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## Complete Summary

#### GUIDELINE TITLE

Practice parameters for the use of continuous and bilevel positive
airway pressure devices to treat adult patients with sleep-related
breathing disorders.

#### BIBLIOGRAPHIC SOURCE(S)

Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA,
Bailey D, Boehlecke B, Brown TM, Coleman J Jr, Friedman L, Kapen S,
Kapur VK, Kramer M, Lee-Chiong T, Owens J, Pancer JP, Swick TJ, Wise MS,
American Academy of Sleep Medicine. Practice parameters for the use of
continuous and bilevel positive airway pressure devices to treat adult
patients with sleep-related breathing disorders. Sleep 2006 Mar
1;29(3):375-80. \[94 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16553024)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Sleep-related breathing disorders including obstructive sleep apnea
(OSA)

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Evaluation\
Treatment

#### CLINICAL SPECIALTY

Critical Care\
Internal Medicine\
Neurology\
Psychiatry\
Pulmonary Medicine\
Sleep Medicine

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

-   To provide practice parameters for the use of continuous and bilevel
    positive airway pressure devices to treat adult patients with
    sleep-related breathing disorders

-   To provide recommendations that add to the previously published
    guidelines and practice parameters on the diagnosis and management
    of obstructive sleep apnea (OSA)

#### TARGET POPULATION

Adults with sleep-related breathing disorders including obstructive
sleep apnea (OSA)

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Treatment based on prior diagnosis of obstructive sleep apnea using
    appropriate standards

2.  Continuous positive airway pressure (CPAP) treatment

3.  Bi-level positive airway pressure (BPAP) treatment

4.  Addition of heated humidification and usage monitors

5.  Polysomnography for titration (full-night or split-night, diagnostic
    titration studies)

6.  Follow-up for usage and problems with devices

7.  Patient education programs

#### MAJOR OUTCOMES CONSIDERED

-   Clinical signs and symptoms of obstructive sleep apnea OSA

-   Quality of life

-   Optimal positive airway pressure (PAP)

-   PAP utilization

-   Daytime hypercapnea

-   Adverse events

-   Patient compliance/adherence

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Searches in the English language literature (Medline 1966 - early 2005)
of major topics relevant to positive airway pressure (PAP) treatment
during sleep-related breathing disorders (SRBDs) were conducted. The
initial literature search was done in April of 2001 followed by an
update in April of 2002. A final literature search for just Level I
studies was done in January of 2005 in order to keep the review as
timely as possible and to avoid omission of potentially high impact
studies published in the interim. The decision to limit the final search
and some entire sections to Level I or II evidence was decided upon by
the Task Force for the purposes of simplification and brevity. The Task
Force did not feel this would detract from the overall conclusions made
within the body of this review. The search focused on peer-reviewed
clinical studies, including case-series and controlled trials, which
contained information regarding PAP treatment outcomes, methods for
polysomnographic titration, factors affecting adherence and side
effects. Major search terms are included as Table 2 in the accompanying
review paper (see the \"Availability of Companion Documents\" field).
Review papers, commentary, case reports, pediatric populations, and
studies pertaining to automatic adjusting positive airway pressure
(APAP) were excluded, except where parenthetical comments are
specifically noted.

#### 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

**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 error refers to the probability (generally set at 95% or
greater) that a significant outcome (e.g., p\<0.05) is not a result of
chance occurrence. Beta error refers to the probability (generally set
at 80% to 90% or greater) that a nonsignificant result (e.g., p\>0.05)
is the correct conclusion of the study or studies. The estimation of
beta error is generally the result of a power analysis. The power
analysis includes a sample size analysis to project the size of the
study population necessary to ensure that significant differences will
be observed if actually present.

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The level of evidence for the data in each paper relevant to the
evaluation is listed in evidence tables specific for each question. Each
paper was analyzed independently by 2 task force members. The level of
evidence was rated using the American Academy of Sleep Medicine (AASM)
classification of evidence for intervention studies, an adaptation of
the Sackett criteria (See Rating Scheme for the Strength of the Evidence
field in this summary). Disagreements between the 2 raters were
adjudicated by a vote of the task force members.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The Standards of Practice Committee (SPC) of the American Academy of
Sleep Medicine (AASM) reviewed the accompanying review (see the
\"Availability of Companion Documents\" field) and cited literature to
develop the recommendations. These recommendations pertain to adults and
in most cases are based on evidence published in peer-reviewed journals.
However, where scientific data are absent, insufficient, or
inconclusive, recommendations are based upon committee consensus.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Levels of Recommendation**

**Standard**: This is a generally accepted patient-care strategy, which
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 over whelming Level II Evidence.

