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Clinical Trials/NCT02279056
NCT02279056
Completed
Not Applicable

A Randomized Controlled Trial (RCT) of a Self-help Book for Insomnia in Patients With Co-morbid Obstructive Sleep Apnea (OSA) and Insomnia

University of Bergen1 site in 1 country181 target enrollmentOctober 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Apnea
Sponsor
University of Bergen
Enrollment
181
Locations
1
Primary Endpoint
Insomnia severity
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 20, 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bjorn Bjorvatn

Professor

University of Bergen

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

Outcomes

Primary Outcomes

Insomnia severity

Time Frame: 3 months

Self-reported using a validated insomnia scale

Secondary Outcomes

  • CPAP compliance(3 months)
  • Sleep apnea severity(3 months)
  • Insomnia prevalence(3 months)

Study Sites (1)

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