NCT05069285

Brief Summary

The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
172

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

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

First Submitted

Initial submission to the registry

September 23, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 10, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2024

Completed
Last Updated

June 10, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

September 23, 2021

Last Update Submit

June 7, 2024

Conditions

Hypnotic; Sleep Disorder

Outcome Measures

Primary Outcomes (3)

  • Use of hypnotics assessed as days per week

    Self-reported sleep medication use (days of use per week,0-7)

    3-6 months

  • Insomnia severity assessed with Insomnia Severity Index

    Self-reported sleep problems on the validated Insomnia Severity Index (0-28), with higher scores indicating worse sleep

    3-6 months

  • Insomnia severity assessed with Bergen Insomnia Scale

    Self-reported sleep problems on the validated Bergen Insomnia Scale (0-42), with higher scores indicating worse sleep

    3-6 months

Study Arms (2)

Self-help book

EXPERIMENTAL

A self-help book for insomnia (written in Norwegian)

Other: self-help book

Sleep hygiene advice

ACTIVE COMPARATOR

A sheet of paper with standard sleep hygiene advice

Other: sleep hygiene advice

Interventions

self-help bookOTHER

information and advice given in the self-help book

Self-help book
sleep hygiene adviceOTHER

information and advice given on the sheet of paper with sleep hygiene

Sleep hygiene advice

Eligibility Criteria

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

You may qualify if:

  • \- Use of sleep medications on prescription or OTC during the last 6 months

You may not qualify if:

  • \- Below 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Vestland, 5019, Norway

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Bjørn Bjorvatn, MD PhD

    University of Bergen

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 6, 2021

Study Start

May 10, 2023

Primary Completion

May 10, 2024

Study Completion

May 10, 2024

Last Updated

June 10, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)