Not Yet RecruitingNot Applicable

Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)

France48 participantsStarted 2026-06

Plain-language summary

This is a prospective, multicenter study designed to evaluate the benefits of an evening music-based intervention on sundowning syndrome in patients with Alzheimer's disease or related disorders in a Protect lLife Unit setting.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Signature of consent by the patient's legal guardian obtained after providing information * Patients aged 60 and over who meet the diagnostic criteria for Alzheimer's disease and related disorders, including mainly: Lewy body disease, frontotemporal lobar degeneration, progressive supranuclear palsy, corticobasal degeneration, vascular encephalopathy, alcoholic dementia, primary progressive aphasia syndrome, posterior cortical atrophy syndrome (France Alzheimer, 2024). * Patient living in a secure care unit * If taking psychotropic drugs, they must have been stable for 3 months * If taking level 2 or 3 painkillers, they must have been stable for 1 month Exclusion Criteria: * Refusal to participate * Participation in a study on a drug/medical device/treatment technique that may affect sleep or behavior. * Highly sedated patients, * Patients with acute medical instability, * Patients with productive delusions, * Patients who have been in the unit for less than 1 month

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Music

Timeframe: Baseline (Days 1-10); TEST intervention (Days 11-20); post-intervention follow-up (Days 21-40); CONTROL intervention (Days 41-50); post-control follow-up (Days 51-60). Outcomes assessed throughout all study periods.

Trial details

NCT IDNCT07465783

SponsorCentre Hospitalier Universitaire de Saint Etienne

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Isabelle ROUCH, MD

(0)477127399 isabelle.rouch@chu-st-etienne.fr

View on ClinicalTrials.gov More Alzheimer Disease or Associated Disorder trials

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.