Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults

Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults

 

Guideline Summary NGC-7517

Guideline Title

Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults.

Bibliographic Source(s)

Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM,

Weinstein MD, Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline

for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med 2009 Jun

15;5(3):263-76. PubMed

Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Obstructive sleep apnea (OSA)

Guideline Category

Counseling

Diagnosis

Evaluation

Management

Risk Assessment

Treatment

Clinical Specialty

Dentistry

Family Practice

Geriatrics

Internal Medicine

Otolaryngology

Pulmonary Medicine

Sleep Medicine

Surgery

Intended Users

Advanced Practice Nurses

Dentists

Health Care Providers

Physician Assistants

Physicians

Respiratory Care Practitioners

Guideline Objective(s)

To assist primary care providers as well as sleep medicine specialists, surgeons, and dentists who care for patients

with obstructive sleep apnea (OSA) by providing a comprehensive strategy for the evaluation, management, and longterm

care of adult patients with OSA

Target Population

Adults diagnosed with or at high risk for obstructive sleep apnea

Interventions and Practices Considered

Diagnosis

1. History and physical examination: comprehensive sleep history and comprehensive examination of the

respiratory, cardiovascular, and neurological systems

2. Objective testing:

care of adult patients with OSA

Target Population

Adults diagnosed with or at high risk for obstructive sleep apnea

Interventions and Practices Considered

Diagnosis

1. History and physical examination: comprehensive sleep history and comprehensive examination of the

respiratory, cardiovascular, and neurological systems

2. Objective testing:

l Polysomnography

l Testing with portable monitors

l The multiple sleep latency test (MSLT)

Patient Education

Reviewing results of objective testing with the patient, including education on the nature of the disorder and treatment

options

Treatment

1. Positive airway pressure (PAP)

2. Behavioral treatment: weight loss, ideally to a body mass index of 25 kg/m2 or less; exercise; positional

therapy; and avoidance of alcohol and sedatives before bedtime

3. Oral appliances: mandibular repositioning appliances (MRA), tongue retaining devices (TRD)

4. Surgical treatment: a variety of upper airway reconstructive or bypass procedures

Adjunctive Therapies

1. Bariatric surgery

2. Oxygen supplementation (not recommended as a primary treatment)

3. Medication, such as modafinil or topical nasal corticosteroids

Major Outcomes Considered

l Therapy-specific efficacy

l Resolution of sleepiness

l Changes in obstructive sleep apnea (OSA)-specific quality of life measures

l Patient and spousal satisfaction

l Adherence to therapy

Methodology

Methods Used to Collect/Select the Evidence

Hand-searches of Published Literature (Secondary Sources)

Searches of Electronic Databases

Description of Methods Used to Collect/Select the Evidence

All existing American Association of Sleep Medicine (AASM) practice parameters relevant to the evaluation and

management of obstructive sleep apnea (OSA) in adults were incorporated into the development of this guideline.

These parameters were previously developed via a computerized, systematic search of the scientific literature (for

specific search terms and further details, see referenced practice parameters in the original guideline) and subsequent

critical review, evaluation, and evidence grading. On the basis of these reviews the AASM Standards of Practice

Committee developed practice parameters.

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Weighting According to a Rating Scheme (Scheme Given)

Rating Scheme for the Strength of the Evidence

Classification of Evidence for Evidence-Based Recommendations

Level I. Randomized well-designed trials with low alpha and beta error*

Level II. Randomized trials with high alpha and beta error*

Level III. Nonrandomized concurrently controlled studies

Level IV. Nonrandomized historically controlled studies

Level V. Case series

*Alpha (type I error) refers to the probability that the null hypothesis is rejected when in fact it is true (generally acceptable at 5% or less,

or p<0.05). Beta (type II error) refers to the probability that the null hypothesis is mistakenly accepted when in fact it is false (generally,

trials accept a beta error of 0.20). The estimation of type II error is generally the result of a power analysis. The power analysis takes into

account the variability and the effect size to determine if sample size is adequate to find a difference in means when it is present (power

generally acceptable at 80% to 90%).

Adapted from Sackett DL. Rules of evidence and clinical recommendations for the management of patients. Can J Cardiol 1993;9:487-9.

Level IV. Nonrandomized historically controlled studies

Level V. Case series

*Alpha (type I error) refers to the probability that the null hypothesis is rejected when in fact it is true (generally acceptable at 5% or less,

or p<0.05). Beta (type II error) refers to the probability that the null hypothesis is mistakenly accepted when in fact it is false (generally,

trials accept a beta error of 0.20). The estimation of type II error is generally the result of a power analysis. The power analysis takes into

account the variability and the effect size to determine if sample size is adequate to find a difference in means when it is present (power

generally acceptable at 80% to 90%).

Adapted from Sackett DL. Rules of evidence and clinical recommendations for the management of patients. Can J Cardiol 1993;9:487-9.

Methods Used to Analyze the Evidence

Systematic Review

Description of the Methods Used to Analyze the Evidence

Existing practice parameters relevant to the evaluation and management of obstructive sleep apnea in adults were

previously developed via a computerized, systematic search of the scientific literature and subsequent critical review,

evaluation, and evidence grading. On the basis of these reviews the American Academy of Sleep Medicine (AASM)

Standards of Practice Committee developed practice parameters. Practice parameters were designated as “Standard,”

“Guideline,” or “Option” based on the level and amount of scientific evidence available (see the “Rating Scheme for the

Strength of the Evidence” and the “Rating Scheme for the Strength of the Recommendations” fields).