**Guideline**: This is a patient-care strategy, which 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, which reflects uncertain
clinical use. The term option implies either inconclusive or conflicting
evidence or conflicting expert opinion.

#### COST ANALYSIS

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

#### METHOD OF GUIDELINE VALIDATION

External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

An outside review of these recommendations was performed and the
American Academy of Sleep Medicine Board of Directors affirmed approval.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Levels of recommendation (Standard, Guideline, Option) and levels of
evidence (I-IV) are defined at the end of the \"Major Recommendations\"
field

Treatment with continuous positive airway pressure (CPAP) must be based
on a prior diagnosis of obstructive sleep apnea (OSA) established using
an acceptable method **(Standard**).

*This recommendation is based on previous American Academy of Sleep
Medicine (AASM) practice parameters for the indications for
polysomnography and related procedures (2005 update).*

CPAP is indicated for the treatment of moderate to severe OSA
**(Standard)**.

*This recommendation is based on 24 randomized controlled trials meeting
Level I or II evidence-based medicine criteria.*

CPAP is recommended for the treatment of mild OSA **(Option)**.

*This recommendation as an option is based on mixed results in 2 Level I
and 3 Level II outcome studies in patients with mild OSA.*

CPAP is indicated for improving self-reported sleepiness in patients
with OSA **(Standard)**.

*This recommendation is based on 10 randomized controlled trials in
which CPAP reduced sleepiness more than control procedures in patients
with OSA.*

CPAP is recommended for improving quality of life in patients with OSA
**(Option)**.

*This recommendation as an option is based on inconsistent results from
2 Level I studies and 4 Level II studies with placebo control, and 1
Level II study with conservative therapy as the control.*

CPAP is recommended as an adjunctive therapy to lower blood pressure in
hypertensive patients with OSA **(Option)**.

*This recommendation as an option is based on 9 clinical trials, 6 of
which did not find changes in mean arterial pressure compared to
placebo.*

Full-night, attended polysomnography performed in the laboratory is the
preferred approach for titration to determine optimal positive airway
pressure; however, split-night, diagnostic-titration studies are usually
adequate **(Guideline)**.

*This recommendation is based on 1 Level II and 6 Level IV studies.*

CPAP Usage should be objectively monitored to help assure utilization
**(Standard)**.

*This recommendation is based on overwhelming evidence at all levels
indicating patients with OSA overestimate their positive airway
pressure. Level I and Level II studies indicate that
objectively-measured nightly CPAP \"time on\" ranges from 3.5
hours/night in minimally symptomatic new patients to 7.1 hours/night in
established users.*

Close follow-up for positive airway pressure (PAP) usage and problems in
patients with OSA 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)**.

*This recommendation is based on 61 studies that examined management
paradigms and collected acceptance, utilization, and adverse events; 17
of these studies qualified as Level I.*

The addition of heated humidification is indicated to improve CPAP
utilization **(Standard)**.

*This recommendation is based on 3 Level I studies. There was 1 Level II
study that did not find increased utilization with heated
humidification. Three additional studies favored heated humidification
over unheated or non-humidified CPAP.*

The addition of a systematic educational program is indicated to improve
PAP utilization **(Standard)**.

*This recommendation is based on 4 Level I studies, 1 Level II study,
and 1 Level III study.*

After initial CPAP setup, long-term follow-up for CPAP-treated patients
with OSA by appropriately trained health care providers is indicated
yearly and as needed to troubleshoot PAP mask, machine, or usage
problems **(Option)**.

*This recommendation as an option is based on task force and SPC member
consensus.*

CPAP and bi-level positive airway pressure (BPAP) therapy are safe; side
effects and adverse events are mainly minor and reversible
**(Standard)**.

*This recommendation is based on more than 23 published reports.*

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)**.

