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Can personalized music ease dementia care battles? a trial tests a Drug-Free approach

NCT ID NCT07730957

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Behavior Burnout, Professional cognitive disorder Cognitive Dysfunction dementia occupation-related stress disorder Psychomotor Agitation

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.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • La Meulière de la Marne

    NOT_YET_RECRUITING

    La Ferté-sous-Jouarre, 77260, France

  • Les Jardins d'Henriville

    RECRUITING

    Amiens, 80000, France

  • Les Jardins de Leysotte

    NOT_YET_RECRUITING

    Villenave-d'Ornon, 33140, France

  • Parc de Diane

    RECRUITING

    Nantes, 44200, France

  • Résidence La Chézalière

    RECRUITING

    Nantes, 44100, France

  • Résidence Les Nymphéas

    RECRUITING

    Pacé, 35740, France

  • Résidence Verte Prairie

    NOT_YET_RECRUITING

    Salon-de-Provence, 13300, France

  • Villa Amélie

    NOT_YET_RECRUITING

    Saint-Rogatien, 17220, France

  • Villa Bourgailh

    RECRUITING

    Pessac, 33600, France

  • Villa Tohannic

    NOT_YET_RECRUITING

    Vannes, 56000, France

  • Villa d'Épidaure Garches

    RECRUITING

    Garches, 92380, France

  • Villa d'Épidaure La Celle St Cloud

    NOT_YET_RECRUITING

    La Celle-Saint-Cloud, 78170, France

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