NCT07730957 · RECRUITING
Protocolized Receptive Music Intervention to Reduce Care Refusal in Nursing Home Residents With Major Neurocognitive Disorders
This trial tests whether playing structured, personalized music during daily bathing and hygiene care can reduce the agitation and refusal behaviors common in nursing home residents with dementia. It compares music played only during care versus music played before and during care versus standard practice. This is a Phase NA randomized study — it is evaluating a non-drug approach in a real-world care setting, not testing a new medication.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-07-28