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Understanding the Sleep Apnea/Insomnia Interaction

Primary Purpose

Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CPAP
CBT
sham CPAP
CC
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea Syndromes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania Health System

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Sham Comparator

Active Comparator

Arm Label

CPAP+CC

sham CPAP+CC

CPAP+CBT

Arm Description

Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia)

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

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

Outcomes

Primary Outcome Measures

Insomnia Severity Index Score
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.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2013
Last Updated
July 27, 2020
Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01824472
Brief Title
Understanding the Sleep Apnea/Insomnia Interaction
Official Title
Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
March 2013 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CPAP+CC
Arm Type
Active Comparator
Arm Description
Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia)
Arm Title
sham CPAP+CC
Arm Type
Sham Comparator
Arm Description
sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia)
Arm Title
CPAP+CBT
Arm Type
Active Comparator
Arm Description
CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia
Intervention Type
Device
Intervention Name(s)
CPAP
Other Intervention Name(s)
Continuous positive airway pressure therapy
Intervention Description
Treatment for sleep apnea
Intervention Type
Behavioral
Intervention Name(s)
CBT
Other Intervention Name(s)
Cognitive-Behavioral Therapy for Insomnia
Intervention Description
Treatment for insomnia
Intervention Type
Device
Intervention Name(s)
sham CPAP
Other Intervention Name(s)
Sham (placebo) continuous positive airway pressure
Intervention Description
Placebo for sleep apnea
Intervention Type
Behavioral
Intervention Name(s)
CC
Other Intervention Name(s)
Contact control
Intervention Description
Placebo (sham) for insomnia
Primary Outcome Measure Information:
Title
Insomnia Severity Index Score
Description
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.
Time Frame
Between Baseline and Day 42.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sleep Apnea Insomnia Age >18 Exclusion Criteria: Sedative/psychoactive drug use recently Other clinically significant sleep disorders Previous treatment for obstructive sleep apnea (OSA) Requires oxygen or bilevel PAP therapy Clinically unstable medical condition Recent shift work Significant alcohol use Other clinically significant causes of insomnia Illicit drug use Prescription stimulants Safety restrictions Unable to treat sleep apnea with positive airway pressure therapy Communication barriers Cognitive impairment
Facility Information:
Facility Name
University of Pennsylvania Health System
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Understanding the Sleep Apnea/Insomnia Interaction

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