Evening Music-Based Intervention for Sleep and Behavior in Alzheimer's Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, interventional study uses a randomized, cluster-organized crossover design to compare a music-based intervention delivered by a therapist with an audiobook listening control in secure care units. Each participant experiences both conditions across two periods, with the order randomized at the unit level. The interventions consist of ten evening sessions per period, conducted in the participant’s living environment, and outcomes will be measured at baseline, during, and after each period using behavioral assessments and actigraphy. The study targets adults 60 and older with Alzheimer’s disease or related disorders and will analyze whether music improves sleep-related and behavioral parameters compared with audiobook listening.

Why it matters

Who can join: the full rules

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

Where it's running

• Saint-etienne hospital
  Saint-Etienne, France Recruiting

Study contacts

• Principal investigator: Isabelle ROUCH, MD — CHU de Saint-Etienne
• Study coordinator: Isabelle ROUCH, MD
• Email: isabelle.rouch@chu-st-etienne.fr
• Phone: (0)477127399

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.