NCT07207642 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne |
| Condition | Alzheimer Disease or Associated Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-01-13 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2026-01-13 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Isabelle ROUCH, Md
PRINCIPAL INVESTIGATOR
CHU de Saint-Etienne
Frequently Asked Questions
Who can join the NCT07207642 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Alzheimer Disease or Associated Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07207642 currently recruiting?
Yes, NCT07207642 is actively recruiting participants. Contact the research team at isabelle.rouch@chu-st-etienne.fr for enrollment information.
Where is the NCT07207642 trial being conducted?
This trial is being conducted at Saint-Etienne, France.
Who is sponsoring the NCT07207642 clinical trial?
NCT07207642 is sponsored by Centre Hospitalier Universitaire de Saint Etienne. The principal investigator is Isabelle ROUCH, Md at CHU de Saint-Etienne. The trial plans to enroll 120 participants.
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