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Recruiting NCT07465783

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

No phase Interventional Alzheimer Disease or Associated Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Test musicale intervention, Controle: audio book.
Who it may be relevant to
Registry conditions: Alzheimer Disease or Associated Disorder. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

This study will employ a randomized, cluster-organized, crossover design to compare the effects of a music-based intervention (TEST) with an audiobook listening intervention (CONTROL). Both interventions will be delivered by a therapist in the participants' living environment over ten evening sessions per intervention period. Each participant will serve as their own control and will be exposed to both intervention conditions. The sequence of intervention periods ("TEST followed by CONTROL" or "CONTROL followed by TEST") will be randomized at the cluster level within participating protected care units (UVP). Behavioral and actigraphic outcomes will be collected and analyzed at baseline, during, and after each intervention period.

Interventions

  • Other Test musicale intervention
    listenning music
  • Other Controle: audio book
    listenning audio books

Primary outcome measures

  • Music [Time frame: 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.]
Secondary outcome measures (4)
  • sleep parameter (1) [Time frame: hroughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up)]
  • Daytime disruptive behaviors [Time frame: Throughout all study periods (Days 1-60).]
  • Falls [Time frame: Throughout all study periods (Days 1-60)]
  • sleep parameter (2) [Time frame: Throughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Saint-etienne hospital — Saint-Etienne

Identifiers

NCT: NCT07465783 · 25CH211 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