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

N/ACompletedNCT05620069

Vejlefjord Rehabilitation5 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Injuries

Interventions

Music listeningOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Vejlefjord Rehabilitation

Stouby, Denmark

Outcomes

Primary Outcomes

Sleep quality

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

Objective sleep quality

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

Data from ClinicalTrials.gov

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