Final Research Plan
Obstructive Sleep Apnea in Adults: Screening
March 04, 2021
Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.
Abbreviations: AHI=apnea-hypopnea index; OSA=obstructive sleep apnea.
- Does screening for obstructive sleep apnea (OSA) in adults improve health outcomes, including for specific subgroups of interest?
- What is the accuracy of screening questionnaires, clinical prediction tools, and multistep screening approaches (e.g., using a questionnaire followed by home-based oximetry/testing) in identifying persons in the general population who are more or less likely to have OSA, including for specific subgroups of interest?
- What are the harms associated with screening or subsequent diagnostic testing for OSA, including for specific subgroups of interest?
- How effective is treatment with positive airway pressure (PAP) or mandibular advancement devices (MADs) for improving intermediate outcomes (i.e., the apnea-hypopnea index [AHI] or blood pressure) in persons with OSA, including for specific subgroups of interest?
- How effective is treatment with PAP or MADs for improving health outcomes in persons with OSA, including for specific subgroups of interest?
- What are the harms associated with treatment of OSA using PAP or MADs, including for specific subgroups of interest?
Contextual Questions will not be systematically reviewed and are not shown in the Analytic Framework.
- What are the barriers to undergoing diagnostic testing for OSA (e.g., availability of polysomnography, ability to tolerate testing)? How often do those barriers prevent completion of testing?
- Is there an association between AHI and health outcomes?
The Research Approach identifies the study characteristics and criteria that the Evidence-based Practice Center will use to search for publications and to determine whether identified studies should be included or excluded from the Evidence Review. Criteria are overarching as well as specific to each of the Key Questions.
|Populations||KQs 1–3: Adults age 18 years or older who are asymptomatic or have unrecognized symptoms of OSA
KQs 4–6: Persons with a confirmed diagnosis of OSA; population may include asymptomatic or symptomatic adults
All KQs: A priori subgroups of interest include those defined by age, sex, BMI category, and OSA severity*
|All KQs: Children and adolescents; pregnant women; studies of adults with acute stroke or other acute conditions that can trigger onset of OSA; studies focused on screening, diagnosis, or treatment of OSA among persons with a rare condition (e.g., acromegaly)
KQs 4–6: Studies of persons with suspected but unconfirmed OSA
|Setting||Studies conducted in countries categorized as “Very High” on the Human Development Index, as defined by the United Nations Development Programme||KQs 1-3: Populations screened for OSA in perioperative settings or screened in the context of occupational health examination to determine fitness for duty
KQs 4-6: Interventions studied only in laboratories (e.g., studies of PAP conducted in sleep laboratories)
|Screening||Externally validated questionnaires, including the ESS, STOP Questionnaire, Berlin Questionnaire, Wisconsin Sleep Questionnaire, or STOP-BANG Questionnaire; externally validated risk stratification or clinical prediction tools that include multiple factors (e.g., the Multivariable Apnea Prediction Index); may include findings from physical examination (e.g., neck circumference, Mallampati classification); combined screening approaches are also eligible, which may use a questionnaire or clinical prediction tool followed by home-based oximetry testing for persons who score above a defined threshold on the questionnaire or clinical prediction tool||Studies assessing single patient characteristics or risk factors|
|Treatment||Interventions appropriate for screen-detected or newly detected OSA, including PAP and MADs; variations of PAP are eligible, including continuous, auto-titrating and bilevel, with different device interfaces (e.g., nasal and oronasal masks) and accessory features such as humidification||All other interventions for OSA, including surgery, atrial overdrive pacing, medications, palatal implants, oropharyngeal exercises, tongue-retaining devices, positional alarms, nasal dilator strips, acupuncture, and auricular plaster; medications to treat sleepiness, sleep quality, or bruxism (rather than used to treat OSA), such as eszopiclone and modafinil; nasal steroids for treatment of allergic rhinitis or similar treatments that might secondarily improve OSA by treating another condition|
|Comparisons||KQs 1, 3: Screened vs. nonscreened groups or groups undergoing screening, diagnostic testing, or both vs. groups not undergoing screening, diagnostic testing, or both
KQ 2: Studies on accuracy of screening must include a comparison with overnight PSG conducted in a sleep laboratory; studies may also determine or compare persons at increased, average, or decreased risk or persons at higher and lower risk for OSA
|All KQs: No comparison; nonconcordant historical controls; comparative studies of various interventions (e.g., comparing PAP with MADs or comparing different types of PAP)
KQ 2: Studies with verification bias in which only a subgroup had PSG as the comparator
|Outcomes||KQs 1, 5: Mortality, quality of life (both disease-specific measures, such as the Functional Outcomes of Sleep Questionnaire, and general measures, such as the 36-Item Short-Form Health Survey), measures of sleepiness, motor vehicle crashes, cardiovascular events (including ischemic events and rhythm disturbances, such as incident atrial fibrillation), cerebrovascular events, incidence of heart failure, headaches, and cognitive impairment
KQ 2: Sensitivity, specificity, discrimination, and calibration
|All other outcomes
KQ 2: Acceptability of screening
|Study designs||KQs 1, 5-6: RCTs
KQ 2: Prospective cohort studies and cross-sectional studies that develop or evaluate screening questionnaires, clinical prediction tools, or combined screening approaches
|All other study designs
KQ 2: Questionnaires, tools, and tests not validated in a group of participants separate from the sample used to develop the test
|Language||English||Languages other than English|
|Study quality||Good or fair||Poor (according to design-specific USPSTF criteria)|
* OSA severity will be defined as mild if the AHI (or RDI) is ≥5 to <15, moderate if the AHI (or RDI) is ≥15 to ≤30, and severe if the AHI (or RDI) is ≥30.
Abbreviations: AHI=apnea-hypopnea index; BMI=body mass index; ESS=Epworth Sleepiness Scale; KQ=key question; MAD=mandibular advancement device; OSA=obstructive sleep apnea; PAP=positive airway pressure; PSG=polysomnography; RCT=randomized, controlled trial; RDI=Respiratory Disturbance Index; STOP-Bang=snoring, tiredness, observed apnea, high blood pressure, BMI, age, neck circumference, and male gender; USPSTF=U.S. Preventive Services Task Force.
The draft Research Plan was posted on the U.S. Preventive Services Task Force website for public comment from December 17, 2020, to January 20, 2021. In response to public comments, the USPSTF revised the treatment eligibility criteria to clarify the variations of PAP that are eligible and that studies focused on screening specific occupational groups in the context of an occupational health examination for fitness for duty are excluded. The USPSTF made no substantive changes that altered the scope of the review.