Evening caregiver-led music sessions to help sleep and behavior in people with Alzheimer’s in protected living
Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living
This project will test whether ritualized, familiar music sessions led by caregivers after meals help people with Alzheimer's in a protected living unit fall asleep faster and have fewer behavioral problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne, France) |
| Trial ID | NCT07207642 on ClinicalTrials.gov |
What this trial studies
This is an observational, single-site program conducted at a protected living unit where nursing staff lead ritualized familiar music sessions after meals, using either passive music listening or audiobooks. Participants will be monitored continuously with wrist actigraphy to capture daytime and nighttime activity patterns, supplemented by questionnaires and clinical observations of behavior. The protocol targets residents with advanced Alzheimer's who have limited medical or family resources, emphasizing non-pharmacologic music approaches over medication. Medication stability criteria for psychotropics and strong analgesics are required to limit confounding effects on sleep and behavior.
Who should consider this trial
Good fit: Ideal candidates are residents aged 60 or older with Alzheimer's disease or related disorders living in a protected living unit who have guardian consent and stable psychotropic or level 2/3 analgesic regimens per the protocol.
Not a fit: Patients who refuse to participate, who are enrolled in other studies that affect sleep or behavior, or whose symptoms are driven by acute untreated medical problems may not benefit from this program.
Why it matters
Potential benefit: If successful, this approach could reduce sleep-onset delays and nighttime agitation, potentially lowering reliance on sedative medications or physical restraints and improving daily comfort.
How similar studies have performed: Previous research on music therapy in dementia has commonly shown reductions in agitation and improved mood, but evidence specifically showing improved sleep onset in advanced Alzheimer's is limited and mixed.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Saint-Etienne, France
- CHU de Saint-Etienne — Saint-Etienne, France, France (Recruiting)
Study contacts
- Principal investigator: Isabelle ROUCH, Md — CHU de Saint-Etienne
- Study coordinator: Isabelle ROUCH, Md
- Email: isabelle.rouch@chu-st-etienne.fr
- Phone: (0)477127399
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.