Clinical trial Recruiting at 1 site Observational Ages 60 and up

Evening caregiver-led music sessions to help sleep and behavior in people with Alzheimer’s in protected living

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

Run by Centre Hospitalier Universitaire de Saint Etienne · NCT07207642 · Data updated 2026-11-12

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.

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Quick facts

Study typeObservational
Ages60 Years and up
SexAll
Enrollment120 (estimated)
SponsorCentre Hospitalier Universitaire de Saint Etienne
Academic / other
Locations1 site (Saint-Etienne, France)
StatusRecruiting
StartedJanuary 13, 2026
Main results expectedNovember 2027
Study endsFebruary 2028
Registry record updatedJanuary 26, 2026
Trial IDNCT07207642 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • CHU de Saint-Etienne
    Saint-Etienne, France, France
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.