Methods Used to Formulate the Recommendations

Expert Consensus (Nominal Group Technique)

Description of Methods Used to Formulate the Recommendations

The Board of Directors of the American Academy of Sleep Medicine (AASM) assembled the Adult Obstructive Sleep

Apnea (OSA) Task Force in January 2007 to review available literature and produce a clinical guideline for the

evaluation, management, and long-term care of adult patients with OSA.

The Adult OSA Task Force constructed the clinical guidelines from the current practice parameters. The practice

parameters, which are updated every 5 years, were not revised by the task force. Consensus-based recommendations

were developed to address important areas of clinical practice that had not been the subject of a previous AASM

practice parameter, or where the available empirical data were limited or inconclusive. The Task Force held face-to-face

meetings where members of the panel presented reviews of the current literature on consensus topics.

Recommendations were generated by panel members and discussed by all. To minimize individual expert bias, the

group voted anonymously and rated consensus recommendations using a modified nominal group technique. All task

force members voted on all questions. If a first round vote was inconclusive, a second anonymous vote was conducted.

Consensus-based recommendations reflect the shared judgment of the committee members and reviewers, based on

the literature and common clinical practice of topic experts. The consensus statements regarding the use of portable

monitors were developed, employing similar methods, by the Portable Monitoring Task Force of the AASM for use in a

previous guideline document.

Rating Scheme for the Strength of the Recommendations

Levels of Recommendation

Standard: This is a generally accepted patient-care strategy that reflects a high degree of clinical certainty. The term

standard generally implies the use of Level I evidence, which directly addresses the clinical issue, or overwhelming

Level II evidence.

Guideline: This is a patient-care strategy that reflects a moderate degree of clinical certainty. The term guideline

implies the use of Level II evidence or a consensus of Level III evidence.

Option: This is a patient-care strategy that reflects uncertain clinical use. The term option implies either inconclusive

or conflicting evidence or conflicting expert opinion.

Adapted from Eddy DM (Ed.). A manual for assessing health practices and designing practice policies: the explicit approach. Philadelphia, PA:

American College of Physicians; 1992.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

Internal Peer Review

Description of Method of Guideline Validation

The Board of Directors of the American Academy of Sleep Medicine approved these recommendations.

Recommendations

Major Recommendations

Diagnosis

The presence or absence and severity of obstructive sleep apnea (OSA) must be determined before initiating treatment

in order to identify those patients at risk of developing the complications of sleep apnea, guide selection of appropriate

treatment, and to provide a baseline to establish the effectiveness of subsequent treatment. Diagnostic criteria for

OSA are based on clinical signs and symptoms determined during a comprehensive sleep evaluation, which includes a

sleep oriented history and physical examination, and findings identified by sleep testing (Standard).

The overall evaluation of patients suspected of having OSA is summarized in Figure 1 of the original guideline

document.

History and Physical Examination

The diagnosis of OSA starts with a sleep history that is typically obtained in one of three settings: first, as part of

routine health maintenance evaluation; second, as part of an evaluation of symptoms of obstructive sleep apnea; and

third, as part of the comprehensive evaluation of patients at high risk for OSA. High-risk patients include those who are

The presence or absence and severity of obstructive sleep apnea (OSA) must be determined before initiating treatment

in order to identify those patients at risk of developing the complications of sleep apnea, guide selection of appropriate

treatment, and to provide a baseline to establish the effectiveness of subsequent treatment. Diagnostic criteria for

OSA are based on clinical signs and symptoms determined during a comprehensive sleep evaluation, which includes a

sleep oriented history and physical examination, and findings identified by sleep testing (Standard).

The overall evaluation of patients suspected of having OSA is summarized in Figure 1 of the original guideline

document.

History and Physical Examination

The diagnosis of OSA starts with a sleep history that is typically obtained in one of three settings: first, as part of

routine health maintenance evaluation; second, as part of an evaluation of symptoms of obstructive sleep apnea; and

third, as part of the comprehensive evaluation of patients at high risk for OSA. High-risk patients include those who are

obese; those with congestive heart failure, atrial fibrillation, treatment refractory hypertension, type 2 diabetes,

stroke, nocturnal dysrhythmias, pulmonary hypertension; high-risk driving populations (such as commercial truck

drivers); and those being evaluated for bariatric surgery (Consensus).

Questions to be asked during a routine health maintenance evaluation should include a history of snoring and daytime

sleepiness and an evaluation for the presence of obesity, retrognathia, or hypertension (Consensus). Positive findings

on this OSA screen should lead to a more comprehensive sleep history and physical examination.

A comprehensive sleep history in a patient suspected of OSA should include an evaluation for snoring, witnessed

apneas, gasping/choking episodes, excessive sleepiness not explained by other factors, including assessment of

sleepiness severity by the Epworth Sleepiness Scale, total sleep amount, nocturia, morning headaches, sleep

fragmentation/sleep maintenance insomnia, and decreased concentration and memory (Consensus). An evaluation of

secondary conditions that may occur as a result of OSA, including hypertension, stroke, myocardial infarction, cor

pulmonale, decreased daytime alertness, and motor vehicle accidents, should also be obtained (Consensus).

