DementiaNCT03445299
Music for Dementia-related Sleep Problems
A study testing Music in people with Dementia and Insomnia, run by University of Aarhus at 1 site in Denmark.
Trial summary
The study aims to evaluate the effect of listening to music at bedtime on sleep in elderly persons with dementia and sleep problems. Read more about this study
- Who is it for?
- Ages 60 years and older
- What is being tested?
- Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Feb 2018to 1 Dec 2018
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dementia
- Sleep problems
Who cannot join
- Use of hypnotic medications
- Substance abuse
- Severe hearing deficits
- Not out of bed during daytime
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dementia and Sleep
The study aims to evaluate the effect of listening to music at bedtime on sleep in elderly persons with dementia and sleep problems.
Read the detailed description
The study is a clinical trial to assess the effect of music listening as intervention for improving sleep in elderly persons with dementia and sleep problems. We use a within-subject design to evaluate the effect of the music intervention. Participants are persons above the age of 60 diagnosed with dementia and suffering from sleep problems. We will examine the effect of the intervention on sleep, mood and cognition.
- Being tested
- Music
- Medical subject headings
- Dementia, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
Listening to music for 30 minutes at bedtime
| Study group | Role | What they receive |
|---|---|---|
| Music | Experimental | Daily music listening for 30 minutes at bedtime Receives: Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep
Change in sleep pattern measured objectively with wrist actigraphy
Measured: 14 days baseline and 14 days intervention
Secondary outcomes (4)
Sleep quality
Change in sleep quality reported by primary caregiver (5 point Likert scale: 0=no change - 4=extreme change)
Measured: After 14 days intervention period
Depression
Change in depressive symptoms as measured by the Geriatric Depression Scale (GDS). Scoring range 0-15. 0-4=no depression, 5-7=potential depression, >8=probable depression.
Measured: Measured at baseline and after 14 days intervention period
Cognition
Change in cognitive functioning as measured by the Mini-Mental-State Examination (MMSE)
Measured: Measured at baseline and after 14 days intervention period
Mood
Change in mood as reported by primary caregiver (5 point Likert scale: 0= no change - 4=extreme change)
Measured: After 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 posted26 Feb 2018
- Study start26 Feb 2018
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Within-subject design
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark
- Responsible party
- Sponsor
- Investigators
- Jan Larsen, Study chair, Technical University of Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03445299
- Sponsor's protocol ID
- D&S2017
- Status last verified
- Jan 2019
- First submitted
- 21 Dec 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia and Sleep
- ClinicalTrials.gov ID
- NCT03445299
- Acronym / sponsor ID
- D&S2017
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Technical University of Denmark
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 26 Feb 2018 (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.
The study aims to evaluate the effect of listening to music at bedtime on sleep in elderly persons with dementia and sleep problems.
Detailed description
The study is a clinical trial to assess the effect of music listening as intervention for improving sleep in elderly persons with dementia and sleep problems. We use a within-subject design to evaluate the effect of the music intervention. Participants are persons above the age of 60 diagnosed with dementia and suffering from sleep problems. We will examine the effect of the intervention on sleep, mood and cognition.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within-subject design
| Arm | Type | Receives |
|---|---|---|
| Music | Experimental | Behavioral: MusicDaily music listening for 30 minutes at bedtime |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Dementia
- Sleep problems
Key exclusion criteria (4 listed)
- Use of hypnotic medications
- Substance abuse
- Severe hearing deficits
- Not out of bed during daytime
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 |
|---|---|---|
| MusicListening to music for 30 minutes at bedtime | Behavioural | Music |
Primary outcome
Sleep
Time frame: 14 days baseline and 14 days intervention
Change in sleep pattern measured objectively with wrist actigraphy
4 secondary outcomes
Sleep quality
Time frame: After 14 days intervention period
Depression
Time frame: Measured at baseline and after 14 days intervention period
Cognition
Time frame: Measured at baseline and after 14 days intervention period
Mood
Time frame: After 14 days intervention period
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 25 Jan 2019.
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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.
Jan Larsen study chair
Technical University of Denmark
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 in people with Dementia and Insomnia, run by University of Aarhus 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 2 inclusion and 4 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 25 Jan 2019. 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 (time frame: 14 days baseline and 14 days intervention). 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 25 Jan 2019.