Brain InjuriesNCT05620069
Music Listening and Sleep in Rehabilitation of People With Acquired Brain Injury
A study testing Music listening in people with Brain Injuries and Sleep Disturbance, run by Vejlefjord Rehabilitation at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Sleep Disturbance
- What is being tested?
- Music listening
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2019to 15 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Listening to Music on Sleep Disturbances in Patients With Acquired Brain Injuries
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.
Read the 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.
- Conditions
- Brain Injuries, Sleep Disturbance
- Being tested
- Music listening
- Keywords
- Brain injury, Acquired brain injury, Sleep disturbance, Music, Music therapy
- Medical subject headings
- Brain Injuries, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Music listening at bed time | Experimental | Not described Receives: Other: Music listening |
| Treatment as usual | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
Measured with the Pittsburgh Sleep Quality Index, range 0-21 with higher scores indicating more sleep problems.
Measured: 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.
Measured: Change from baseline to after the 14-days intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Feb 2019
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejlefjord Rehabilitation
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aalborg University
- Responsible party
- Principal investigator, Mette Underbjerg, Vejlefjord Rehabilitation
- Investigators
- Mette Underbjerg, PhD, Principal investigator, Vejlefjord Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620069
- Sponsor's protocol ID
- 2
- Status last verified
- Nov 2022
- First submitted
- 31 Jan 2019
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Listening to Music on Sleep Disturbances in Patients With Acquired Brain Injuries
- ClinicalTrials.gov ID
- NCT05620069
- Acronym / sponsor ID
- 2
- Conditions
- Brain Injuries, Sleep Disturbance
- Keywords
- Brain injury, Acquired brain injury, Sleep disturbance, Music, Music therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vejlefjord RehabilitationUniversity, hospital or other
- Collaborators
- University of Aarhus, Aalborg University
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music listening at bed time | Experimental | Other: Music listening |
| Treatment as usual | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music listeningParticipants are asked to select one of four music playlists and listen to it for appr. 30 minutes at bedtime during the intervention period. | Other | Music listening at bed time |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mette Underbjerg, PhD principal investigator
Vejlefjord Rehabilitation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music listening in people with Brain Injuries and Sleep Disturbance, run by Vejlefjord Rehabilitation at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: Change from baseline to after the 14-days intervention period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.