Study Results
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View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2013-03-31
2017-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CPAP+CC
Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP
Treatment for sleep apnea
CC
Placebo (sham) for insomnia
sham CPAP+CC
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP
Placebo for sleep apnea
CC
Placebo (sham) for insomnia
CPAP+CBT
CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia
CPAP
Treatment for sleep apnea
CBT
Treatment for insomnia
Interventions
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CPAP
Treatment for sleep apnea
CBT
Treatment for insomnia
sham CPAP
Placebo for sleep apnea
CC
Placebo (sham) for insomnia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Insomnia
3. Age \>18
Exclusion Criteria
2. Other clinically significant sleep disorders
3. Previous treatment for obstructive sleep apnea (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
18 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Pennsylvania
OTHER
Responsible Party
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Locations
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University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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814153
Identifier Type: -
Identifier Source: org_study_id
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