if the service is reimbursed by a federal healthcare program (including Medicaid) Only referrals for designated health services are pro- hibited Professional readings for pulmonary function testing, EKGs and EEGs are not designated health services, unless furnished in a hospital setting (118) For this reason, polysomnography is also not considered to be a designated health service However, items of durable medical equipment, including CPAP and bilevel pressure and related supplies, are designated healthcare services under the Stark law (119) Consequently, a physician may not refer anyone to an entity owned, directly or indi- rectly, by the physician or his immediate family, for CPAP if the entity seeks reim- bursement from a federal healthcare program for the CPAP.

Many states have their own laws restricting self-referrals Many are modeled after the federal Stark law and prohibit referrals for durable medical equipment regardless of government reimbursement Some are more restrictive, others are less

A review of the law applicable to the states in which the physician practices is sary to determine compliance.

4 Campos-Rodriguez F, Peña-Griñan N, Reyes-Nuñez N, et al Mortality in obstructive sleep apnea–hypopnea patients treated with positive airway pressure Chest 2005; 128(2):624-633

5 See, e.g., McCall v Wilder, 913 S.W.2d 150 (Tenn 1995).

6 Cornett v State, W.O Moss Hospital, 614 So.2d 189 (La App 3rd Cir 1993)

7 Guilleminault C, Eldridge FL, Dement WC Insomnia with sleep apnea: A new drome, Science 1973; 181(102):856–858

syn-8 Parks v Harris, 614 F.2d 83 (5th Cir 1980)

9 Sullivan CE, Issa FG, Berthon-Jones M, Eves L Reversal of obstructive sleep apnea by continuous positive airway pressure applied through the nares Lancet 1981; 1(8225):862–865

10 Results of a March 10, 2006, Westlaw inquiry of all reported and unreported cases for the mention of “sleep apnea” in any context in any state or federal court.

11 See, e.g., Besaraba v State, 656 So.2d 441 (Fla 1995), Edwards v Edwards, 140 Or App

409 (1996)

12 William L Prosser, Law of Torts, 4th ed, St Paul: West Publishing Co., 1980:143

13 William L Prosser, Law of Torts, 4th ed, St Paul: West Publishing Co., 1980:324

14 See, e.g., Cruzan v Missouri Department of Health, 497 U.S 261, 110 S.Ct 2841, 111 L.Ed.2d 224 (1990)

15 Eric L Schulman, Note, Sleeping with the Enemy: Combatting (sic) the Sexual Spread

of HIV-AIDS Through A Heightened Legal Duty, 29 J MARSHALL L REV 957, 971–

976, 1996

16 American Law Reports 3d, Liability for Automobile Accident Allegedly Caused by Driver’s Blackout, Sudden Unconsciousness, or the Like, Section 2(a), 93 A.L.R 326 (1979), (updated 2006)

17 American Law Reports 2d, Physical Defect, Illness, Drowsiness, or Falling Asleep of Motor Vehicle Operator as Affecting Liability for Injury, Section 3, 28 A.L.R.2d 12 (1953), (updated 2006)

18 Bushnell v Bushnell, 103 Conn 583, 131 A 432 (1925)

19 Bushnell v Bushnell, 103 Conn 583, 591, 131 A 432 (1925)

20 See, e.g., Estate of Embry v GEO Transportation of Indiana, Inc., 395 F Supp 2d 516

(E.D Ky 2005), McCall v Wilder, 913 S.W.2d 150 (Tenn 1995).

21 McCall v Wilder, 913 S.W.2d 150, 155 (Tenn 1995).

22 See, Malcolm v Patrick, 147 So.2d 188 (Fla.Ct.App 1962); accord Eleason v Western Cas & Sur Co., 254 Wis 134, 35 N.W.2d 301 (1948)

23 Howle v PYA/Monarch, Inc., 288 S.C App 586, 344 S.E 2d 157 (1986)

24 Testimony of Darrell Drobnich before the House Subcommittee on Highways and Transit, Committee on Transportation and Infrastructure, 4, June 27, 2002, http://www.house.gov/transportation/highway/06-27-02/drobnich.html, (accessed March 2006)

25 Chapter 143, 2003 New Jersey Public Laws

26 “Maggie’s Law,” N.J.S.2C:11-5(a)

