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

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: Alzheimer Disease or Associated Disorder

Treatments: Behavioral: Audio books intervention - active listening; Behavioral: Music intervention - passive listening

Study type: Observational

Funder types: Other

Identifiers

NCT07207642

25CH036

2025-A00468-41 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 2 patient groups

Passive EXPERIMENT

Description:

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.

Treatment:

Behavioral: Music intervention - passive listening

Active EXPERIMENT

Description:

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.

Treatment:

Behavioral: Audio books intervention - active listening