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

Sleep Disturbance Clinical Trial

Official title:

The Effect of Listening to Music on Sleep Disturbances in Patients With Acquired Brain Injuries

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620069
• Other study ID #: 2
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 15, 2019

Study information

• Verified date: November 2022
• Source: Vejlefjord Rehabilitation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Brain Injuries
• Dyssomnias
• Parasomnias
• Sleep Disturbance
• Wounds and Injuries

Intervention

Other:
• Music listening
Participants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period.

Locations

Country	Name	City	State
Denmark	Vejlefjord Rehabilitation	Stouby

Sponsors (3)

Lead Sponsor	Collaborator
Vejlefjord Rehabilitation	Aalborg University, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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