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

Primary Purpose

Brain Injuries, Sleep Disturbance

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Music listening

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Brain injury, Acquired brain injury, Sleep disturbance, Music, Music therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: -

Sites / Locations

Vejlefjord Rehabilitation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Music listening at bed time

Treatment as usual

Arm Description

Outcomes

Primary Outcome Measures

Sleep quality

Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.

Objective sleep quality

Measured with wrist-worn actigraphy registrering body movements from which you can derive the sleep-wake pattern.

Secondary Outcome Measures

Full Information

NCT ID

NCT05620069

First Posted

January 31, 2019

Last Updated

November 10, 2022

Sponsor

Vejlefjord Rehabilitation

Collaborators

University of Aarhus, Aalborg University

1. Study Identification

Unique Protocol Identification Number

NCT05620069

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Completed

Study Start Date

February 1, 2019 (Actual)

Primary Completion Date

July 15, 2019 (Actual)

Study Completion Date

July 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vejlefjord Rehabilitation

Collaborators

University of Aarhus, Aalborg University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Brain Injuries, Sleep Disturbance

Keywords

Brain injury, Acquired brain injury, Sleep disturbance, Music, Music therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Music listening at bed time

Arm Type

Experimental

Arm Title

Treatment as usual

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Music listening

Intervention Description

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

Primary Outcome Measure Information:

Title

Sleep quality

Description

Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.

Time Frame

Change from baseline to after the 14-days intervention period

Title

Objective sleep quality

Description

Measured with wrist-worn actigraphy registrering body movements from which you can derive the sleep-wake pattern.

Time Frame

Change from baseline to after the 14-days intervention period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mette Underbjerg, PhD

Organizational Affiliation

Vejlefjord Rehabilitation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vejlefjord Rehabilitation

City

Stouby

ZIP/Postal Code

7140

Country

Denmark

12. IPD Sharing Statement

Plan to Share IPD

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

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