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

March 9, 2026 updated by: Centre Hospitalier Universitaire de Saint Etienne

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Test musicale intervention
musicale intervention before night
Other: Test musicale intervention
listenning music
Active Comparator: Controle: audio book
listenning audio book with an experimenter
Other: Controle: audio book
listenning audio books

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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

Outcome Measure
Measure Description
Time Frame
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)
Change in sleep onset latency , assessed by actigraphy.
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).
Change in disruptive behaviors assessed using the Cohen-Mansfield Agitation Inventory (CMAI), a categorical agitation scale, (score 0 to 29, Low score : low or infrequent agitation ; High score : frequent or intense agitation
Throughout all study periods (Days 1-60).
Falls
Time Frame: Throughout all study periods (Days 1-60)
Change in the number of falls recorded during each study period.
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)
number of nocturnal awakenings, assessed by actigraphy.
Throughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Lyon Neuroscience Research Center (CRNL)

Investigators

  • Principal Investigator: Isabelle ROUCH, MD, CHU de Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 21, 2026

First Submitted That Met QC Criteria

March 9, 2026

First Posted (Actual)

March 12, 2026

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25CH211
  • ANSM (Other Identifier: 2025-A01697-42)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease or Associated Disorder

Clinical Trials on Test musicale intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe