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

NCT07207642 | Recruiting

• 2 other identifiers: 25CH0362025-A00468-41
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Keywords

Alzheimer's disease; Music intervention; Behavior disorder

Outcome Measures

Primary Outcomes (1)

• Sleep duration

  Sleep duration will be measured by actigraphy (bracelet worn by the participants).

  Days 1 to 51

Secondary Outcomes (4)

• Sleep onset and nocturnal awakenings reduction

  Days 1 to 51

• Daytime agitation reduction

  Days 1 to 51

• Mood improvement

  Days 1 to 51

• Falls number reduction

  Days 1 to 51

Study Arms (2)

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.

Behavioral: Music intervention - passive 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.

Behavioral: Audio books intervention - active listening

Interventions

Music intervention - passive listening BEHAVIORAL

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

Passive EXPERIMENT

Audio books intervention - active listening BEHAVIORAL

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

Active EXPERIMENT

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders, living in a Protected Living Unit (PLU) will be included.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, France, 42100, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Mental Disorders

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Study Officials

• Isabelle ROUCH, Md

  CHU de Saint-Etienne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isabelle ROUCH, Md

CONTACT

(0)477127399; isabelle.rouch@chu-st-etienne.fr

Céline BORG, PhD

CONTACT

(0)477127805; celine.borg@chu-st-etienne.fr

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: October 6, 2025
• Study Start: January 13, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)