Understanding the Sleep Apnea/Insomnia Interaction

NCT ID: NCT01824472

Last Updated: 2020-08-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-03-31

Brief Summary

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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

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Conditions

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Sleep Apnea Syndromes Sleep Initiation and Maintenance Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

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)

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Treatment for sleep apnea

CC

Intervention Type BEHAVIORAL

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)

Group Type SHAM_COMPARATOR

sham CPAP

Intervention Type DEVICE

Placebo for sleep apnea

CC

Intervention Type BEHAVIORAL

Placebo (sham) for insomnia

CPAP+CBT

CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

Treatment for sleep apnea

CBT

Intervention Type BEHAVIORAL

Treatment for insomnia

Interventions

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CPAP

Treatment for sleep apnea

Intervention Type DEVICE

CBT

Treatment for insomnia

Intervention Type BEHAVIORAL

sham CPAP

Placebo for sleep apnea

Intervention Type DEVICE

CC

Placebo (sham) for insomnia

Intervention Type BEHAVIORAL

Other Intervention Names

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Continuous positive airway pressure therapy Cognitive-Behavioral Therapy for Insomnia Sham (placebo) continuous positive airway pressure Contact control

Eligibility Criteria

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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 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Pennsylvania Health System

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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R34HL109462

Identifier Type: NIH

Identifier Source: secondary_id

View Link

814153

Identifier Type: -

Identifier Source: org_study_id

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