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NCT07465783
Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)
Conditions: Alzheimer Disease or Associated Disorder
Sex: All
Ages: 60 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 48
Sponsor: Centre Hospitalier Universitaire de Saint Etienne
Location: Saint-etienne hospital Saint-Etienne
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
Source: ClinicalTrials.gov (NCT07465783). StuddyBuddy aggregates publicly available trial information.