Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Music intervention - passive listening, Audio books intervention - active listening.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease or Associated Disorder. Basic parameters: from 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Behavioral Music intervention - passive listening
Diffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening. - Behavioral 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 .
Primary outcome measures
- Sleep duration [Time frame: Days 1 to 51]
Secondary outcome measures (4)
- Sleep onset and nocturnal awakenings reduction [Time frame: Days 1 to 51]
- Daytime agitation reduction [Time frame: Days 1 to 51]
- Mood improvement [Time frame: Days 1 to 51]
- Falls number reduction [Time frame: Days 1 to 51]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
France · 1 center
- CHU de Saint-Etienne — Saint-Etienne
Identifiers
NCT: NCT07207642 · 25CH036 · 2025-A00468-41