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Brief Summary

GUIDELINE TITLE

Practice parameters for the medical therapy of obstructive sleep apnea.

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

This is the current release of the guideline.

** REGULATORY ALERT **

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

BRIEF SUMMARY CONTENT

 ** REGULATORY ALERT **
 RECOMMENDATIONS
 EVIDENCE SUPPORTING THE RECOMMENDATIONS
 IDENTIFYING INFORMATION AND AVAILABILITY
 DISCLAIMER

 Go to the Complete Summary

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

Each recommendation is rated based on the level of the recommendation. Definitions of the levels of the evidence (levels I-V) and levels of the recommendations (Standard, Guideline, Option) are presented at the end of the "Major Recommendations" field.

Weight Reduction

Successful dietary weight loss may improve the apnea-hypopnea index (AHI) in obese obstructive sleep apnea (OSA) patients. (Guideline)

This parameter is based on one Level I, one Level II, and 2 Level III papers.

Dietary weight loss should be combined with a primary treatment for OSA. (Kushida et al., 2005; Kushida et al., 2006; American Sleep Disorders Association, 1996) (Option)

Bariatric surgery may be adjunctive in the treatment of OSA in obese patients. (Option)

There are no Level I-III studies of bariatric surgery for OSA specifically. However, many non-randomized, uncontrolled investigations are now available, show improvements in AHI with weight loss, and therefore there is consensus among members of the Task Force and the Standards of Practice Committee that bariatric surgery may play a role in the treatment of morbidly obese OSA patients as an adjunct to less invasive and rapidly active first-line therapies such as positive airway pressure (PAP).

Pharmacologic Agents

Selective serotonergic uptake inhibitors (SSRIs) are not recommended for treatment of OSA. (Standard)

The above recommendation is derived from 2 Level II publications and one level V using paroxetine and fluoxetine.

Protriptyline is not recommended as a primary treatment for OSA. (Guideline)

Three Level II and one Level V papers form the basis of this recommendation.

Methylxanthine derivatives (aminophylline and theophylline) are not recommended for treatment of OSA. (Standard)

For this recommendation, there are 3 Level II publications, all of which report similar negative findings.

Estrogen therapy (estrogen preparations with or without progesterone) is not indicated for the treatment of OSA. (Standard)

This recommendation is based on the results of 4 Level I, 3 Level II, and one Level V publications.

Modafinil is recommended for the treatment of residual excessive daytime sleepiness in OSA patients who have sleepiness despite effective positive airway pressure (PAP) treatment and who are lacking any other identifiable cause for their sleepiness. (Standard)

All five studies included in the review (3 Level I, one Level II, and one Level V) attest to the partial effectiveness of modafinil in the management of residual sleepiness in patients with treated OSA who have no other identifiable reason for hypersomnolence.

Supplemental Oxygen

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

There are 2 Level II and 2 Level III studies that show oxygen administration improves oxygenation parameters in patients with OSA.

Medical Therapies Intended To Improve Nasal Patency

Short-acting nasal decongestants are not recommended for treatment of OSA. (Option)

One level II study showed little additive effect of oxymetazoline to positional therapy in improving AHI.

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)

This recommendation is based upon the results of one level I study that demonstrated an improvement in mean AHI from 20 to 12 events/hr using fluticasone nasal spray.

Positional Therapies

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)

Patients who normalize their AHI when they sleep in a nonsupine position tend to have less severe OSA, to be less obese, and to be younger. Three Level II studies form the basis for this practice parameter, one of which compared supine with an upright position.

Definitions:

American Academy of Sleep Medicine Classification of Evidence

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

Level II Randomized trials with high alpha and beta levels*

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 80-90%).

American Academy of Sleep Medicine 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 overwhelming 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.

CLINICAL ALGORITHM(S)

None provided

EVIDENCE SUPPORTING THE RECOMMENDATIONS

REFERENCES SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each recommendation (see "Major Recommendations" field).

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

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

DATE RELEASED

2006 Aug 1

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: Timothy I. Morgenthaler, MD, Mayo Clinic, Rochester, MN; Sheldon Kapen, MD, Detroit VA Medical Center, Detroit, MI; Teofilo Lee-Chiong, MD, National Jewish Medical and Research Center, Denver, CO; Cathy Alessi, MD, UCLA/Greater Los Angeles VA Healthcare System, Sepulveda, CA; Brian Boehlecke, MD, University of North Carolina, Chapel Hill, NC; Terry Brown, DO, St. Joseph Memorial Hospital, Murphysboro, IL; Jack Coleman, MD, Murfreesboro, TN; Leah Friedman, MA, PhD, Stanford University, Stanford, CA; Vishesh Kapur, MD, University of Washington, Seattle, WA; Judith Owens, MD, Rhode Island Hospital, Providence, RI; Jeffrey Pancer, DDS, Toronto, Ontario, Canada; Todd Swick, MD, Houston Sleep Center, Houston, TX

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

This was not an industry supported study. Dr. Morgenthaler has received research support from Itamar Medical Ltd. and ResMed Research Foundation; and has received research equipment from Olympus. Dr. Alessi is a consultant for Prescription Solutions, Inc. Dr. Coleman is a member of the Medical Advisory Board for Influent and is a consultant and speaker/instructor for Acclarent. Dr. Kapur has received research support from Pro-tech Services, Inc.; and has received research equipment from Respironics. Dr. Owens has received research support from Eli Lilly, Cephalon, and Sepracor; is a consultant for Eli Lilly, Cephalon, Shire, and Sanofi-Aventis; and has participated in speaking engagements supported by Eli Lilly, Cephalon, Sanofi-Aventis, and Johnson & Johnson. Dr. Swick has received research support from Sanofi- Aventis, Takeda Pharmaceuticals, Merck, Jazz Pharmaceuticals, Pfizer, Somaxon, Astellas-Pharmaceuticals, and Cephalon; and is on the speakers' bureau of GlaxoSmithKline, Jazz Pharmaceuticals, Sepracor, Cephalon, and Boehringer Ingelheim. Dr. Hirshkowitz has received research support from Sanofi-Aventis, Takeda, Merck, GlaxoSmithKline, Cephalon, Sepracor, Respironics, ResMed, and NBI; is on the speakers' bureau of Sanofi, Takeda, and Cephalon; is a consultant for Sanofi-Synthelabo, Takeda, and Cephalon; and has received research equipment from ResMed, Respironics, Sunrise, Puritan Bennett, Itamar, Nasal Aire, and Fisher-Paykel. Drs. Kapen, Lee-Chiong, Boehlecke, Brown, Friedman, and Pancer 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.

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.

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on September 22, 2006. This summary was updated by ECRI Institute on November 6, 2007, following the U.S. Food and Drug Administration advisory on Provigil (modafinil) Tablets.

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.

DISCLAIMER

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