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

NCT ID: NCT02279056

Last Updated: 2017-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

181 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-10-20

Brief Summary

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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

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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.

Conditions

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Sleep Apnea Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Self-help book

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

Group Type EXPERIMENTAL

Self-help book for insomnia

Intervention Type BEHAVIORAL

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

A sheet of paper with sleep hygiene advice.

Group Type PLACEBO_COMPARATOR

Sleep hygiene advice

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Bjorn Bjorvatn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bjørn Bjorvatn, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

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University of Bergen

Bergen, Hordaland, Norway

Site Status

Countries

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Norway

Other Identifiers

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02279056

Identifier Type: -

Identifier Source: org_study_id