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NCT02279056 Clinical Trial

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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02279056
Other study ID # 02279056
Secondary ID
Status Completed
Phase N/A
First received October 23, 2014
Last updated October 26, 2017
Start date October 2014
Est. completion date October 20, 2017

Study information
Verified date October 2017
Source University of Bergen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 181
Est. completion date October 20, 2017
Est. primary completion date October 20, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Self-help book for insomnia
RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.
• Sleep hygiene advice
RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.

Locations
Country Name City State
Norway University of Bergen Bergen Hordaland

Sponsors (1)
Lead Sponsor Collaborator
University of Bergen

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Insomnia severity Self-reported using a validated insomnia scale 3 months
Secondary CPAP compliance Using objective data from CPAP device 3 months
Secondary Sleep apnea severity Using objective apnea-hypopnea index from CPAP device 3 months
Secondary Insomnia prevalence Self-reported using a validated insomnia scale 3 months
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