Music Listening and Sleep in Rehabilitation of People With Acquired Brain Injury

Not Applicable

Completed

• Conditions: Brain Injuries; Sleep Disturbance
• Interventions: Other: Music listening

• Registration Number: NCT05620069
• Lead Sponsor: Vejlefjord Rehabilitation

Brief Summary

An Injury to the brain may lead to sleep-wake disturbances which may negatively influence functional recovery, quality of life and general rehabilitation.

The purpose of this study is to investigate the effect of music listening on sleep disturbances after acquired brain injury (ABI).

During a 2 week intervention period patients with ABI will listen to music for appr. 30 minutes before going to sleep. Records of their sleep quality are compared to records of sleep quality from 2 weeks without music intervention.

H1 Hypothesis: Music listening (ML) improves sleep quality after ABI in patients.

H0 Hypothesis: Music listening (ML) has no effect on sleep quality after ABI in patients.

Detailed Description

Participants are recruited from Vejlefjord Rehabilitation - a neurorehabilitation center in Denmark.

Patients who meet the inclusion criteria are enrolled in the study after informed consent. Participants are randomly allocated to two conditions (ML+Treatment as usual (TAU) or TAU only in a crossover design. Randomization is done by sealed envelope, and after two weeks of either ML+TAU or TAU the participants switch condition.

Participants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period. Participants will rate sleep quality and liking of the intervention.

Information about injury, demographic and socioeconomic status are derived from patient journals.

Study Timeline

• Study First Submitted: 2019-01-31
• Study Start: 2019-02-01
• Primary Completion: 2019-07-15
• Study Completion: 2019-07-15
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-10
• Last Update Submitted: 2022-11-10
• Study First Posted: 2022-11-17
• Last Update Posted: 2022-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• in-patients with ABI being treated at Vejlefjord Rehabilitation during the entire project period
• age > 18 years
• sleep-wake disturbances corresponding a score of 5 or more on Pittsburgh Sleep Quality Index (PSQI).
• Mentally and physically capable of administering music equipment, actigraph and self-report questionnaires.

Exclusion Criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Music listening at bed time	Music listening	-

Primary Outcome Measures

Name	Time	Method
Sleep quality	Change from baseline to after the 14-days intervention period	Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.
Objective sleep quality	Change from baseline to after the 14-days intervention period	Measured with wrist-worn actigraphy registrering body movements from which you can derive the sleep-wake pattern.

Trial Locations

Locations (1)

Vejlefjord Rehabilitation; 🇩🇰 Stouby, Denmark