27 See, e.g., Robinson v Bleicher, 251 Neb 752, 559 N.W.2d 473 (1997)

28 See, e.g., Gooden v Tips, 651 S.W.2d 364 (Tex App 1983) (as to physician’s failure to warn a patient not to drive while under the influence of a prescribed drug)

29 See, e.g., U.S Department of Transportation, National Highway Traffic Safety Administration, “Strategies for Medical Advisory Boards and Licensing Review,” DOT

HS 809 874 (July 2005), available at http://www.nhtsa.dot.gov/people/injury/research/MedicalAdvisory/index.html, (accessed March 2006)

30 See, e.g., Gooden v Tips, 651 S.W.2d 364 (Tex App 1983)

31 Kelly v Middle Tennessee Emergency Physicians, P.C., 133 S.W.3d 587, 592 (Tenn 2004)

32 Kelly v Middle Tennessee Emergency Physicians, P.C., 133 S.W.3d 587, 593 (Tenn 2004)

33 Dougherty v Gifford, 826 S.W.2d 668 (Tex App 1992)

34 Dougherty v Gifford, 826 S.W.2d 668, 672 (Tex App 1992)

35 Dougherty v Gifford, 826 S.W.2d 668, 674 (Tex App 1992)

36 Dougherty v Gifford, 826 S.W.2d 668, 674, 675 (Tex App 1992)

37 Kelly v Middle Tennessee Emergency Physicians, P.C., 133 S.W.3d at 596 (Tenn 2004)

38 CRS § 12-36-106(1) (a)

39 Missouri Revised Statutes Section 334.010

40 ORS § 847.025.0010

41 Ala Code § 34-24-502.

42 Wright v Yackley, 459 F.2d 287 (9th Cir 1972)

43 Wright v Yackley, 459 F.2d 287, 289 (9th Cir 1972)

44 Andrews v Lofton, 57 S.E.2d 338, 342 (Ga App 1950); Irwin v Arrendale, 159 S.E.2d

719, 725 (Ga App 1967)

45 See, e.g., 42 CFR 410.33(e) (requiring the supervising physician of an independent nostic testing facility to be licensed in each state in which the facility operates); 31 U.S.C § 3729

diag-46 Cornett v State, W.O Moss Hospital, 614 So.2d 189, 193 (La App 3rd Cir 1993).

47 Cornett v State, W.O Moss Hospital, 614 So.2d 189, 194 (La App 3rd Cir 1993)

48 Cornett v State, W.O Moss Hospital, 614 So.2d 189,196 (La App 3rd Cir 1993)

49 See, e.g Shadrick v Coker, 963 S.W.2d 726, 732 (Tenn 1998)

50 Russell v Brown, No E2004-01855-COA-R3-CV, 2005 WL 1991609 (Tenn.Ct.App.) (August 18, 2005)

51 Russell v Brown, No E2004-01855-COA-R3-CV, 2005 WL 1991609 *2 (Tenn.Ct.App.) (August 18, 2005)

52 Russell v Brown, No E2004-01855-COA-R3-CV, 2005 WL 1991609 *5 (Tenn.Ct.App.) (August 18, 2005)

53 Russell v Brown, No E2004-01855-COA-R3-CV, 2005 WL 1991609 *13 (Tenn.Ct.App.) (August 18, 2005)

54 See, The American Board of Medical Specialties, 2005 Annual Report & Reference Handbook, available at http://www.abms.org/Downloads/Publications/AnnualReport2005.pdf, (accessed March 2006)

55 See, e.g., Wharton Transport Corp v Bridges, 606 S.W.2d 521 (Tenn 1980); Gooden v Tips, 651 S.W.2d 364, 396 (Tex App Tyler 1983)

56 Tarasoff v Regents of University of California, 17 Cal 3d 425, 131 Cal Rptr 14, 551 P.2d

334 (1976)

