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

Study 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.

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

Conditions
-----------------
Sleep Apnea, Insomnia

Intervention / Treatment
-----------------
* Behavioral: Self-help book for insomnia
* Behavioral: Sleep hygiene advice


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self-help book<br>A self-help book for insomnia (written in Norwegian). Earlier proven to be effective among insomnia patients (without OSA co-morbidity). | Behavioral: Self-help book for insomnia<br>* RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.<br>|
| Placebo Comparator: Sleep hygiene advice<br>A sheet of paper with sleep hygiene advice. | Behavioral: Sleep hygiene advice<br>* RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia severity | Self-reported using a validated insomnia scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAP compliance | Using objective data from CPAP device | 3 months | 
| Sleep apnea severity | Using objective apnea-hypopnea index from CPAP device | 3 months | 
| Insomnia prevalence | Self-reported using a validated insomnia scale | 3 months |