Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living

Not yet recruiting

• Conditions: Alzheimer Disease or Associated Disorder

• Registration Number: NCT07207642
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

As the Alzheimer's disease progresses, caregivers and family members often focus on behavioral difficulties. In response to crises, immediate actions tend to favor restraints, either through medication or physical means. This work aims to improve the management of behavioral disturbances in patients with Alzheimer's disease through musical interventions (group or individual), particularly in advanced stages of the disease, where medical and family resources are insufficient. The investigators approach prioritizes NTM over medication as a mean to improve patient well-being. To this end, they have designed a study. The study focuses on creating a conducive environment for sleep by incorporating ritualized, familiar music sessions supervised by nursing staff after meals. To conduct this study, the actigraphy will be used to analyze participants' behavior both day and night, complemented by questionnaires and clinical observations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-06-18
• Status Verified: 2025-10
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Study Start: 2025-11-01
• Primary Completion: 2027-11
• Study Completion: 2028-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Non-opposition of the patient's legal guardian.
• Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders.
• Patients living in a Protected Living Unit (PLU)
• If consuming psychotropic medications, they must have been stabilized for 3 months.
• If consuming level 2 or 3 analgesics, they must have been stabilized for 1 month.

Exclusion Criteria

• Refusal to participate.
• Participation in a study on a drug /medical device / care technique that could affect sleep or behavior during the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sleep duration	Days 1 to 51	Sleep duration will be measured by actigraphy (bracelet worn by the participants).

Secondary Outcome Measures

Name	Time	Method
Sleep onset and nocturnal awakenings reduction	Days 1 to 51	Sleep onset latency and number of nocturnal awakenings measured by actigraphy.
Daytime agitation reduction	Days 1 to 51	Cohen-Mansfield Agitation Inventory score, which assesses 29 items including: non-aggressive physical agitation (1-13), non-aggressive verbal agitation (14-17), physical agitation and aggression (18-26), and verbal agitation and aggression (27-29). A high score reflects intense agitation.
Mood improvement	Days 1 to 51	Caregiver questionnaire: category scale : for agitation and mood.
Falls number reduction	Days 1 to 51	Fall questionnaire include in the caregiver questionnaire.

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France, France