57 Taylor v Smith, 892 So.2d 887, 895 (Ala 2004)

58 See, e.g., McKenzie v Hawa’i Permanente Med Group, Inc., 98 Hawai’i 296, 309, 47 P.3d 1209, 1222 (2002) (physician “owes a duty to non-patient third parties” to warn patients of possible adverse effects of prescribed medication on patients’ driving abil-ity, “where the circumstances are such that the reasonable patient could not have been expected to be aware of the risk without the physician’s warning”); Joy v Eastern Maine Med Ctr., 529 A.2d 1364 (Me 1987) (physician who treated a patient by placing

a patch over his eye owed a duty to motorists to warn the patient against driving while wearing the patch); Welke v Kuzilla, 144 Mich.App 245, 252, 375 N.W.2d 403, 406 (1985) (physician who injected a patient with an “unknown substance” owed a duty to motorists “within the scope of foreseeable risk, by virtue of his special relationship with [the patient]”); Wilschinsky v Medina, 108 N.M 511, 515, 775 P.2d 713, 717 (1989) (phy-sicians owe a duty “to persons injured by patients driving automobiles from a doctor’s office when the patient has just been injected with drugs known to affect judgment and driving ability”); Zavalas v State Dep’t of Corr.,124 Ore.App 166, 171, 861 P.2d 1026,

1028 (1993) (rejecting the argument “that a physician has no duty to third parties… who claim that the physician’s negligent treatment of a patient was the foreseeable cause of their harm”) But see Kirk v Michael Reese Hosp & Med Ctr., 117 Ill.2d 507, 513 N.E.2d 387, 111 Ill.Dec 944 (1987); Rebollal v Payne, 145 A.D.2d 617, 536 N.Y.S.2d

147 (1988)

59 Gooden v Tips, 651 S.W.2d 364, 370 (Tex App Tyler 1983)

60 See, generally, Massachusetts Medical Society, “Medical Perspectives on Impaired Driving” (July, 2003), available at http://www.massmed.org/AM/Template.cfm?Section=Home&CONTENTID=5027&TEMPLATE=/CM/HTMLDisplay.cfm, (accessed March 2006)

61 American Medical Association, “Physician’s Guide to Assessing and Counseling Older Drivers,” Chapter 8 (May 2003), providing a list of all 51 state laws regarding reporting

of impaired drivers The Guide is available at the American Medical Society Website, http://www.ama-assn.org/ama/pub/category/10791.html, (accessed March 2006)

62 See, American Medical Association, “Physician’s Guide to Assessing and Counseling Older Drivers,” Chapter 8 (May 2003)

63 See, American Medical Society, Ethics Opinion E-2.24, “Impaired Drivers and Their Physicians,” (June 2004), available at http:// www.ama-assn.org (accessed March 2006)

64 See, 42 C.F.R § 164.512(a)

65 See, 42 C.F R § 164.512(j)

66 42 U.S.C §1201, et seq

67 29 U.S.C § 791, et seq

68 See, e.g., Minnesota Human Rights Act, Minn.Stat § 363.01, Wisconsin Fair Employment

Act, Wisc Stats § 111.34, Maine Human Rights Act, 5 M.R.S.A §§ 4551–4634

69 See, e.g., Sutton V United Air Lines, Inc., 527 U.S 471, 477, 119 S.Ct 2139 (1999).

70 See, e.g., EEOC v Amego, Inc., 110 F.3d 135, 144 (1st Cir 1997)

71 Matewski v Orkin Exterminating Co., 2003 WL 21516577 *12 (D Maine, July 1, 2003)

72 Sanders v Firstenergy Corp., 157 Ohio App 3d 826, 834 (2004)

73 Calef v Gillette Co., 322 F.2d 75, 86 (1st Cir 2003)

74 Tice v Centre Area Transportation Authority, 247 F.3d 506, 513 (3rd Cir 2001)

75 Albertson’s, Inc v Kirkingburg, 527 U.S 555, 566 (1999)

76 Dvorak v Mostardi Platt Assoc., Inc., 289 F.3d 479, 483 (7th Cir 2002); Bekker v Humana Health Plan, Inc., 229 F3d 662, 669-70 (7th Cir 2000)

77 Bragdon v Abbott, 524 U.S 624, 631 (1998)

78 29 CFR § 1630.02(h)

79 29 CFR § 1630.02(h)(1)

80 See, e.g., Kolecyck-Yap v MCI Worldcom, Inc., No 99 CV 8414, 2001 WL 245531 (N.D Ill 2001), Peter v Lincoln Technical Institute, Inc., 255 F Supp 417 431 (N.D Ill 2002)

