Can personalized music ease dementia care battles? a trial tests a Drug-Free approach
NCT ID NCT07730957
First seen Jul 28, 2026 · Last updated Jul 29, 2026 · Updated 1 time
Summary
This randomized trial tests whether a structured, personalized music program (MUSIC CARE©) can reduce care refusal during daily hygiene care in nursing home residents with dementia. Care refusal—resisting bathing, dressing, or medication—is common and stressful for both residents and staff. The study compares two music protocols (20 minutes during care vs. 20 minutes before plus 20 minutes during care) against usual practice, measuring care acceptance, behavioral symptoms, medication use, and caregiver burnout over four weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a personalized digital receptive music therapy device (MUSIC CARE©) delivering algorithmically composed instrumental music sequences
- What this could lead to
- If effective, this could offer a drug-free way to reduce distress and care refusal in people with dementia, potentially improving quality of life for residents and reducing burnout for caregivers.
- What could go wrong
- This is a small, early-stage trial with 60 participants, so results may not apply broadly. Music may not work for everyone, and some residents could become more agitated.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
RESIDENT ELIGIBILITY Inclusion Criteria: * Living in a LNA Santé EHPAD (nursing home) as a permanent resident for at least 3 months * Diagnosed Alzheimer's disease or a related disorder, or confirmed cognitive decline shown by a Mini-Mental State Examination (MMSE - a short memory and thinking test) score of 24 or less within the past 12 months (including cases where the MMSE cannot be administered due to severe cognitive impairment) * Showing care refusal behavior, defined as an Agitation/Aggression item score on the NPI-ES scale (frequency × severity) greater than or equal to 4 at the time of inclusion * Resident and/or their legal representative or trusted person has given written consent to participate * Affiliated to a French social security scheme Exclusion Criteria: * Uncompensated hearing loss with sensory isolation (unable to benefit from music therapy) * Documented end-of-life status in the medical record CAREGIVER ELIGIBILITY Inclusion Criteria (Caregivers): * Adult (18 years of age or older) * Working in the care unit of an enrolled resident and performing hygiene/nursing care (bathing) * Able to read and write French * Affiliated to a French social security scheme * Has given written consent to participate Exclusion Criteria (Caregivers): * Employment contract shorter than the resident's 3-month study follow-up period (i.e., unable to complete all 3 caregiver assessments) * Unable to provide informed consent to participate * Under legal protection as defined by Article 1121-8 of the French Public Health Code (under legal guardianship or deprived of liberty) * Not affiliated to a French social security scheme
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
12 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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La Meulière de la Marne
NOT_YET_RECRUITINGLa Ferté-sous-Jouarre, 77260, France
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Les Jardins d'Henriville
RECRUITINGAmiens, 80000, France
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Les Jardins de Leysotte
NOT_YET_RECRUITINGVillenave-d'Ornon, 33140, France
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Parc de Diane
RECRUITINGNantes, 44200, France
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Résidence La Chézalière
RECRUITINGNantes, 44100, France
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Résidence Les Nymphéas
RECRUITINGPacé, 35740, France
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Résidence Verte Prairie
NOT_YET_RECRUITINGSalon-de-Provence, 13300, France
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Villa Amélie
NOT_YET_RECRUITINGSaint-Rogatien, 17220, France
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Villa Bourgailh
RECRUITINGPessac, 33600, France
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Villa Tohannic
NOT_YET_RECRUITINGVannes, 56000, France
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Villa d'Épidaure Garches
RECRUITINGGarches, 92380, France
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Villa d'Épidaure La Celle St Cloud
NOT_YET_RECRUITINGLa Celle-Saint-Cloud, 78170, France
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