The physical examination can suggest increased risk and should include the respiratory, cardiovascular, and neurologic

systems. Particular attention should be paid to the presence of obesity, signs of upper airway narrowing, or the

presence of other disorders that can contribute to the development of OSA or to the consequences of OSA. Features to

be evaluated that may suggest the presence of OSA include increased neck circumference (>17 inches in men, >16

inches in women), body mass index (BMI) ≥30 kg/m2, a Modified Mallampati score of 3 or 4, the presence of

retrognathia, lateral peritonsillar narrowing, macroglossia, tonsillar hypertrophy, elongated/enlarged uvula, high

arched/narrow hard palate, nasal abnormalities (polyps, deviation, valve abnormalities, turbinate hypertrophy) and/or

overjet (Consensus).

Following the history and physical examination, patients can be stratified according to their OSA disease risk. Those

patients deemed high risk should have the diagnosis confirmed and severity determined with objective testing in an

expedited manner in order to initiate treatment. For other patients, the timing of further testing is determined by the

risk of OSA and the presence of daytime impairment or associated morbidity. As part of the initial sleep evaluation,

and prior to objective testing, patients should receive education regarding possible diagnoses, diagnostic steps, and

the procedure involved in any testing (Consensus).

Objective Testing

The severity of OSA must be established in order to make an appropriate treatment decision. No clinical model is

recommended to predict severity of obstructive sleep apnea (Option), therefore objective testing is required. A

diagnosis of OSA must be established by an acceptable method (Standard). The two accepted methods of objective

testing are in-laboratory polysomnography (PSG) and home testing with portable monitors (PMs). For specifics on the

parameters to be measured with PSG and PM, see the sections below. PSG is routinely indicated for the diagnosis of

sleep-related breathing disorders (Standard). PMs may be used to diagnose OSA when utilized as part of a

comprehensive sleep evaluation in patients with a high pretest likelihood of moderate to severe OSA (Consensus). PM

testing is not indicated in patients with major comorbid conditions including, but not limited to, moderate to severe

pulmonary disease, neuromuscular disease, or congestive heart failure, or those suspected of having a comorbid sleep

disorder (Consensus).

High-risk patients with nocturnal symptoms of OSA should undergo sleep testing, including those who are obese

and those with systolic or diastolic heart failure (Standard), coronary artery disease (Guideline), history of stroke or

transient ischemic attacks (Option), or significant tachyarrhythmias or bradyarrhythmias (Guideline). Patients with

congestive heart failure who continue to have nocturnal symptoms of sleep-related breathing disorders despite optimal

medical management are also at risk for OSA and should undergo testing (Standard). Patients with hypertension

should undergo evaluation and testing if they have nocturnal symptoms (disturbed sleep, nocturnal dyspnea, or

snoring) suggestive of OSA or if they remain hypertensive despite optimal medical management (Consensus). A

preoperative clinical evaluation that includes PSG or PM is routinely indicated to evaluate for the presence of OSA in

patients before they undergo upper airway surgery for snoring or OSA (Standard). A preoperative clinical sleep

evaluation that includes PSG is recommended to evaluate for the presence of OSA in patients before they undergo

bariatric surgery (Consensus). PM testing may also be indicated for the diagnosis of OSA in patients for whom inlaboratory

PSG is not possible by virtue of immobility, safety, or critical illness and to monitor response to noncontinuous

positive airway pressure (CPAP) therapies (Consensus).

Follow-up PSG or attended cardiorespiratory (type 3 PM) sleep study is routinely indicated for the assessment of

treatment results after surgical treatment for moderate to severe OSA (Standard). To ensure satisfactory therapeutic

benefit from oral appliances (OA), patients with OSA should undergo PSG or an attended cardiorespiratory (type 3 PM)

sleep study with the OA in place after final adjustments of fit have been performed (Guideline). Also, unattended PM

may be indicated to monitor the response to non-CPAP treatments for OSA, including OAs, upper airway surgery, and

weight loss (Consensus). Follow-up PSG or attended cardiorespiratory (type 3 PM) sleep study is routinely indicated to

assess treatment results after surgical or dental treatment for sleep-related breathing disorders when symptoms

return, despite a good initial response to treatment (Standard). Follow-up PSG is routinely indicated in OSA patients

for the assessment of treatment results on CPAP after substantial weight loss (e.g., 10% of body weight), substantial

weight gain with return of symptoms, when clinical response is insufficient, or symptoms return despite a good initial

response to CPAP (Standard). Follow-up PSG or PM is not routinely indicated in patients treated with CPAP whose

symptoms continue to be resolved with CPAP treatment (Option).

Polysomnography

The use of PSG for evaluating OSA requires recording the following physiologic signals: electroencephalogram (EEG),

electrooculogram (EOG), chin electromyogram, airflow, oxygen saturation, respiratory effort, and electrocardiogram

(ECG) or heart rate. Additional recommended parameters include body position and leg EMG derivations. Anterior

tibialis EMG is useful to assist in detecting movement arousals and may have the added benefit of assessing periodic

limb movements, which coexist with sleep-related breathing disorders (SRBD) in many patients (Standard). An

attended study requires the constant presence of a trained individual who can monitor for technical adequacy, patient

compliance, and relevant patient behavior (Guideline). Technical personnel should have appropriate sleep-related

training. Current training pathways include on the job training utilizing the Accredited Sleep Technologist Education

Program (A-STEP) or college-based training in a sleep technology program accredited by the Commission on

