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Completed

NCT Number: NCT05620069

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

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.

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Parasomnias Sleep Disturbance Sleep Wake Disorders Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vejlefjord Rehabilitation

Stouby, 7140, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Music listening

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.

Primary outcomes

  1. Sleep quality

    Time frame: 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.

  2. Objective sleep quality

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Vejlefjord Rehabilitation

Other

Collaborators

  • Aalborg University
  • University of Aarhus

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 17, 2022
Registry last updated
Nov 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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