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

Not Applicable

Completed

• Conditions: Sleep Apnea; Insomnia
• Interventions: Behavioral: Sleep hygiene advice; Behavioral: Self-help book for insomnia

• Registration Number: NCT02279056
• Lead Sponsor: University of Bergen

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.

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-10-28
• Study First Posted: 2014-10-30
• Status Verified: 2017-10
• Primary Completion: 2017-10-20
• Study Completion: 2017-10-20
• Last Update Submitted: 2017-10-26
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 181

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep hygiene advice	Sleep hygiene advice	A sheet of paper with sleep hygiene advice.
Self-help book	Self-help book for insomnia	A self-help book for insomnia (written in Norwegian). Earlier proven to be effective among insomnia patients (without OSA co-morbidity).

Primary Outcome Measures

Name	Time	Method
Insomnia severity	3 months	Self-reported using a validated insomnia scale

Secondary Outcome Measures

Name	Time	Method
CPAP compliance	3 months	Using objective data from CPAP device
Sleep apnea severity	3 months	Using objective apnea-hypopnea index from CPAP device
Insomnia prevalence	3 months	Self-reported using a validated insomnia scale

Trial Locations

Locations (1)

University of Bergen; 🇳🇴 Bergen, Hordaland, Norway