Accreditation of Allied Health Education Programs (CAAHEP). The final pathway for demonstration of competency is

certification, through the Board of Registered Polysomnographic Technologists (BRPT) or its equivalent. Technologist

progression to certification is now required to meet American Academy of Sleep Medicine (AASM) accreditation

Polysomnography

The use of PSG for evaluating OSA requires recording the following physiologic signals: electroencephalogram (EEG),

electrooculogram (EOG), chin electromyogram, airflow, oxygen saturation, respiratory effort, and electrocardiogram

(ECG) or heart rate. Additional recommended parameters include body position and leg EMG derivations. Anterior

tibialis EMG is useful to assist in detecting movement arousals and may have the added benefit of assessing periodic

limb movements, which coexist with sleep-related breathing disorders (SRBD) in many patients (Standard). An

attended study requires the constant presence of a trained individual who can monitor for technical adequacy, patient

compliance, and relevant patient behavior (Guideline). Technical personnel should have appropriate sleep-related

training. Current training pathways include on the job training utilizing the Accredited Sleep Technologist Education

Program (A-STEP) or college-based training in a sleep technology program accredited by the Commission on

Accreditation of Allied Health Education Programs (CAAHEP). The final pathway for demonstration of competency is

certification, through the Board of Registered Polysomnographic Technologists (BRPT) or its equivalent. Technologist

progression to certification is now required to meet American Academy of Sleep Medicine (AASM) accreditation

standards, Center for Medicare and Medicaid Services Independent Diagnostic Testing Facility regulations, and multiple

state credentialing and licensing regulations.

The parameters, settings, filters, technical specifications, sleep stage scoring and event scoring should be done in

accordance with the AASM Manual for the Scoring of Sleep and Associated Events. The frequency of obstructive events

is reported as an apnea + hypopnea index (AHI) or respiratory disturbance index (RDI). The definition of this index has

varied over time. When an index is reported in this guideline it was taken directly from the specific practice parameter

and the reader is referred to the source document for the definition. Every sleep study should be reviewed and

interpreted by a qualified physician, as defined in the AASM Accreditation Standards (Consensus). Interscorer

reliability assessment and other quality assurance measures should be performed on a regular basis. Formal written

policies should be in place for all procedures. The most accepted measure of quality is sleep center or laboratory

accreditation by the AASM (Consensus).

Full-night PSG is recommended for the diagnosis of a sleep-related breathing disorder but a split-night study (initial

diagnostic PSG followed by CPAP titration on the same night) is an alternative to one full night of diagnostic PSG. The

split-night study may be performed if an AHI ≥40/hr is documented during 2 hours of a diagnostic study but may be

considered for an AHI of 20 to 40/hr based on clinical judgment. In patients where there is a strong suspicion of OSA, if

other causes for symptoms have been excluded, a second diagnostic overnight PSG may be necessary to diagnose the

disorder.

The diagnosis of OSA is confirmed if the number of obstructive events (apneas, hypopneas + respiratory event–

related arousals) on PSG is greater than 15 events/hr or greater than 5/hr in a patient who reports any of the following:

unintentional sleep episodes during wakefulness; daytime sleepiness; unrefreshing sleep; fatigue; insomnia; waking up

breath holding, gasping, or choking; or the bed partner describing loud snoring, breathing interruptions, or both during

the patient’s sleep. OSA severity is defined as mild for RDI ≥ 5 and < 15, moderate for RDI ≥ 15 and ≤ 30, and severe

for RDI > 30/hr (Consensus).

Testing with PMs

PM for the diagnosis of OSA should be performed only in conjunction with a comprehensive sleep evaluation. Clinical

sleep evaluations using PM must be supervised by a practitioner with board certification in sleep medicine or an

individual who fulfills the eligibility criteria for the sleep medicine certification examination (Consensus).

A PM should, at a minimum, record airflow, respiratory effort, and blood oxygenation. The type of biosensors used to

monitor these parameters for in-laboratory PSG are recommended for use in PMs and include an oronasal thermal

sensor to detect apneas, a nasal pressure transducer to measure hypopneas, oximetry, and, ideally, calibrated or

uncalibrated inductance plethysmography for respiratory effort (Consensus). An experienced sleep technician, sleep

technologist, or appropriately trained healthcare practitioner must perform the application of PM sensors or directly

educate the patient in the correct application of the sensors (Consensus). PM should be performed under the auspices

of an AASM-accredited comprehensive sleep medicine program with policies and procedures for sensor application,

scoring, and interpretation of the collected data. A quality/performance improvement program for PM including interscorer

reliability must be in place to assure accuracy and reliability.

PMs may be used in the unattended setting as an alternative to PSG for the diagnosis of OSA in patients with a high

pretest probability of moderate to severe OSA and no comorbid sleep disorder or major comorbid medical disorders

when all of the previous parameters are met (Consensus). The diagnosis of OSA is confirmed and severity determined

using the same criteria as used for PSG. Scoring criteria should be consistent with the current published AASM

standards for scoring of apneas and hypopneas (Consensus). The term RDI has been defined differently when used

with PMs than when used with PSG. RDI PM is the number of apneas + hypopneas / total recording time rather than

total sleep time. As a result, PMs are likely to underestimate the severity of events compared to the AHI by PSG. Due

to the known rate of false negative PM tests, in-laboratory PSG should be performed in cases where PM is technically

inadequate or fails to establish the diagnosis of OSA in patients with a high pretest probability (Consensus).

