Music Listening and Sleep in Rehabilitation of People Wit... | NCT05620069

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

NCT05620069

Sponsor

Vejlefjord Rehabilitation

Status

Completed

Last Update Posted

Nov 17, 2022Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Brain Injuries
Sleep Disturbance

Interventions

Music listening

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Jul 15, 2019Actual

Completion Date

Jul 15, 2019Actual

First Submitted Date

Jan 31, 2019

First Submission Date that Met QC Criteria

Nov 10, 2022

First Posted Date

Nov 17, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 10, 2022

Last Update Posted Date

Nov 17, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mette Underbjerg, Head of Research and Development, Vejlefjord RehabilitationPrincipal Investigator

Lead Sponsor

Vejlefjord RehabilitationOTHER

Collaborators

Name	Class
University of Aarhus	OTHER
Aalborg University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Music listening at bed time	Experimental		Other: Music listening
Treatment as usual	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mette Underbjerg, PhD	Vejlefjord Rehabilitation	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Vejlefjord Rehabilitation		Stouby		7140	Denmark

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001930	Brain Injuries
D020447	Parasomnias

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D006259	Craniocerebral Trauma

Browse Leaves

Not provided

Browse Branches

Not provided