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

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ClinicalTrials.gov Identifier: NCT02279056
Recruitment Status : Completed
First Posted : October 30, 2014
Last Update Posted : October 27, 2017
Sponsor:
Information provided by (Responsible Party):
Bjorn Bjorvatn, University of Bergen

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Insomnia Behavioral: Self-help book for insomnia Behavioral: Sleep hygiene advice Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 181 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : October 2014
Actual Primary Completion Date : October 20, 2017
Actual Study Completion Date : October 20, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Self-help book
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
RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.

Placebo Comparator: Sleep hygiene advice
A sheet of paper with sleep hygiene advice.
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.




Primary Outcome Measures :
  1. Insomnia severity [ Time Frame: 3 months ]
    Self-reported using a validated insomnia scale


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279056


Locations
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Norway
University of Bergen
Bergen, Hordaland, Norway, 5018
Sponsors and Collaborators
University of Bergen
Investigators
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Principal Investigator: Bjørn Bjorvatn, MD PhD University of Bergen

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Responsible Party: Bjorn Bjorvatn, Professor, University of Bergen
ClinicalTrials.gov Identifier: NCT02279056    
Other Study ID Numbers: 02279056
First Posted: October 30, 2014    Key Record Dates
Last Update Posted: October 27, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Initiation and Maintenance Disorders
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders