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## Complete Summary

#### GUIDELINE TITLE

Practice parameters for the medical therapy of obstructive sleep apnea.

#### BIBLIOGRAPHIC SOURCE(S)

Morgenthaler TI, Kapen S, Lee-Chiong T, Alessi C, Boehlecke B, Brown T,
Coleman J, Friedman L, Kapur V, Owens J, Pancer J, Swick T, Standards of
Practice Committee, American Academy of Sleep Medicine. Practice
parameters for the medical therapy of obstructive sleep apnea.
Sleep 2006 Aug 1;29(8):1031-5. \[65 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16944671)

#### 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.

-   [October 24, 2007, Provigil
    (modafinil)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Provigil):
    Cephalon has agreed to include additional labeling revisions to the
    WARNINGS, CLINICAL PHARMACOLOGY, PRECAUTIONS, and PATIENT PACKAGE
    INSERT sections.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 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)

-   Obstructive sleep apnea (OSA), including OSA related consequences:

    -   Excessive daytime sleepiness (EDS)

    -   Cognitive disturbances

    -   Depression

    -   Hypertension

    -   Cardiovascular disease

    -   Cerebrovascular disease

-   Obesity

#### GUIDELINE CATEGORY

Treatment

#### CLINICAL SPECIALTY

Internal Medicine\
Otolaryngology\
Pulmonary Medicine\
Sleep Medicine

#### INTENDED USERS

Advanced Practice Nurses\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide recommendations regarding the use of medical therapy (defined
as therapies other than modification of upper airway patency with
devices or surgical interventions) for the treatment of obstructive
sleep apnea (OSA)

#### TARGET POPULATION

Adults with obstructive sleep apnea

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Dietary weight loss

2.  Combination of dietary weight loss with primary treatment for
    obstructive sleep apnea (i.e., positive airway pressure, dental
    devices, surgery)

3.  Weight loss by bariatric surgery

4.  Treatment with modafinil

5.  Treatment with topical nasal corticosteroids

6.  Use of positional therapy

Note. The following interventions were considered by the authors, but
not recommended:

-   Selective serotonergic uptake inhibitors (ssris)

-   Protriptyline (not recommended as a primary treatment for OSA)

-   Methylxanthine derivatives (aminophylline and theophylline)

-   Estrogen therapy (estrogen preparations with or without
    progesterone)

-   Oxygen supplementation (not recommended as a primary treatment for
    OSA)

-   Short-acting nasal decongestants

#### MAJOR OUTCOMES CONSIDERED

-   Incidence of obstructive sleep apnea (OSA)

-   Apnea-hypoxia index (AHI)

-   Oxygen desaturation indices

-   Incidence and severity of excessive daytime sleepiness

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

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

Evidence was collected by the authors of the companion document, Medical
Therapy for Obstructive Sleep Apnea: A Review by the Medical Therapy for
Obstructive Sleep Apnea Task Force of the Standards of Practice
Committee of the American Academy of Sleep Medicine.

A PubMed search (<http://www.ncbi.nlm.nih.gov/entrez/query.fcgi>) was
conducted for key words: sleep apnea or obstructive sleep apnea with
bariatric surgery, diet, therapy, oxygen, supplemental oxygen, drug
therapy, pharmacotherapy, medical, endocrine, position, weight
reduction, weight loss, rhinitis, nasal symptoms, nasal therapy.
Literature searches were limited to clinical studies published in the
English language between 1985 and January 2005. A search update in April
2005 was conducted on PubMed for \"obstructive sleep apnea\" and
\"therapy\" with screening of abstracts to ensure completeness of
review. Inclusion criteria for the articles included: English language,
clinical trials, polysomnography end-points of apnea and/or hypopnea
indices and adult subjects. Exclusion criteria included case reports,
subjects \<20 years of age and use of non-United States Food and Drug
Administration-approved medications. In addition to reviewing pertinent
findings in the studies meeting the inclusion/exclusion criteria, the
authors of the companion document presented data from additional
studies, where further insight has been gained.

Of the 1750 abstracts identified by the key word search, 135 studies
were identified as qualifying for the above inclusion and exclusion
criteria and relevant to the categories of weight loss,
pharmacotherapies, delivery of supplemental oxygen and positional
therapy. Overall, most of the qualifying studies identified provided
Level II or Level III evidence for the effectiveness of an intervention
(see Rating Scheme for the Strength of the Evidence) on improving the
apnea-hypopnea index (AHI) Very few studies presented data on
neurobehavioral, metabolic or cardiovascular outcomes. In addition, very
few of the papers compare medical therapies to continuous positive
airway pressure (CPAP) outcomes.

#### 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

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%).

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

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

Studies described in this report have each been characterized with
evidence levels using criteria listed in Table 2 of the review paper
accompanying the original guideline document (see \"Availability of
Companion Documents\" field).

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

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

The Standards of Practice Committee of the American Academy of Sleep
Medicine (AASM) developed the recommendations based on the companion
document, Medical Therapy for Obstructive Sleep Apnea: A Review by the
Medical Therapy for Obstructive Sleep Apnea Task Force of the Standards
of Practice Committee of the American Academy of Sleep Medicine. A Task
Force of content experts was appointed by the AASM to review and grade
evidence in the scientific literature regarding therapies for
obstructive sleep apnea not covered by previous practice parameters.

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

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.

#### 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

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]{.underline}**:

**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

[References open in a new
window](http://www.guideline.gov/summary/select_ref.aspx?doc_id=9693)

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

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

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Decreased incidence and severity of obstructive sleep apnea (OSA) and
associated excessive daytime sleepiness, cognitive disturbances,
depression, hypertension, cardiovascular disease, and cerebrovascular
disease

#### POTENTIAL HARMS

-   Use of modafinil: Blood pressure must be monitored because of mild
    elevations reported in some obstructive sleep apnea (OSA) patients
    using modafinil.

-   Use of bariatric surgery: A cautionary note is warranted because of
    reports of recurrence of OSA after several years even without
    regaining of weight. Also, bariatric surgery is not without
    complications.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

These practice parameters define principles of practice that should meet
the needs of most patients in most situations. These guidelines should
not, however, 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 propriety of any specific
care must be made by the physician, in light of the individual
circumstances presented by the patient, available diagnostic tools,
accessible 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

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Morgenthaler TI, Kapen S, Lee-Chiong T, Alessi C, Boehlecke B, Brown T,
Coleman J, Friedman L, Kapur V, Owens J, Pancer J, Swick T, Standards of
Practice Committee, American Academy of Sleep Medicine. Practice
parameters for the medical therapy of obstructive sleep apnea.
Sleep 2006 Aug 1;29(8):1031-5. \[65 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16944671)

#### 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](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:

-   Veasey, SC, Guilleminault C, Strohl KP, Sanders, MH, Ballard RD,
    Magalang UJ. Medical therapy for obstructive sleep apnea: a review
    by the Medical Therapy for Obstructive Sleep Apnea Task Force of the
    Standards of Practice Committee of the American Academy of Sleep
    Medicine. Sleep 2006 Aug;29(8):1036-44.

Electronic copies: Available in Portable Document Format (PDF) from the
[American Academy of Sleep Medicine Web
site.](http://www.aasmnet.org/Resources/PracticeParameters/Review_MedicalTherapyOSA.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 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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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008