Other Sleep Procedures

The multiple sleep latency test (MSLT) is not routinely indicated in the initial evaluation and diagnosis of OSA or in an

assessment of change following treatment with nasal CPAP. However, if excessive sleepiness continues despite

optimal treatment, the patient may require an evaluation for possible narcolepsy, including the MSLT (Guideline).

Actigraphy alone is not indicated for the routine diagnosis of OSA but may be a useful adjunct to PMs when

determining the rest-activity pattern during the testing period (Option). Autotitrating positive airway pressure (APAP)

is not recommended to diagnose OSA.

Patient Education

The sleep specialist should review the results of objective testing with the patient, including education on the nature

of the disorder and treatment options (see Table 5 in the original guideline document). The educational program should

include discussion of the pathophysiology, risk factors, natural history, and clinical consequences of OSA. Treatment

options should be discussed in the context of the severity of the patient’s OSA, their risk factors, any associated

conditions, and the patient’s expectations. General education on the impact of weight loss, sleep position, alcohol

avoidance, risk factor modification, and medication effects should be provided. The patient should be counseled on the

risks and management of drowsy driving. Patient education should optimally be delivered as part of a multidisciplinary

chronic disease management team including the sleep physician, the referring provider, and allied health care

providers. In addition, videotapes, handouts, websites, and brochures can be employed (Consensus).

Treatment

OSA should be approached as a chronic disease requiring long-term, multidisciplinary management. There are medical,

behavioral, and surgical options for the treatment of OSA. Adjunctive therapies are used as needed to supplement the

primary treatment options. The patient should be an active participant in the decision on treatment type and taught to

contribute to the management of his or her own disease. Positive airway pressure (PAP) is the treatment of choice for

mild, moderate, and severe OSA and should be offered as an option to all patients (Consensus). Alternative therapies

may be offered depending on the severity of the OSA and the patient’s anatomy, risk factors, and preferences and

should be discussed in detail. (See Figure 1 in the original guideline document.)

A general OSA outcomes assessment should be performed on all patients following the initiation of therapy. Outcome

indicators to monitor with therapy include evaluation of resolution of sleepiness (using subjective scales such as the

providers. In addition, videotapes, handouts, websites, and brochures can be employed (Consensus).

Treatment

OSA should be approached as a chronic disease requiring long-term, multidisciplinary management. There are medical,

behavioral, and surgical options for the treatment of OSA. Adjunctive therapies are used as needed to supplement the

primary treatment options. The patient should be an active participant in the decision on treatment type and taught to

contribute to the management of his or her own disease. Positive airway pressure (PAP) is the treatment of choice for

mild, moderate, and severe OSA and should be offered as an option to all patients (Consensus). Alternative therapies

may be offered depending on the severity of the OSA and the patient’s anatomy, risk factors, and preferences and

should be discussed in detail. (See Figure 1 in the original guideline document.)

A general OSA outcomes assessment should be performed on all patients following the initiation of therapy. Outcome

indicators to monitor with therapy include evaluation of resolution of sleepiness (using subjective scales such as the

Epworth Sleepiness Scale or objective measures such as the multiple sleep latency test or maintenance of wakefulness

test if sleepiness persists despite effective treatment), OSA-specific quality of life measures, patient and spousal

satisfaction, adherence to therapy, avoidance of factors worsening disease, obtaining an adequate amount of sleep,

practicing proper sleep hygiene, and weight loss for overweight/obese patients (Consensus). Additional therapyspecific

outcomes should also be assessed as described below.

Positive Airway Pressure

PAP provides pneumatic splinting of the upper airway and is effective in reducing the AHI. PAP may be delivered in

continuous (CPAP), bilevel (BPAP), or autotitrating (APAP) modes. Partial pressure reduction during expiration (pressure

relief) can also be added to these modes. PAP applied through a nasal, oral, or oronasal interface during sleep is the

preferred treatment for OSA. CPAP is indicated for the treatment of moderate to severe OSA (Standard) and mild OSA

(Option). CPAP is also indicated for improving self-reported sleepiness (Standard), improving quality of life (Option),

and as an adjunctive therapy to lower blood pressure in hypertensive patients with OSA (Option). The approach to

initiation, management, and follow-up of CPAP is summarized in Figure 2 in the original guideline document.

Full-night, attended PSG performed in the laboratory is the preferred approach for titration to determine the optimal

PAP level; however, split-night, diagnostic-titration studies are usually adequate (Guideline). APAP devices are not

currently recommended for split-night titration (Standard). Guidelines have recently been published on the method for

conducting CPAP and BPAP titrations. Certain APAP devices may be used during attended titration with PSG to identify

a single pressure for use with standard CPAP for treatment of moderate to severe OSA (Guideline). Certain APAP

devices may be used in an unattended way to determine a fixed CPAP treatment pressure for patients with moderate to

severe OSA without significant comorbidities (congestive heart failure [CHF], chronic obstructive pulmonary disease

[COPD], central sleep apnea syndromes, or hypoventilation syndromes) (Option).

BPAP, pressure relief, or APAP can be considered in the management of OSA in CPAP-intolerant patients (Consensus).

While the literature mainly supports CPAP therapy, BPAP is an optional therapy in some cases where high pressure is

needed and the patient experiences difficulty exhaling against a fixed pressure or coexisting central hypoventilation is

present (Guideline). Pressure waveform modification technologies (such as pressure relief) may improve patient

comfort and adherence with PAP (Consensus). Certain APAP devices may be initiated and used in the self-adjusting

mode for unattended treatment of patients with moderate to severe OSA without significant comorbidities (congestive

heart failure [CHF], chronic obstructive pulmonary disease [COPD], central sleep apnea syndromes, or hypoventilation

syndromes) (Option).

