NCT07465783 · RECRUITING
Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)
This study tests whether an evening session of music led by a therapist helps people with Alzheimer's or related dementias fall asleep more easily and feel calmer at night. It is compared with listening to an audio book. It is not a drug trial. Phase does not apply, since it studies a care approach, not a medicine.
You may qualify if
- 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
You're excluded if
- 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
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 2026-08-03