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Randomized Controlled Trial of a Self-help Book for Insomnia in Patients With Co-morbid OSA and Insomnia

Primary Purpose

Sleep Apnea, Insomnia

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Self-help book for insomnia
Sleep hygiene advice
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea

Eligibility Criteria

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

Inclusion Criteria:

  • Patients diagnosed with OSA and scheduled for CPAP treatment.
  • Having co-morbid insomnia.

Exclusion Criteria:

  • Less than 18 years of age
  • Not fluent in Norwegian

Sites / Locations

  • University of Bergen

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Self-help book

Sleep hygiene advice

Arm Description

A self-help book for insomnia (written in Norwegian). Earlier proven to be effective among insomnia patients (without OSA co-morbidity).

A sheet of paper with sleep hygiene advice.

Outcomes

Primary Outcome Measures

Insomnia severity
Self-reported using a validated insomnia scale

Secondary Outcome Measures

CPAP compliance
Using objective data from CPAP device
Sleep apnea severity
Using objective apnea-hypopnea index from CPAP device
Insomnia prevalence
Self-reported using a validated insomnia scale

Full Information

First Posted
October 23, 2014
Last Updated
October 26, 2017
Sponsor
University of Bergen
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1. Study Identification

Unique Protocol Identification Number
NCT02279056
Brief Title
Randomized Controlled Trial of a Self-help Book for Insomnia in Patients With Co-morbid OSA and Insomnia
Official Title
A Randomized Controlled Trial (RCT) of a Self-help Book for Insomnia in Patients With Co-morbid Obstructive Sleep Apnea (OSA) and Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
October 20, 2017 (Actual)
Study Completion Date
October 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Obstructive sleep apnea (OSA) is a common sleep disorder treated with continuous positive airway pressure (CPAP). Some OSA patients also suffer from co-morbid insomnia. CPAP treatment may be complicated in patients with co-morbid insomnia. This project evaluates the effects of a self-help book for insomnia in patients being treated with CPAP for OSA.
Detailed Description
This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia in patients with obstructive sleep apnea (OSA) and co-morbid insomnia. 180 patients are randomized to either receive the self-help book (90 patients) or sleep hygiene advice (90 patients). Patients fill out questionnaires about sleep and health both at baseline and after three months. Furthermore, CPAP compliance and OSA severity will be evaluated after three months of CPAP use. The aim is to evaluate whether the self-help book will improve sleep parameters and CPAP compliance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
181 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self-help book
Arm Type
Experimental
Arm Description
A self-help book for insomnia (written in Norwegian). Earlier proven to be effective among insomnia patients (without OSA co-morbidity).
Arm Title
Sleep hygiene advice
Arm Type
Placebo Comparator
Arm Description
A sheet of paper with sleep hygiene advice.
Intervention Type
Behavioral
Intervention Name(s)
Self-help book for insomnia
Intervention Description
RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.
Intervention Type
Behavioral
Intervention Name(s)
Sleep hygiene advice
Intervention Description
RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.
Primary Outcome Measure Information:
Title
Insomnia severity
Description
Self-reported using a validated insomnia scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
CPAP compliance
Description
Using objective data from CPAP device
Time Frame
3 months
Title
Sleep apnea severity
Description
Using objective apnea-hypopnea index from CPAP device
Time Frame
3 months
Title
Insomnia prevalence
Description
Self-reported using a validated insomnia scale
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients diagnosed with OSA and scheduled for CPAP treatment. Having co-morbid insomnia. Exclusion Criteria: Less than 18 years of age Not fluent in Norwegian
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Bjorvatn, MD PhD
Organizational Affiliation
University of Bergen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Bergen
City
Bergen
State/Province
Hordaland
ZIP/Postal Code
5018
Country
Norway

12. IPD Sharing Statement

Learn more about this trial

Randomized Controlled Trial of a Self-help Book for Insomnia in Patients With Co-morbid OSA and Insomnia

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