81 Miller v Centennial State Bank, 472 N.W.2d 349, 351 (Minn Ct App 1991)

82 Mont-Ros v City of West Miami, 111 F Supp.2d 1338 (S.D Fla 2000)

83 See, Pack v Kmart Corp., 166 F.3d 1300, 1305 (10th Cir 1999); McAlindin v County of San Diego, 192 F.3d 1226, 1234 (9th Cir 1999), Bennett v Unisys Corporation, No 2:99CV0446, 2000 WL 33126583, at *5 (E.D.Pa Dec.11, 2000); Reese v American Food Service, No CIV A.99-1741, 2000 WL 1470212, at *6 (E.D.Pa Sept.29, 2000), Tedeschi v Sysco Foods of Philadelphia, No CIV A.99-3170, 2000 WL 1281266, at *5 (E.D.Pa Sept.5, 2000); Enforcement Guidance on the Americans with Disabilities Act and Psychiatric Disabilities, Compliance Manual, COMPLIANCE MANUAL (CCH) P6906,

at 5398 (1998) (“EEOC Compliance Manual”) But See, Sarko v Penn-Del Directory Co.,

968 F Supp 1026, 1034 n 8 (E.D Pa 1997) (the ability to get a sound night’s sleep and report to work on time and clear-minded was not a major life activity)

84 Sutton v United Air Lines, 130 F.3d 893, 900 (10th Cir 1997)

85 See Reberg, 2005 WL 3320780 at *5 (citing Katekovich v TeamRent A Car of Pittsburgh, Inc., 36 Fed Appx 688 (3rd Cir.2002); Green v Pace Suburban Bus, No 02 C 3031, 2004

WL 1574246 (N.D Ill July 12, 2004))

86 Pack v Kmart Corp., 166 F.3d 1300, 1306 (10th Cir 1999)

87 29 C.F.R § 1630.2(j)(2)

88 Mont-Ros v City of West Miami, 111 F Supp.2d 1338, 1355 (S.D Fla 2000)

89 Peter v Lincoln Technical Institute, Inc., 255 F Supp 417, 434 (E.D Pa 2002) (ADA claim denied on other grounds)

90 See, e.g., Taylor v Blue Cross Blue Shield of Texas, 1999 WL 451339 *4 (N.D Tex 1999), Pack v Kmart Corp., 166 F.3d 1300, 1306 (10th Cir 1999); Mont-Ros v City of West Miami, 111 F Supp.2d 1338 (S.D Fla 2000); Kolecyck-Yap v MCI Worldcom, Inc., No

99 CV 8414, 2001 WL 245531 (N.D Ill 2001); Wendt v Village of Evergreen Park, No

00 C 7730, 2003 WL 223443 (N.D Ill 2003)

91 Mont-Ros v City of West Miami, 111 F Supp.2d 1338, 1346 (S.D Fla 2000)

92 Long v Mid-Tennessee Ford Truck Sales, 160 S.W.3d 504, 509 (Tenn 2005)

93 Burlington Industries, Inc v Ellerth, 524 U.S 742, 756 (1998)

94 Dunlap v W.L Logan Trucking Co., 161 Ohio App 3d 51 (2005)

95 Dunlap v W.L Logan Trucking Co., 161 Ohio App 3d 51, 66 (2005)

96 Dunlap v W.L Logan Trucking Co., 161 Ohio App 3d 51, 67 (2005)

97 Dunlap v W.L Logan Trucking Co., 161 Ohio App 3d 51, 68 (2005)

98 Dunlap v W.L Logan Trucking Co., 161 Ohio App 3d 51, 69 (2005)

99 Martinez v CO2 Services, Inc., No 00-2218, slip op at 7, (10th Cir April 12, 2001)

100 10 N.Y Comp Codes & Regs., tit 10, § 405.4 (2002) First enacted in 1989, the tions limit resident scheduling to no more than 80 hours per week, averaged over four weeks Shifts are limited to 24 hours with flexibility for certain surgery residents Violators face significant monetary fines

regula-101 Baggett v Brumfield, 758 So.2d 332, 336 (La App.3d Cir 2000)

102 Faverty v McDonald’s Restaurants of Oregon, Inc., 133 Or App 514, 893 P.2d

703 (1995)

103 Snowbarger v Tri-County Electric Coop., 793 S.W.2d 348 (Mo 1990) (electric lineman worked 86 of 100 hour work period during snow emergency and fell asleep at the

wheel); Van Devander v Heller Electric Co., 405 F.2d 1108 (D.C.Cir 1968) (an electrical equipment installer worked twenty-six consecutive hours on the job and fell asleep from fatigue).

