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

NCT ID: NCT05620069

Last Updated: 2022-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-07-15

Brief Summary

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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

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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.

Conditions

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Brain Injuries Sleep Disturbance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Music listening at bed time

Group Type EXPERIMENTAL

Music listening

Intervention Type OTHER

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

Treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role collaborator

Vejlefjord Rehabilitation

OTHER

Sponsor Role lead

Responsible Party

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Mette Underbjerg

Head of Research and Development

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mette Underbjerg, PhD

Role: PRINCIPAL_INVESTIGATOR

Vejlefjord Rehabilitation

Locations

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Vejlefjord Rehabilitation

Stouby, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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2

Identifier Type: -

Identifier Source: org_study_id

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