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Clinical Trials in France / NCT07465783
Recruiting Not applicable

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

NCT07465783 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Phase
Not applicable
Started
2026-02-02
Last updated
2026-08-03

Condition(s) studied

Alzheimer Disease or Associated Disorder

Investigational drug(s) / intervention(s)

Test musicale interventionControle: audio book

Test musicale intervention: listenning music

Controle: audio book: listenning audio books

Study 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

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Music — 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.
    Changing in sleep duration, following an evening music-based intervention in older adults with Alzheimer's disease or related disorders living in a protected care unit (UVP), assessed by actigraphy

Trial sites (1)

FacilityCityRegionStatus
Saint-etienne hospital Saint-Etienne France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07465783 on ClinicalTrials.gov ↗ ← All trials in France