Randomized Controlled Trial of a Self-help Book for Insom... | NCT02279056

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

NCT02279056

Sponsor

University of Bergen

Status

Completed

Last Update Posted

Oct 27, 2017Actual

Enrollment

181Actual

Phase

Not Applicable

Conditions

Sleep Apnea
Insomnia

Interventions

Self-help book for insomnia
Sleep hygiene advice

Countries

Norway

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2014

Primary Completion Date

Oct 20, 2017Actual

Completion Date

Oct 20, 2017Actual

First Submitted Date

Oct 23, 2014

First Submission Date that Met QC Criteria

Oct 28, 2014

First Posted Date

Oct 30, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 26, 2017

Last Update Posted Date

Oct 27, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

181Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.	Self-help book

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Insomnia severity	Self-reported using a validated insomnia scale	3 months

Secondary Outcomes

Measure	Description	Time Frame
CPAP compliance	Using objective data from CPAP device	3 months
Sleep apnea severity	Using objective apnea-hypopnea index from CPAP device

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bjørn Bjorvatn, MD PhD	University of Bergen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Bergen		Bergen	Hordaland	5018	Norway

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes
D007319	Sleep Initiation and Maintenance Disorders

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided