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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07207642
Acronym
Sweet nightMDC
Enrollment
120
Registered
2025-10-06
Start date
2026-01-13
Completion date
2028-02-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease or Associated Disorder

Keywords

Alzheimer's disease, Music intervention, Behavior disorder

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.

Interventions

BEHAVIORALMusic intervention - passive listening

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

BEHAVIORALAudio 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 .

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Sleep durationDays 1 to 51Sleep duration will be measured by actigraphy (bracelet worn by the participants).

Secondary

MeasureTime frameDescription
Sleep onset and nocturnal awakenings reductionDays 1 to 51Sleep onset latency and number of nocturnal awakenings measured by actigraphy.
Daytime agitation reductionDays 1 to 51Cohen-Mansfield Agitation Inventory score, which assesses 29 items including: non-aggressive physical agitation (1-13), non-aggressive verbal agitation (14-17), physical agitation and aggression (18-26), and verbal agitation and aggression (27-29). A high score reflects intense agitation.
Mood improvementDays 1 to 51Caregiver questionnaire: category scale : for agitation and mood.
Falls number reductionDays 1 to 51Fall questionnaire include in the caregiver questionnaire.

Countries

France

Contacts

CONTACTIsabelle ROUCH, Md
isabelle.rouch@chu-st-etienne.fr(0)477127399
CONTACTCéline BORG, PhD
celine.borg@chu-st-etienne.fr(0)477127805
PRINCIPAL_INVESTIGATORIsabelle ROUCH, Md

CHU de Saint-Etienne

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026