Diagnosis and Treatment of Obstructive Sleep Apnea in Adults

Diagnosis and Treatment of Obstructive Sleep Apnea in

AdultsPrepared for:

Agency for Healthcare Research and Quality (AHRQ)

www.ahrq.gov

Introduction to obstructive sleep apnea (OSA), diagnosis, and treatment.

Systematic review methods. The clinical questions addressed by the

comparative effectiveness review. Results of studies and evidence based conclusions

about the effectiveness and harms of OSA diagnosis and treatment.

Gaps in knowledge and future research needs. What to discuss with patients and their caregivers.

Outline of Material

Balk EM, Moorthy D, Obadan NO, et al. AHRQ Comparative Effectiveness Review No. 32. July 2011.Available at: http://www.effectivehealthcare.ahrq.gov/apnea.cfm.

Obstructive sleep apnea (OSA) involves repeated upper airway collapse during sleep.

This results in partial or complete cessation of breathing (hypopnea or apnea, respectively).

The frequency with which cessation of breathing occurs varies, but it can happen more than once each minute.

OSA symptoms include poor sleep quality, excessive sleeping, and daytime sleepiness.

Many people with OSA are asymptomatic.

Background: Characteristics of Obstructive Sleep Apnea


Victor LD. Am Fam Physician 1999;60:2279-86. PMID: 10593319.

Obstructive sleep apnea (OSA) is relatively common in the United States.

It is most prevalent among the middle-aged and elderly, although it affects people of all ages.

The prevalence of OSA appears to be high and has been reported to be 10%–20% among middle-aged and older adults.

The prevalence of OSA among those aged 65 years and older is believed to be higher.

Background: Epidemiology of Obstructive Sleep Apnea


Young T, Shahar E, Nieto FJ, et al. Arch Intern Med 2002;162:893-900. PMID: 11966340.

Increased risk for cardiovascular disease.

Cardiac disease. Hypertension. Stroke.

Increased risk for noninsulin dependent diabetes and other metabolic abnormalities.

Increased likelihood of motor vehicle and other accidents due to daytime sleepiness.

Increased risk for perioperative and postoperative complications.

Decreased quality of life. Decreased concentration.

Background: Adverse Clinical Outcomes Associated With Obstructive Sleep Apnea

Balk EM, Moorthy D, Obadan NO, et al. AHRQ Comparative Effectiveness Review No. 32. July 2011. Available at: http://www.effectivehealthcare.ahrq.gov/apnea.cfm.

Victor LD. Am Fam Physician 1999;60:2279-86. PMID: 10593319; Punjabi NM. Proc Am Thorac Soc 2008;5:136-143. PMID: 18250205; Nieto FJ, Young TB, Lind BK,et al. JAMA 2000;283:1829-1836. PMID: 10770144; Teran-Santos J, Jimenez-Gomez A, Cordero-Guevara J, and the Cooperative Group Burgos-Santander. N Engl J Med 1999;340:847-51. PMID: 10080847; Young T, Palta M, Dempsey J, et al. N Engl J Med 1993;328:1230-5. PMID: 8464434.

Background: Diagnosis of Obstructive Sleep Apnea (1 of 3)


Polysomnography (PSG) is the current diagnostic standard for obstructive sleep apnea.

Portable sleep monitors can be used in a hospital, home setting, or sleep unit.

Questionnaires and clinical prediction rules are also used in diagnosis and for case finding.



Polysomnography Task Force of the American Sleep Disorders Association Standards of Practice Committee. Sleep 1997;20:406-22. PMID: 9302725.

The apnea-hypopnea index (AHI) is used as a metric to diagnose obstructive sleep apnea (OSA) and to classify disease severity.

AHI = The number of apnea and hypopnea events per hour of sleep.

There is no current AHI threshold that indicates the need for treatment.

By consensus, individuals with few episodes of disordered breathing (often AHI <5 or <15 events per hour) are not formally diagnosed with OSA.

Individuals with frequent events (AHI ≥30 events/hr) are more likely to be at risk for adverse outcomes.



American Academy of Sleep Medicine. The International Classification of Sleep Disorders: diagnostic and coding manual. 2nd ed. 2005.

Epstein LJ, Kristo D, Strollo PJ Jr. et al, for the Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine.J Clin Sleep Med 2009;5:263-76. PMID: 19960649.

Continuous positive airway pressure machine Oral devices, most commonly mandibular

advancement device

Background: Treatment of Obstructive Sleep Apnea (1 of 2)


Surgery Weight loss Positional therapy Oropharyngeal exercises Nasal dilator strips Atrial overdrive pacing Acupuncture Auricular plaster therapy Drug therapies – ventilator stimulation, REM sleep

suppression

Background: Treatment of Obstructive Sleep Apnea (2 of 2)


The definition of obstructive sleep apnea (OSA) is inconsistent.

There is debate about the level of respiratory abnormality that defines the disorder.

