Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT05620069
Status:
COMPLETED
Last Update Posted:
2022-11-17
First Post:
2019-01-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Music Listening and Sleep in Rehabilitation of People With Acquired Brain Injury
Sponsor:
Vejlefjord Rehabilitation
Organization:
Study Overview
Official Title:
The Effect of Listening to Music on Sleep Disturbances in Patients With Acquired Brain Injuries
Status:
COMPLETED
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: