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Recruiting Observational

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

NCT07207642 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2026-01-13
Last updated
2026-01-26

Condition(s) studied

Alzheimer Disease or Associated Disorder

Investigational drug(s) / intervention(s)

Music intervention - passive listeningAudio books intervention - active listening

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

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 .

Study 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.

Eligibility

Sex
ALL
Min age
60 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Sleep duration — Days 1 to 51
    Sleep duration will be measured by actigraphy (bracelet worn by the participants).

Trial sites (1)

FacilityCityRegionStatus
CHU de Saint-Etienne Saint-Etienne France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07207642 on ClinicalTrials.gov ↗ ← All trials in France