NCT07465783 Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)
| NCT ID | NCT07465783 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Alzheimer Disease or Associated Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-02-02 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 48 participants in total. It began in 2026-02-02 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Isabelle ROUCH, MD
PRINCIPAL INVESTIGATOR
CHU de Saint-Etienne
Frequently Asked Questions
Who can join the NCT07465783 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Alzheimer Disease or Associated Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07465783 currently recruiting?
Yes, NCT07465783 is actively recruiting participants. Contact the research team at isabelle.rouch@chu-st-etienne.fr for enrollment information.
Where is the NCT07465783 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT07465783 clinical trial?
NCT07465783 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Isabelle ROUCH, MD at CHU de Saint-Etienne. The trial plans to enroll 48 participants.
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