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

NCT ID: NCT07207642

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-13
• Study Completion Date: 2028-02-29

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.

Conditions

Alzheimer Disease or Associated Disorder

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

Passive EXPERIMENT

Measurement of the effects of a personalised music listening session at bedtime (play-list) for 10 days. Each patient is his or her own control. Behavioural and actigraphic data are collected and compared before, during and after the intervention.

Music intervention - passive listening

Intervention Type: BEHAVIORAL

Diffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening.

Active EXPERIMENT

An intervention based on listening to audio books, led by a therapist for 10 evenings . Each patient is his or her own control and takes part in the entire experiment. Behavioural and actigraphic data are collected and compared before, during and after intervention.

Audio books intervention - active listening

Intervention Type: BEHAVIORAL

Dynamic audio book listening, akin to active listening while respecting the rhythm of the evening . This type of listening involves concentrating specifically .

Interventions

Music intervention - passive listening

Diffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening.

Intervention Type: BEHAVIORAL

Audio books intervention - active listening

Dynamic audio book listening, akin to active listening while respecting the rhythm of the evening . This type of listening involves concentrating specifically .

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Isabelle ROUCH, Md

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Etienne

Locations

CHU de Saint-Etienne

Saint-Etienne, France, France

Site Status: RECRUITING

Countries

France

Central Contacts

Isabelle ROUCH, Md

Role: CONTACT

isabelle.rouch@chu-st-etienne.fr

(0)477127399 ext. +33

Céline BORG, PhD

Role: CONTACT

celine.borg@chu-st-etienne.fr

(0)477127805 ext. +33

Facility Contacts

Isabelle ROUCH, Md

Role: primary

isabelle.rouch@chu-st-etienne.fr

(0)477127399 ext. +33

Céline BORG, PhD

Role: backup

celine.borg@chu-st-etienne.fr

(0)477127805 ext. +33

Other Identifiers

2025-A00468-41

Identifier Type: OTHER

Identifier Source: secondary_id

25CH036

Identifier Type: -

Identifier Source: org_study_id