There is also debate about the most appropriate approach to diagnose OSA.

Patient compliance is often a barrier to effective treatment.

Background: Challenges to Diagnosis and Treatment


Trikalinos TA, Ip S, Raman G, et al. Home Diagnosis of Obstructive Sleep Apnea-Hypopnea Syndrome. August 2007. Available at: http://www.cms.gov/determinationprocess/downloads/id48TA.pdf.

Parthasarathy S, Haynes PL, Budhiraja R, et al. J Clin Sleep Med 2006;2:133-42. PMID: 17557485.

Topics are nominated through a public process, which includes submissions from health care professionals, professional organizations, the private sector, policymakers, members of the public, and others.

A systematic review of all relevant clinical studies is conducted by independent researchers, funded by AHRQ, to synthesize the evidence in a report summarizing what is known and not known about the select clinical issue. The research questions and the results of the report are subject to expert input, peer review, and public comment.

The results of these reviews are summarized into Clinician Guides and Consumer Guides for use in decisionmaking and in discussions with patients. The Guides and the full report, with references for included and excluded studies, are available at www.effectivehealthcare.ahrq.gov.

Agency for Healthcare Research and Quality (AHRQ) Comparative Effectiveness Review (CER) Development

Key Question (KQ) 1: How do different available tests compare in their ability to diagnose OSA in adults with symptoms suggestive of disordered sleep? How do these tests compare in different subgroups of patients, based on: race, gender, body mass index (BMI), existing non-insulin dependent diabetes mellitus, existing cardiovascular disease, existing hypertension, clinical symptoms, previous stroke, or airway characteristics?

KQ2: How does phased testing (screening tests or battery followed by full test) compare to full testing alone?

KQ3: What is the effect of preoperative screening for OSA on surgical outcomes?

Clinical Questions Addressed by the CER (1 of 2)


Key Question (KQ) 4: In adults being screened for obstructive sleep apnea (OSA), what are the relationships between apnea-hypopnea index (AHI) or oxygen desaturation index, and other patient characteristics with long term clinical and functional outcomes?

KQ5: What is the comparative effect of different treatments for OSA in adults?

KQ6: In OSA patients prescribed nonsurgical treatments, what are the associations of pretreatment patient-level characteristics with treatment compliance?

KQ7: What is the effect of interventions to improve compliance with device use (positive airway pressure, oral appliances, positional therapy) on clinical and intermediate outcomes?

Clinical Questions Addressed by the CER (2 of 2)


The strength of evidence was classified into four broad categories:

Rating the Strength of Evidence From the CER


At-home monitors accurately predict elevated AHI suggestive of obstructive sleep apnea (OSA) (but cannot accurately estimate exact AHI values as measured by sleep-laboratory polysomnography): Type II monitors.

Strength of evidence: low Type III and IV monitors.

Strength of evidence: moderate

There is insufficient evidence to compare the different at-home monitors.

Effectiveness of Portable Devices and Polysomnography


The Berlin Questionnaire has high sensitivity and specificity in screening for obstructive sleep apnea (OSA).

Strength of evidence: low There is insufficient evidence to evaluate:

The commonly used STOP and STOP-Bang questionnaires. The effectiveness of most questionnaires in screening for

OSA.

Strength of evidence: insufficient Some clinical prediction rules (a morphometric model and

a pulmonary function data model) may have predictive capacity, but these tools have not been validated externally.

Strength of evidence: low

Effectiveness of Questionnaires and Clinical Prediction Rules


There is insufficient evidence to evaluate the effectiveness of phased testing for detection of obstructive sleep apnea (OSA).

Strength of evidence: insufficient

There is insufficient evidence to evaluate postoperative outcomes after mandatory preoperative screening for OSA.


Effectiveness of Phased Testing and Preoperative Screening


Severe obstructive sleep apnea (OSA) (AHI ≥30 events/hr) is a predictor of all-cause mortality (HR, 1.5–3.0).

Strength of evidence: high A high baseline AHI is correlated with diabetes (OR, 2.8–4.1).

Strength of evidence: low The strength of evidence is insufficient regarding the

association between AHI and other clinical outcomes.


Correlation of AHI with Health Outcomes

AHI: apnea-hypopnea index; HR: hazard ratio; OR: odds ratio.


Botros N, Concato J, Mohsenin V, et al. Am J Med 2009;122:1122-7. PMID: 19958890.

Reichmuth KJ, Austin D, Skatrud JB, et al. Am J Respir Crit Care Med 2005;172:1590-5. PMID: 16192452.

CPAP and MAD improve sleepiness and lower AHI values when compared to control treatments or no treatment.

Strength of evidence: moderate CPAP is superior to MAD in achieving an AHI of ≤5

events per hour.

Strength of evidence: moderate Evidence is insufficient to address which patients might

benefit most from treatment with CPAP, MAD, or CPAP compared to MAD.