Treatment with PAP should ideally be approached on a case management basis utilizing a multidisciplinary care team

that can include a sleep specialist, the referring physician, nursing personnel, respiratory therapist, and sleep

technologist. Patients should be educated about the function, care, and maintenance of their equipment, the benefits

of PAP therapy, and potential problems. Patients, in conjunction with their care team, should work together to select

the most appropriate PAP interface. The nasal airway is the preferred delivery route; however, alternatives may be tried

to accommodate for comfort or difficulties (Consensus). The addition of heated humidification and a systematic

educational program is indicated to improve CPAP utilization (Standard). CPAP usage should be objectively monitored

with time meters to help assure utilization (Standard). CPAP and BPAP therapy are safe; side effects and adverse

events are mainly minor and reversible (Standard).

Close follow-up for PAP usage and problems by appropriately trained health care providers is indicated to establish

effective utilization patterns and remediate problems, if needed. This is especially important during the first few weeks

of PAP use (Standard). General OSA outcomes should be assessed in all patients (Consensus) (Table 6 in the

original guideline document). If CPAP use is considered inadequate based on objective monitoring and symptom

evaluation, prompt and intensive efforts should be implemented to improve PAP use or consider alternative therapies

(Consensus). After initial PAP setup, long-term follow-up by appropriately trained health care providers is indicated

yearly and as needed to troubleshoot PAP mask, machine, or usage problems (Option). The General Outcomes

assessment described above and in Table 6 of the original guideline document should be performed at follow-up visits.

Behavioral Strategies

Behavioral treatment options include weight loss, ideally to a body mass index (BMI) of 25 kg/m2 or less; exercise;

positional therapy; and avoidance of alcohol and sedatives before bedtime. Regardless of behavioral approach, general

OSA outcomes should be assessed after initiation of therapy in all patients (Consensus). The approach to initiation,

management, and follow-up of behavioral treatment is summarized in Figure 3 of the original guideline document.

Successful dietary weight loss may improve the AHI in obese patients with OSA (Guideline). Weight loss should be

recommended for all overweight OSA patients. Weight loss should be combined with a primary treatment for OSA

(Option) because of the low success rate of dietary programs and the low cure rate by dietary approach alone. After

substantial weight loss (i.e., 10% or more of body weight), a follow-up PSG is routinely indicated to ascertain whether

PAP therapy is still needed or whether adjustments in PAP level are necessary (Standard).

Sleep position can affect airway size and patency with a decrease in the area of the upper airway, particularly in the

lateral dimension, while in the supine position. Positional therapy, consisting of a method that keeps the patient in a

non-supine position, is an effective secondary therapy or can be a supplement to primary therapies for OSA in patients

who have a low AHI in the non-supine versus that in the supine position (Guideline). Because not all patients

normalize AHI when non-supine, correction of OSA by position should be documented with PSG before initiating this

form of treatment as a primary therapy (Consensus). A positioning device (e.g., alarm, pillow, backpack, tennis ball)

should be used when initiating positional therapy (Consensus). To establish the efficacy of a positioning device in the

home, providers should consider use of an objective position monitor (Consensus). Treatment-specific outcome

indicators to monitor with therapy include self-reported compliance, objective position monitoring, side effects, and

symptom resolution (Consensus).

Oral Appliances (OAs)

Custom made OAs may improve upper airway patency during sleep by enlarging the upper airway and/or by decreasing

upper airway collapsibility (e.g., improving upper airway muscle tone). Mandibular repositioning appliances (MRA) cover

the upper and lower teeth and hold the mandible in an advanced position with respect to the resting position. Tongue

retaining devices (TRD) hold only the tongue in a forward position with respect to the resting position, without

mandibular repositioning. An approach to initiation, management, and follow-up of patients using custom OA therapy is

summarized in Figure 4 in the original guideline document.

should be used when initiating positional therapy (Consensus). To establish the efficacy of a positioning device in the

home, providers should consider use of an objective position monitor (Consensus). Treatment-specific outcome

indicators to monitor with therapy include self-reported compliance, objective position monitoring, side effects, and

symptom resolution (Consensus).

Oral Appliances (OAs)

Custom made OAs may improve upper airway patency during sleep by enlarging the upper airway and/or by decreasing

upper airway collapsibility (e.g., improving upper airway muscle tone). Mandibular repositioning appliances (MRA) cover

the upper and lower teeth and hold the mandible in an advanced position with respect to the resting position. Tongue

retaining devices (TRD) hold only the tongue in a forward position with respect to the resting position, without

mandibular repositioning. An approach to initiation, management, and follow-up of patients using custom OA therapy is

summarized in Figure 4 in the original guideline document.

Although not as efficacious as CPAP, OAs are indicated for use in patients with mild to moderate OSA who prefer OAs

to CPAP, or who do not respond to CPAP, are not appropriate candidates for CPAP, or fail CPAP or behavioral measures

such as weight loss or sleep position change (Guideline). OAs are appropriate for use in patients with primary snoring

who do not respond to, or are not appropriate candidates for, treatment with behavioral measures such as weight loss

or sleep position change (Guideline). Patients with severe OSA should have an initial trial of nasal CPAP because

greater effectiveness has been shown with this intervention than with the use of OAs. Upper airway surgery (including

tonsillectomy and adenoidectomy, craniofacial operations, and tracheostomy) may also supersede use of OAs in

patients for whom these operations are predicted to be highly effective in treating sleep apnea (Guideline).

