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Sleep Apnea Syndromes | Understanding the Sleep Apnea/Insomnia Interaction

Sleep Apnea Syndromes research study

What is the primary objective of this study?

Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.

Who is eligible to participate?

Inclusion Criteria: 1. Sleep Apnea 2. Insomnia 3. Age >18 Exclusion Criteria: 1. Sedative/psychoactive drug use recently 2. Other clinically significant sleep disorders 3. Previous treatment for OSA 4. Requires oxygen or bilevel PAP therapy 5. Clinically unstable medical condition 6. Recent shift work 7. Significant alcohol use 8. Other clinically significant causes of insomnia 9. Illicit drug use 10. Prescription stimulants 11. Safety restrictions 12. Unable to treat sleep apnea with positive airway pressure therapy 13. Communication barriers 14. Cognitive impairment

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Sleep Apnea Syndromes

Sleep Initiation and Maintenance Disorders

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:CPAPTreatment for sleep apnea

Behavioral:CBTTreatment for insomnia

Device:sham CPAPPlacebo for sleep apnea

Behavioral:CCPlacebo (sham) for insomnia

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CPAP+CCCPAP therapy for sleep apnea and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)

sham CPAP+CCsham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)

CPAP+CBTCPAP therapy for sleep apnea and cognitive-behavioral therapy for insomnia

Study Status

Completed

Start Date: March 2013

Completed Date: March 2017

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Insomnia Severity Index Score

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator:

Lead Sponsor: University of Pennsylvania

Collaborator: National Heart, Lung, and Blood Institute (NHLBI)

More information:https://clinicaltrials.gov/show/NCT01824472

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