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

NCT05620069 | Completed

• 1 other identifier: 2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Injuries; Sleep Disturbance

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (2)

Music listening at bed time

EXPERIMENTAL

Other: Music listening

Treatment as usual

NO INTERVENTION

Interventions

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.

Music listening at bed time

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Vejlefjord Rehabilitation: lead
• University of Aarhus: collaborator
• Aalborg University: collaborator

Study Sites (1)

Vejlefjord Rehabilitation

Stouby, 7140, Denmark

Location

MeSH Terms

Conditions

Brain Injuries; Parasomnias

Condition Hierarchy (Ancestors)

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

Study Officials

• Mette Underbjerg, PhD

  Vejlefjord Rehabilitation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research and Development

Study Record Dates

• First Submitted: January 31, 2019
• First Posted: November 17, 2022
• Study Start: February 1, 2019
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)