*This recommendation is based on 2 Level I studies which yielded no
evidence that BPAP improves efficacy or adherence in the management of
OSA compared to CPAP.*

BPAP may be useful in treating some forms of restrictive lung disease or
hypoventilation syndromes associated with daytime hypercapnia
**(Option)**.

*This recommendation as an option is based on 11 studies all graded at
Level III or better that overall found improvement associated with BPAP
therapy.*

**[Definitions]{.underline}**:

**Levels of Recommendations**

**Standard**: This is a generally accepted patient-care strategy, which
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 over whelming Level II Evidence.

**Guideline**: This is a patient-care strategy, which 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, which reflects uncertain
clinical use. The term option implies either inconclusive or conflicting
evidence or conflicting expert opinion.

**Classification of Evidence**

**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 error refers to the probability (generally set at 95% or
greater) that a significant outcome (e.g., p\<0.05) is not a result of
chance occurrence. Beta error refers to the probability (generally set
at 80% to 90% or greater) that a nonsignificant result (e.g., p\>0.05)
is the correct conclusion of the study or studies. The estimation of
beta error is generally the result of a power analysis. The power
analysis includes a sample size analysis to project the size of the
study population necessary to ensure that significant differences will
be observed if actually present.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for the
recommendations (See \"Major Recommendations\"). These recommendations,
in most cases, are based on evidence published in peer-reviewed
journals. However, where scientific data are absent, insufficient, or
inconclusive, recommendations are based upon committee consensus.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Increased correct patient utilization of positive airway pressure
    (PAP) devices

-   Improved clinical management of obstructive sleep apnea (OSA)

-   Identification of appropriate indications for bilevel positive
    airway pressure (BPAP) as a second-line therapy

#### POTENTIAL HARMS

While sinusitis, mask leaks, and dermatitis are not infrequent, tinnitus
and dyspnea occur more rarely. A listing of adverse events associated
with positive airway pressure (PAP) therapy is presented in Table 3 of
the accompanying review paper (see \"Availability of Companion
Documents\" field).

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

These guidelines should not be considered inclusive of all proper
methods of care or exclusive of other methods of care reasonably
directed to obtaining the same results. The ultimate judgment regarding
the propriety of any specific care must be made by the clinician in
light of the individual circumstances presented by the patient and the
availability of diagnostic and treatment options and resources.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Kushida CA, Littner MR, Hirshkowitz M, Morgenthaler TI, Alessi CA,
Bailey D, Boehlecke B, Brown TM, Coleman J Jr, Friedman L, Kapen S,
Kapur VK, Kramer M, Lee-Chiong T, Owens J, Pancer JP, Swick TJ, Wise MS,
American Academy of Sleep Medicine. Practice parameters for the use of
continuous and bilevel positive airway pressure devices to treat adult
patients with sleep-related breathing disorders. Sleep 2006 Mar
1;29(3):375-80. \[94 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16553024)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2006 Mar

#### GUIDELINE DEVELOPER(S)

American Academy of Sleep Medicine - Professional Association

#### SOURCE(S) OF FUNDING

American Academy of Sleep Medicine

#### GUIDELINE COMMITTEE

Standards of Practice Committee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Committee Members*: Clete A. Kushida, MD, PhD, Stanford University
Center of Excellence for Sleep Disorders, Stanford, CA; Michael R.
Littner, MD, VA Greater Los Angeles Healthcare System and David Geffen
School of Medicine at UCLA, Sepulveda, CA; Max Hirshkowitz, PhD, Baylor
College of Medicine and VA Medical Center, Houston, TX; Timothy I.
Morgenthaler, MD, Mayo Sleep Disorders Center, Mayo Clinic, Rochester,
MN; Cathy A. Alessi, MD, UCLA/Greater Los Angeles Healthcare System,
Sepulveda, CA; Dennis Bailey, DDS, Englewood, Colorado; Brian Boehlecke,
MD, MSPH, University of North Carolina, Chapel Hill, NC; Terry M. Brown,
DO, St. Joseph Memorial Hospital, Murphysboro, IL; Jack Coleman, Jr.,
MD, Middle Tennessee ENT, Murfreesboro, TN; Leah Friedman, PhD, Stanford
University School of Medicine, Stanford, CA; Sheldon Kapen, MD, VA
Medical Center and Wayne State University, Detroit, MI; Vishesh K.
Kapur, MD, MPH, University of Washington Sleep Disorder Center, Seattle,
WA; Milton Kramer, MD, Maimoides Medical Center, Psychiatry Department,
Brooklyn, NY and New York University School of Medicine, New York, NY;
Teofilo Lee-Chiong, MD, National Jewish Medical and Research Center,
Sleep Clinic, Denver, CO; Judith Owens, MD, Department of Pediatrics,
Rhode Island Hospital, Providence, RI; Jeffrey P. Pancer, DDS, Toronto,
Ontario, CN; Todd J. Swick, MD, Houston, TX; Merrill S. Wise, MD,
Houston, TX

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

This was not an industry supported study. Dr. Kushida has received
research support from GlaxoSmithKline, Boehringer-Ingelheim, XenoPort,
Inc., Schwarz Pharmaceuticals, and Kyowa Pharmaceuticals; and has
participated in speaking engagements supported by GlaxoSmithKline. Dr.
Littner has received research support from GlaxoSmithKline, AstraZeneca,
Boehringer-Ingelheim, Dey Pharmaceuticals, and Altana Pharmaceuticals;
has participated in speaking engagements supported by Pfizer,
Glaxo-SmithKline, and Boehringer-Ingelheim; and is a member of the
advisory boards for Novartis, Pfizer, and Dey Pharmaceuticals. Dr.
Hirshkowitz has received research support from Sanofi, Merck, Takeda,
Somaxon, and Cephalon; is on the speakers\' bureaus for Cephalon,
Sanofi, Takeda, and Sepracor; and has received research equipment from
ResMed, Respironics, and Sunrise. Dr. Morgenthaler has received research
support from Itamar Medical, ResMed, and ResMed Research Foundation; and
has received research equipment from Olympus, Inc. Dr. Alessi is a
consultant for Prescription Solutions, Inc. Dr. Kapur has received
research support from the Washington Technology Center and Pro-tech
Services, Inc.; and has received research equipment from Respironics.
Dr. Owens has received research support from Eli Lilly, Cephalon,
Sepracor, and Johnson & Johnson; and is a speaker or consultant for Eli
Lilly, Cephalon, Johnson & Johnson, Shire, and Select Comfort. Dr. Swick
has received research support from Orphan Medical (Jazz
Pharmaceuticals), Cephalon, Sanofi-Aventis, Merck, and Takeda
Pharmaceuticals; and has participated in speaking engagements supported
by Orphan Medical (Jazz Pharmaceuticals), Cephalon, Takeda
Pharmaceuticals, and GlaxoSmithKline. Dr. Coleman has participated in
speaking engagements supported by Aventis; and is an investor in the
Murphysboro Imaging Leasing Company. Drs. Bailey, Boehlecke, Brown,
Friedman, Kapen, Kramer, Lee-Chiong, Pancer, and Wise have indicated no
financial conflicts of interest.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the
[American Academy of Sleep Medicine (AASM) Web
site](http://www.aasmnet.org/PracticeParameters.aspx).

Print copies: Available from the Standards of Practice Committee,
American Academy of Sleep Medicine, One Westbrook Corporate Center,
Suite 920, Westchester, IL 60154. Web site:
[www.aasmnet.org](http://www.aasmnet.org/).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   Gay P, Weaver T, Loube D, Iber C; Positive Airway Pressure Task
    Force of the Standards of Practice Committee of the American Academy
    of Sleep Medicine. Evaluation of positive airway pressure treatment
    for sleep related breathing disorders in adults. Sleep 2006
    Mar;29(3):381-401.

Electronic copies: Available in Portable Document Format (PDF) from the
[American Academy of Sleep Medicine Web
site](http://www.aasmnet.org/Resources/PracticeParameters/Review_PositiveAirwayPressure.pdf).

Print copies: Available from the Standards of Practice Committee,
American Academy of Sleep Medicine, One Westbrook Corporate Center,
Suite 920, Westchester, IL 60154. Web site:
[www.aasmnet.org](http://www.aasmnet.org/).

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on May 23, 2006.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please contact the
American Academy of Sleep Medicine (AASM) for information regarding
reproduction of AASM guidelines.

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Date Modified: 11/10/2008