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| ID | Type | Description | Link |
|---|---|---|---|
| ANSM | Other Identifier | 2025-A01818-41 |
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| Name | Class |
|---|---|
| Lyon Neuroscience Research Center (CRNL) | UNKNOWN |
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This is a prospective, multicenter study designed to evaluate the benefits of an evening music-based intervention on sundowning syndrome in patients with Alzheimer's disease or related disorders in a Protect lLife Unit setting.
This study will employ a randomized, cluster-organized, crossover design to compare the effects of a music-based intervention (TEST) with an audiobook listening intervention (CONTROL). Both interventions will be delivered by a therapist in the participants' living environment over ten evening sessions per intervention period. Each participant will serve as their own control and will be exposed to both intervention conditions. The sequence of intervention periods ("TEST followed by CONTROL" or "CONTROL followed by TEST") will be randomized at the cluster level within participating protected care units (UVP). Behavioral and actigraphic outcomes will be collected and analyzed at baseline, during, and after each intervention period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test musicale intervention | Experimental | musicale intervention before night |
|
| Controle: audio book | Active Comparator | listenning audio book with an experimenter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test musicale intervention | Other | listenning music |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Music | Changing in sleep duration, following an evening music-based intervention in older adults with Alzheimer's disease or related disorders living in a protected care unit (UVP), assessed by actigraphy | Baseline (Days 1-10); TEST intervention (Days 11-20); post-intervention follow-up (Days 21-40); CONTROL intervention (Days 41-50); post-control follow-up (Days 51-60). Outcomes assessed throughout all study periods. |
| Measure | Description | Time Frame |
|---|---|---|
| sleep parameter (1) | Change in sleep onset latency , assessed by actigraphy. | hroughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up) |
| Daytime disruptive behaviors |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|---|---|---|---|---|
| Saint-etienne hospital | Saint-Etienne | France |
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| Controle: audio book |
| Other |
listenning audio books |
|
Change in disruptive behaviors assessed using the Cohen-Mansfield Agitation Inventory (CMAI), a categorical agitation scale, (score 0 to 29, Low score : low or infrequent agitation ; High score : frequent or intense agitation |
| Throughout all study periods (Days 1-60). |
| Falls | Change in the number of falls recorded during each study period. | Throughout all study periods (Days 1-60) |
| sleep parameter (2) | number of nocturnal awakenings, assessed by actigraphy. | Throughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up) |
| 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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