Comparative Effectiveness of CPAP vs. MAD

CPAP = continuous positive airway pressure machine; MAD = mandibular advancement device.Balk EM, Moorthy D, Obadan NO, et al. AHRQ Comparative Effectiveness Review No. 32. July 2011.Available at: http://www.effectivehealthcare.ahrq.gov/apnea.cfm.

Meta-analysis of Apnea-hypopnea Index in RCTs of MAD Versus CPAP


Autotitrated continuous positive airway pressure machines (CPAP) and fixed CPAP are equally effective.

Strength of evidence: moderate Trials evaluating flexible CPAP (C-Flex) showed no statistically

significant differences in compliance or other outcomes versus CPAP.

Strength of evidence: low Evidence is insufficient to compare other CPAP devices (oral

CPAP, nasal CPAP, bilateral PAP, flexible bilateral PAP, and humidified CPAP or autoCPAP).


Comparative Effectiveness of Continuous Positive Airway Pressure Machines

*Current research evaluates only intermediate outcomes, so these findings may not apply to long-term clinical outcomes.


The studies for surgical interventions are limited, and current evidence is insufficient to determine their effectiveness when compared to sham, no treatment, or other obstructive sleep apnea (OSA) interventions.


Effectiveness of Surgical Interventions


Weight-loss programs may be an effective treatment for OSA (vs. control interventions) in patients who are obese.

Strength of evidence: low There is insufficient evidence to compare the effectiveness of

other treatments for OSA, such as drugs, implants, exercises, positional approaches, acupuncture, and nasal dilator strips.


Other Outcomes of Interest (1 of 2)


Compliance with OSA treatments:

High apnea-hypopnea index and Epworth sleepiness scale are predictors of improved CPAP compliance.

Strength of evidence: moderate Evidence is insufficient to evaluate potential

predictors of mandibular advancement device compliance.

Strength of evidence: insufficient Some specific adjunct interventions may improve

CPAP compliance, but studies are heterogeneous and no general type of intervention (e.g., education, telemonitoring) was more promising than others.

Strength of evidence: low

Other Outcomes of Interest (2 of 2)


Continuous positive airway pressure may be associated with the following adverse events:

claustrophobia, nasal and oral dryness (including nosebleeds), pressure discomfort, gum or lip soreness or pain, excessive salivation, skin irritation, nasal irritation and obstruction, aerophagia, abdominal distension, and chest wall discomfort.

Adverse Events: Continuous Positive Airway Pressure


Mandibular advancement devices may be associated with the following adverse events: sleep disruption, sensations of pressure in the mouth, mucosal erosions, excessive salivation, dental crown damage, loosening of teeth, and tooth, mouth, and jaw pain/damage.

Adverse Events: Mandibular Advancement Devices


Surgery Postsurgical complications

Infection, hemorrhage, nerve palsies, emergency surgical treatments, cardiovascular events, respiratory failure, rehospitalization, and death.

Long-term adverse events Speech or voice changes, difficulty swallowing, and

airway stenosis.

Weight-loss programs No reported long-term adverse events.

Adverse Events: Surgery and Weight Loss


A high apnea-hypopnea index (AHI) is associated with all-cause mortality and diabetes, so it is important to identify individuals with obstructive sleep apnea (OSA).

Portable monitors can predict a diagnosis of OSA, but additional studies are needed to prove their value compared with polysomnography.

Some questionnaires may be useful screening tools. Continuous positive airway pressure remains the most

effective treatment for OSA. Mandibular advancement devices also improve sleepiness

and reduce AHI.

In obese patients, weight-loss programs show promise as an effective treatment.

Conclusions (1 of 2)


There is insufficient evidence to evaluate the effectiveness of other treatment options, including surgery.

Compliance remains a barrier to continuous positive airway pressure treatment, but there is insufficient evidence to evaluate compliance with other treatment options.

Conclusions (2 of 2)


Current studies have not adequately evaluated long-term clinical outcomes.

There is insufficient clinical trial evidence to evaluate the effectiveness of many obstructive sleep apnea (OSA) treatments, including surgery.

No studies use subgroup analysis in evaluating the effectiveness of treatment.

Patient adherence is a major problem inhibiting the effectiveness of CPAP treatment, but the relative compliance rates with MAD or other treatment interventions have not been evaluated.

Knowledge Gaps andFuture Research Needs


The serious negative health outcomes associated with obstructive sleep apnea (OSA).

Evidence is lacking for many long-term outcomes; however, intermediate outcomes such as sleepiness and the number of episodes of apnea and hypopnea can be improved.

The diagnostic and screening tools available to test for and evaluate OSA status and severity.

The potential benefits and adverse events associated with CPAP, MAD, and other treatment options – including the importance of compliance.

Patient preferences regarding diagnosis and treatment.

What To Discuss With Your Patientsand Their Caregivers


Documents

Diagnosis and Treatment of Obstructive Sleep Apnea in Adults