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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00468-41 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Passive EXPERIMENT | Measurement of the effects of a personalised music listening session at bedtime (play-list) for 10 days. Each patient is his or her own control. Behavioural and actigraphic data are collected and compared before, during and after the intervention. |
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| Active EXPERIMENT | An intervention based on listening to audio books, led by a therapist for 10 evenings . Each patient is his or her own control and takes part in the entire experiment. Behavioural and actigraphic data are collected and compared before, during and after intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Music intervention - passive listening | Behavioral | Diffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sleep duration | Sleep duration will be measured by actigraphy (bracelet worn by the participants). | Days 1 to 51 |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep onset and nocturnal awakenings reduction | Sleep onset latency and number of nocturnal awakenings measured by actigraphy. | Days 1 to 51 |
| Daytime agitation reduction | Cohen-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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders, living in a Protected Living Unit (PLU) will be included.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Isabelle ROUCH, Md | Contact | (0)477127399 | +33 | isabelle.rouch@chu-st-etienne.fr |
| Céline BORG, PhD | Contact | (0)477127805 | +33 | celine.borg@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Isabelle ROUCH, Md | CHU de Saint-Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Saint-Etienne | Recruiting | Saint-Etienne | France | 42100 | France |
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| Audio books intervention - active listening | Behavioral | Dynamic audio book listening, akin to active listening while respecting the rhythm of the evening . This type of listening involves concentrating specifically . |
|
| Days 1 to 51 |
| Mood improvement | Caregiver questionnaire: category scale : for agitation and mood. | Days 1 to 51 |
| Falls number reduction | Fall questionnaire include in the caregiver questionnaire. | Days 1 to 51 |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D001523 | Mental Disorders |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
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