NCT02279056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
181

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

October 23, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 30, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

3.1 years

First QC Date

October 23, 2014

Last Update Submit

October 26, 2017

Conditions

Sleep ApneaInsomnia

Outcome Measures

Primary Outcomes (1)

  • Insomnia severity

    Self-reported using a validated insomnia scale

    3 months

Secondary Outcomes (3)

  • CPAP compliance

    3 months

  • Sleep apnea severity

    3 months

  • Insomnia prevalence

    3 months

Study Arms (2)

Self-help book

EXPERIMENTAL

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

Sleep hygiene advice

PLACEBO COMPARATOR

A sheet of paper with sleep hygiene advice.

Behavioral: Sleep hygiene advice

Interventions

Self-help book for insomniaBEHAVIORAL

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

Self-help book
Sleep hygiene adviceBEHAVIORAL

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with OSA and scheduled for CPAP treatment.
  • Having co-morbid insomnia.

You may not qualify if:

  • Less than 18 years of age
  • Not fluent in Norwegian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Hordaland, 5018, Norway

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Bjørn Bjorvatn, MD PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 23, 2014

First Posted

October 30, 2014

Study Start

October 1, 2014

Primary Completion

October 20, 2017

Study Completion

October 20, 2017

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

NO(1)