Understanding the Sleep Apnea/Insomnia Interaction

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes; Sleep Initiation and Maintenance Disorders
• Interventions: Device: CPAP; Device: sham CPAP; Behavioral: CC; Behavioral: CBT

• Registration Number: NCT01824472
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-01
• Study First Submitted QC: 2013-04-01
• Study First Posted: 2013-04-04
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Results First Submitted: 2020-02-10
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Results First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Sleep Apnea
2. Insomnia
3. Age >18

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Exclusion Criteria

1. Sedative/psychoactive drug use recently
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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP+CC	CC	Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP+CC	CC	sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP+CC	CPAP	Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia)
sham CPAP+CC	sham CPAP	sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
CPAP+CBT	CPAP	CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia
CPAP+CBT	CBT	CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index Score	Between Baseline and Day 42.	Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.

Trial Locations

Locations (1)

University of Pennsylvania Health System; 🇺🇸 Philadelphia, Pennsylvania, United States