The presence or absence of OSA must be determined before initiating treatment with OAs to identify those patients at

risk due to complications of sleep apnea and to provide a baseline to establish the effectiveness of subsequent OA

treatment. The severity of sleep-related respiratory problems must be established in order to make an appropriate

treatment decision (Standard).

Patients should undergo a thorough dental examination to assess candidacy for an OA. The evaluation should include a

dental history and complete intra-oral examination. This examination includes a soft tissue, periodontal, and

temporomandibular joint (TMJ) assessment; an appraisal for characteristic patterns of wear from nocturnal bruxism;

and evaluation of occlusion. Dental records should be reviewed, and dental radiographs or a panorex survey may be

obtained to assess for possible dental pathology. Although a cephalometric evaluation is not always required for

patients who will use an OA, appropriately trained professionals should perform cephalometric examinations when they

are deemed necessary (Option). Oral appliances should be fitted by qualified dental personnel who are trained and

experienced in the overall care of oral health, the temporomandibular joint, dental occlusion, and associated oral

structures. Dental management of patients with OAs should be overseen by practitioners who have undertaken serious

training in sleep medicine and/or sleep-related breathing disorders with focused emphasis on the proper protocol for

diagnosis, treatment, and follow-up of OSA while using an OA (Option).

Candidates for a MRA require adequate healthy teeth upon which to seat the oral appliance, no important TMJ disorder,

adequate jaw range of motion, and adequate manual dexterity and motivation to insert and remove the OA, as

determined by a qualified dental professional (Consensus). TRDs may be used at any phase of treatment but may be

useful when the patient lacks the prerequisites for treatment with MRAs (Consensus). Intolerance and improper use of

the device are potential problems for patients using OAs, which require patient effort to use properly. OAs may

aggravate TMJ disease and may cause dental misalignment and discomfort that are unique to each device. In addition,

OAs can be rendered ineffective by patient alteration of the device (Option).

For patients with OSA, the desired outcome of treatment includes the resolution of the clinical signs and symptoms of

OSA and the normalization of the apnea-hypopnea index and oxyhemoglobin saturation (Standard). General OSA

outcomes should be assessed in all patients (Consensus) (see Table 6 in the original guideline document). OAs

should be monitored shortly after initiation of treatment and then as frequently as needed in order to assure patient

accommodation, comfort, adequate device titration, and adherence, and to assess symptoms and side effects

(Consensus). To ensure satisfactory therapeutic benefit from OAs, patients with OSA should undergo PSG or an

attended cardiorespiratory (type 3) sleep study with the OA in place after final adjustments of fit have been performed

(Guideline). Additionally, unattended PM may be indicated to monitor the response to non-CPAP treatments for OSA,

including OAs (Consensus). Once optimal fit is obtained and efficacy shown, follow-up with a dental specialist is

recommended every 6 months for the first year, and at least annually thereafter. The purpose of follow-up is to monitor

patient adherence, evaluate device deterioration or maladjustment, evaluate the health of the oral structures and

integrity of the occlusion, and assess the patient for signs and symptoms of worsening OSA. During all phases of

assessment, therapy, and follow-up, patients should have access to a care team with appropriate dental personnel,

educators, support groups, and sleep specialists (Consensus).

Surgical Treatment

The first methods used to treat OSA were surgical. Surgical therapy includes a variety of upper airway reconstructive or

bypass procedures, often site-directed and/or staged (Consensus). A list of common surgical procedures for OSA is

given in Table 7 of the original guideline document. The specifics of sleep apnea surgery are beyond the scope of this

guideline. A general approach to the management of OSA with surgical therapy is summarized in Figure 5 of the

original guideline document.

This guideline does not apply to surgical therapy for primary snoring.

The diagnosis of OSA should be established prior to surgery and the severity determined by objective testing

(Consensus). In addition to the general sleep evaluation described above, patients should be evaluated for eligibility

for surgery. This evaluation should include an anatomical examination to identify possible surgical sites; an

assessment of any medical, psychological, or social comorbidities that might affect surgical outcome; and a

determination of the patient’s desire for surgery (Consensus). The patient should be counseled on the surgical

options, likelihood of success, goals of treatment, risks and benefits of the procedure, possible side effects, and

complications and alternative treatments (Consensus).

Evaluation for primary surgical treatment can be considered in patients with mild OSA who have severe obstructing

anatomy that is surgically correctible (e.g., tonsillar hypertrophy obstructing the pharyngeal airway) (Consensus).

Surgical procedures may be considered as a secondary treatment for OSA when the outcome of PAP therapy is

inadequate, such as when the patient is intolerant of PAP, or PAP therapy is unable to eliminate OSA (Consensus).

Surgery may also be considered as a secondary therapy when there is an inadequate treatment outcome with an OA,

when the patient is intolerant of the OA, or the OA therapy provides unacceptable improvement of clinical outcomes of

OSA (Consensus). Surgery may also be considered as an adjunct therapy when obstructive anatomy or functional

deficiencies compromise other therapies or to improve tolerance of other OSA treatments (Consensus).

Tracheostomy can eliminate OSA but does not appropriately treat central hypoventilation syndromes (Consensus).