104 Maryland Transit Administration Light Rail Vehicle Accidents at the Washington International Airport Transit Station near Baltimore, Maryland, February

Baltimore-13 and August 15, 2000, Railroad Special Investigation Report NTSB/SIR- 01/02 (Washington, D.C: NTSB, 2001); and Grounding of the Liberian Passenger Ship STAR PRINCESS on Poundstone Rock, Lynn Canal, Alaska, June 23, 1995, Marine Accident Report NTSB/MAR-97/02 (Washington, D.C: NTSB, 1997)

105 National Safety Transportation Board Report No RAR-02/04, 27, “Railroad Accident Report, Collision of Two Canadian National/Illinois Central Railway Trains Near Clarkston, Michigan, November 15, 2001,” (November 19, 2002)

106 National Safety Transportation Board Report No RAR-02/04, 28 (November 19, 2002)

107 Department of Transportation, Federal Railroad Administration, “Notice of Safety Advisory 2004-04; Effect of Sleep Disorders on Safety of Railroad Operations,” 69 Fed Reg 190, 58995, 58996 (October 1, 2004)

108 49 CFR § 391.41

109 49 CFR § 391.41(b)(5), (8)

110 49 CFR § 391.43; Final Rule, Department of Transportation, Federal Motor Carrier Safety Administration, “Physical Qualification of Drivers; Medical Examination; Certificate,”

65 Fed Reg 194, 59363-59380 (October 5, 2000)

111 Federal Motor Carrier Safety Administration, Advisory Criteria, The Conference on Pulmonary/Respiratory Disorders and Commercial Drivers, FHWA-MC-91-004, at 5 (1991), http://www.fmcsa.dot.gov/documents/pulmonary1.pdf, (accessed March 2006)

112 Federal Motor Carrier Safety Administration, Advisory Criteria; Conference on Neurological Disorders and Commercial Drivers at: http://www.fmcsa.dot.gov/rules-regs/medreports.html “Seizures, Epilepsy and Interstate Commercial Driving,” http://www.fmcsa.dot.gov/documents/neuro2.pdf

113 Electronic Guide for Aviation Medical Examiners, http://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/media/sec3.pdf, 61, (July 31, 2005) (accessed March 2006)

114 Electronic Guide for Aviation Medical Examiners, “AASI For History of Sleep Apnea,” (January 16, 2006), http://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/media/aasisleep.pdf (accessed March 2006)

115 10 CFR Part 26, 54 Fed Reg 24468

116 Nuclear Regulatory Commission, Proposed Rule, “Fitness for Duty Programs,” 70 Fed Reg 165 50442-50620 (August 26, 2005)

117 42 U.S.C § 1395nn

118 66 Fed Reg 3; 880 (January 4, 2001)

119 42 U.S.C § 1395nn(h)(6)(F)

William C Dement

Stanford Sleep Research Center, Palo Alto, California, U.S.A.

Obstructive sleep apnea (OSA) and other sleep-related breathing disorders are ably the number one health problem in the United States if not the entire world Given the high prevalence, it is amazing that this problem was completely unknown

argu-to the general public as well as health professionals as recently as 1965 and mostly unknown until the late 1970s In addition to the actual obstructive sleep disorder itself, there are strong associations with cardiovascular disease, fatigue, mental impairment, diabetes, obesity, and probably a host of other less well-documented associations.

All of the above receives a detailed description in these two volumes It is worth noting that early on, Stanford sleep specialists realized the high prevalence of OSA We also realized that a standard model to deal with the condition should be established Finally, we knew it would be necessary to start training other physi- cians to diagnose and treat OSA This led directly to the establishment of the formal clinical practice specialty of sleep medicine, which deals exclusively with the diag- nosis and treatment of sleep disorders.

