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

University of Bergen

Status: Completed

Conditions: Insomnia; Sleep Apnea

Treatments: Behavioral: Self-help book for insomnia; Behavioral: Sleep hygiene advice

Study type: Interventional

Funder types: Other

Identifiers

NCT02279056

02279056

Details and patient eligibility

About

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.

Full 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.

Enrollment: 181 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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181 participants in 2 patient groups, including a placebo group

Self-help book

Experimental group

Description:

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

Treatment:

Behavioral: Self-help book for insomnia

Sleep hygiene advice

Placebo Comparator group

Description:

A sheet of paper with sleep hygiene advice.

Treatment:

Behavioral: Sleep hygiene advice