Maxillary and mandibular advancement can improve PSG parameters comparable to CPAP in the majority of patients

(Consensus). Most other sleep apnea surgeries are rarely curative for OSA but may improve clinical outcomes (e.g.,

mortality, cardiovascular risk, motor vehicle accidents, function, quality of life, and symptoms) (Consensus). Laserassisted

uvulopalatoplasty is not recommended for the treatment of obstructive sleep apnea (Guideline).

The frequency of post-surgical follow-up will be determined by the type of surgery but should include a surgery-specific

evaluation as well a general OSA-related evaluation. Surgery-specific outcomes to be evaluated by the surgical team

include wound healing, assessment of anatomical result, side effects, and complications (Consensus). For patients

undergoing multistep procedures, sleep specialist evaluation may be considered between surgeries for an intermediate

when the patient is intolerant of the OA, or the OA therapy provides unacceptable improvement of clinical outcomes of

OSA (Consensus). Surgery may also be considered as an adjunct therapy when obstructive anatomy or functional

deficiencies compromise other therapies or to improve tolerance of other OSA treatments (Consensus).

Tracheostomy can eliminate OSA but does not appropriately treat central hypoventilation syndromes (Consensus).

Maxillary and mandibular advancement can improve PSG parameters comparable to CPAP in the majority of patients

(Consensus). Most other sleep apnea surgeries are rarely curative for OSA but may improve clinical outcomes (e.g.,

mortality, cardiovascular risk, motor vehicle accidents, function, quality of life, and symptoms) (Consensus). Laserassisted

uvulopalatoplasty is not recommended for the treatment of obstructive sleep apnea (Guideline).

The frequency of post-surgical follow-up will be determined by the type of surgery but should include a surgery-specific

evaluation as well a general OSA-related evaluation. Surgery-specific outcomes to be evaluated by the surgical team

include wound healing, assessment of anatomical result, side effects, and complications (Consensus). For patients

undergoing multistep procedures, sleep specialist evaluation may be considered between surgeries for an intermediate

sleep study to assess response or reconsideration of all non-surgical therapies, if indicated. After the surgical team

determines healing is completed, a final general OSA outcome evaluation is indicated (Consensus) (see Table 6 in the

original guideline document). Sleep specialist follow-up is recommended for long-term follow-up after surgical

treatment is completed (Consensus). Following adjunctive surgery, patients should be evaluated to assess the effect

of surgery on PAP or OA tolerance, adherence, and symptom resolution (Consensus).

Adjunctive Therapies

Bariatric Surgery

Bariatric surgery is an effective means to achieve major weight loss and is indicated in individuals with a body mass

index (BMI) ≥40 kg/m2 or those with a BMI ≥35 kg/m2 with important comorbidities and in whom dietary attempts at

weight control have been ineffective. Bariatric surgery may be adjunctive in the treatment of OSA in obese patients

(Option). Bariatric surgery should be considered as an adjunct to less invasive and rapidly active first-line therapies

such as PAP for patients who have OSA and meet the currently published guidelines for bariatric surgery(Consensus).

The remission rate for OSA for two years after bariatric surgery, related to the amount of weight lost, is 40%,

emphasizing the need for ongoing clinical follow-up of these patients.

Pharmacologic Agents and Oxygen Therapy

There are no widely effective pharmacotherapies for OSA with the important exceptions of individuals with

hypothyroidism or acromegaly. Treatment of those underlying medical conditions can improve the AHI. Specifically,

selective serotonergic uptake inhibitors (SSRIs) (Standard), protriptyline (Guideline), methylxanthine derivatives

(aminophylline and theophylline) (Standard), and estrogen therapy (estrogen preparations with or without

progesterone) (Standard) are not recommended for the treatment of OSA. Short-acting nasal decongestants are not

recommended for treatment of OSA (Option), but topical nasal corticosteroids may improve the AHI in patients with

OSA and concurrent rhinitis, and thus may be a useful adjunct to primary therapies for OSA (Guideline).

Oxygen supplementation is not recommended as a primary treatment for OSA (Option). If supplemental oxygen is

used as an adjunct to other primary therapies to treat hypoxemia, follow-up must include documentation of resolution

of the hypoxemia (Consensus). Supplemental oxygen alone may reduce nocturnal hypoxemia but may also prolong

apneas and may potentially worsen nocturnal hypercapnia in patients with comorbid respiratory disease.

Modafinil is recommended for the treatment of residual excessive daytime sleepiness in OSA patients who have

sleepiness despite effective PAP treatment and who are lacking any other identifiable cause for their sleepiness

(Standard). Before using modafinil, other causes of residual sleepiness must be ruled out, including suboptimal

objective adherence with PAP; ill-fitting PAP masks; insufficient sleep; poor sleep hygiene; other sleep disorders such

as narcolepsy or restless legs syndrome/periodic limb movements of sleep; and depression. Modafinil should be used in

addition to PAP therapy. An approach to the management of OSA with adjunctive therapies is summarized in Figure 6

of the original guideline document.

Special Populations

In certain special populations the acceptance of routine care of OSA may be difficult and requires close discussion with

patients, families, and clinicians to formulate a well-tolerated care program. Patients with Down syndrome, Alzheimer

disease, and mental and physical handicaps may find any given therapy for OSA difficult. Clinical judgment is needed

to determine what degree of care for OSA is acceptable to the patient and achievable as a long-term care plan.

Long-term Management

All patients with OSA should have ongoing,