As with anything else, there are those who insist on only the most high-tech approaches This is no longer appropriate I have always said probably 90% of vic-

tims can be identified by asking two questions: (i) Do you snore loudly or does the bed partner, if there is one, complain? and (ii) Are you unusually tired when you are

awake throughout the daytime with no apparent cause? If the answers to both the foregoing questions are “yes,” OSA is highly likely Keep in mind that indi- viduals often do not seem to be aware of their fatigue, and among other individuals there is often a misapprehension that the tiredness is caused by depression, anemia,

or some other esoteric problem Any time there is loud snoring, check it out As I have indicated, checking it out could not be easier In fact, an educated bed partner can easily assess the implications of the snoring.

One of the problems we have encountered is that this area of human behavior

is strange and frightening to many people Some years ago, we showed a film clip

of patients being treated with continuous positive airway pressure (CPAP) to a group of burly, tough, long-haul truck drivers They were visibly shaken by the strangeness of patients sleeping with CPAP machines Therefore, bestowing the benefits of the diagnosis of OSA on most individuals will certainly require extra efforts of persuading and convincing.

All of this is very ambitious, but clearly, as the large-scale clinical trials such as the Apnea Positive Pressure Long-term Efficacy Study (APPLES) now being con- ducted demonstrate, there is a pressing need for additional research in the service

of prevention and diagnostic methodologies for all potential patient populations, including infants and children There is promise of meeting some of this need in the near future, as less expensive and more accessible diagnostic tools, such as portable monitoring, are now being evaluated as a reasonable alternative to the in-laboratory polysomnogram Above all, there is an even greater need for research in the service

of the development of new treatment modalities and conclusive testing of those

currently available Partnerships between academia and industry, once frowned upon but now viewed as almost a codependent relationship, can help to foster the development of these newer treatment technologies It is important to realize that the field of apnea treatment has made significant advances since the development

of CPAP a little over a quarter of a century ago, but much more needs to be plished in sleep apnea patient care and research to develop treatments that are more palatable and accessible to those with this debilitating condition.

accom-I have taught “Sleep and Dreams,” which is the largest undergraduate course

at Stanford, for over 30 years During this time, I have witnessed countless personal stories in which students have learned about sleep apnea through my course and then subsequently educated and encouraged their family and friends suspected of having sleep apnea to obtain professional help for their condition Based on this experience, there is a need to promote more education about sleep apnea and other sleep disorders not only at the medical or graduate student, resident, and practicing physician levels, but also at the undergraduate student levels Only in doing so can

we increase the awareness of this condition within the general public as well as to encourage others to enter the field to find better diagnostic and treatment options for sleep apnea sufferers.

There have been strong efforts in the public awareness and advocacy sectors, notably the National Commission on Sleep Disorders Research which issued its final report “Wake Up America: A National Sleep Alert” in 1993 after its two-year study, and more recently, the Institute of Medicine’s report, “Sleep Disorders and Sleep Deprivation: An Unmet Public Health Problem,” which was released in 2006 Given the existence of the National Center on Sleep Disorders Research in the National Heart, Lung and Blood Institute and the scope of the problem, it is abso- lutely essential that this center be accorded a much higher priority and a much larger budget from its parent institute and/or the US Congress, or perhaps it should

be a freestanding entity At the moment, the will to strongly advocate such ments does not seem to exist among patients and practitioners, but the professional organizations representing this field, to wit, the American Academy of Sleep Medicine, the Sleep Research Society, the American Association of Sleep Technologists, and the National Sleep Foundation must respond to the challenge There are also patient orga- nizations, in particular the American Sleep Apnea Association as well as smaller local organizations The moral imperative, however, is that we can and therefore we must deplore the diminished health, quality of life, and shortened-life expectancy of human beings afflicted with OSA and because we can, we must work as hard as possible to change their lives for the better.

