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Completed

NCT Number: NCT02279056

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

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.

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Key information

Conditions

Sleep Apnea Apnea Dyssomnias Insomnia Mental Disorders Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Hordaland, 5018, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self-help book for insomnia

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

Behavioral

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

Primary outcomes

  1. Insomnia severity

    Time frame: 3 months

    Self-reported using a validated insomnia scale

Secondary outcomes

  1. CPAP compliance

    Time frame: 3 months

    Using objective data from CPAP device

  2. Sleep apnea severity

    Time frame: 3 months

    Using objective apnea-hypopnea index from CPAP device

  3. Insomnia prevalence

    Time frame: 3 months

    Self-reported using a validated insomnia scale

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Registry information

Official study title

A Randomized Controlled Trial (RCT) of a Self-help Book for Insomnia in Patients With Co-morbid Obstructive Sleep Apnea (OSA) and Insomnia

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2014
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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