ADA See Americans with Disabilities Act

Adaptive servo-ventilation, 125, 134 See also

Bilevel pressure and adaptive

positive airway pressure therapy, 159

Airway bypass surgery, 210

Alprazolam (Xanax, Niravam), 301

ALS See Amyotrophic lateral sclerosis

Alveolar hypoventilationclinical features, 176Alzheimer’s disease, 285, 370–371Ambien®, 234, 302

Ambulatory diagnostic system, 30Americans with Disabilities Act (ADA), 414Aminorex (Menocil), 236

Amlodipine (Norvasc), 299Amyotrophic lateral sclerosis (ALS), 378–379

NIPPV, 176Androgens, 234Anesthetics, 301Angina, nocturnal, OSA, 7Angiotensin-converting enzyme inhibitors, 299

ANN See Artificial neural networks

Antacids, GER, 396Antiepileptic drug side effects, 349Antihypertensive medications, 296Antipsychotics, 300

insomnia, 350–351OSA portable monitoring, 51–53pediatric OSA, 269–270Apnea Positive Pressure Long-term Efficacy Study (APPLES), 425

Apneas, 2–3 See also specific apnea

pons, 368

APPLES See Apnea Positive Pressure

Long-term Efficacy StudyARES Unicorder, 28

Arnold Chiari malformations, 377Arousal disorders, 359

Arrhythmias, cardiac, diagnosis, 38–39Artificial neural networks (ANN), 23

CPAP cost and reimbursement, 116–117

Auto-positive airway pressure (APAP),

BMI See Body mass index

Body mass index (BMI), 22, 235geriatric OSA, 282

Bötzinger complex, 369

BPAP See Bilevel PAP

Bromocriptine (Parlodel), 239Bronchial asthma vs OSAquality of life, 342–343Bronchiectasis, NIPPV, 176Bullying, 267

Bupivacaine (Marcaine), 234

Bushnell v Bushnell, 406–407

Butalbital, 301C-Flex, 110, 140

CAD See Coronary artery disease

Caffeine, GER, 396Calcium channel blockers, 299GER, 396

Canadian CPAP Trial for Congestive Health Failure Patients with Central Apnea (CANPAP), 116, 328

Cardiac arrhythmia diagnosis, 38–39Cardiac failure, CPAP, 116

Cardiac medications, 299Cardiorespiratory monitoring, 35–60Cardiovascular disease, 398–400Cardiovascular outcomes, CPAP, 115–116

Cardiovascular risk factor reduction, OSA, 235

Cataplexy, 4Catapres, 299Central hyperventilation, midbrain, 368Central nervous system (CNS)disorders, 368, 370–375Central sleep apnea (CSA), 38, 301, 321–332

acromegaly, 326

[Central sleep apnea (CSA)]

aging, 324

bilevel pressure and adaptive

servo-ventilation, 130

cerebrovascular disease, 325

congestive heart failure, 325

continuous positive airway pressure therapy,

Cerebrovascular disease, CSA, 325

Certificate of need (CON) and licensure

Child Behavioral Checklist, 267

Children See Pediatric

Choking, 2–3

Choline esterase inhibitor, 372

Chronic hypercapnic respiratory failure

NIMV, 340

Chronic hypoxemia, 379Chronic obstructive pulmonary disease (COPD), 333–337, 392–394airflow limitation, 334diagnosis and management, 339–340diaphragm, 336

gas exchange during sleep, 333–334hypertension, 393

long-term oxygen therapy, 334–335NIPPV, 394

nocturnal desaturation, 335nocturnal hypoxemia, 334treatment, 340

nocturnal oximetry, 339–340noninvasive mechanical ventilation (NIMV), 340–341

physiological variables, 334positive airway pressure therapy, 154respiratory muscles, 336

SDB, 337–338sleep quality, 338–339sleep studies, 340Claustrophobiapositive airway pressure therapy, 159Cleveland Family Study, 9

Clonazepam (Klonopin), 301, 372Clonidine (Catapres), 299

CMT See Charcot-Marie-Tooth CNS See Central nervous system

Cognitiongeriatric SDB, 284–285pediatric SDB, 268Computed tomography (CT)upper airway imaging, 65–66

CON See Certificate of need (CON) and

licensure lawsCongenital craniofacial syndromes, 14Congestive heart failure

CSA, 325geriatric SDB, 284Conners Parent Rating Scale-Revised:Long, 267Continuous positive airway pressure (CPAP), 101–124, 255

adherence, 111–113Alzheimer’s disease, SRBD, 371

vs APAP, 145–146assessment, 104asthma, 391–392baseline indicators, 113benefits, 151–152blood pressure, 115–116cardiac failure, 116