Alzheimer Disease or Associated Disorder
Conditions
Keywords
Alzheimer's disease, Behavior disorder, Music intervention
Brief summary
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.
Detailed description
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.
Interventions
OTHERTest musicale intervention
listenning music
OTHERControle: audio book
listenning audio books
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Lyon Neuroscience Research Center (CRNL)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signature of consent by the patient's legal guardian obtained after providing information * Patients aged 60 and over who meet the diagnostic criteria for Alzheimer's disease and related disorders, including mainly: Lewy body disease, frontotemporal lobar degeneration, progressive supranuclear palsy, corticobasal degeneration, vascular encephalopathy, alcoholic dementia, primary progressive aphasia syndrome, posterior cortical atrophy syndrome (France Alzheimer, 2024). * Patient living in a secure care unit * If taking psychotropic drugs, they must have been stable for 3 months * If taking level 2 or 3 painkillers, they must have been stable for 1 month
Exclusion criteria
* Refusal to participate * Participation in a study on a drug/medical device/treatment technique that may affect sleep or behavior. * Highly sedated patients, * Patients with acute medical instability, * Patients with productive delusions, * Patients who have been in the unit for less than 1 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Music | 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. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sleep parameter (1) | hroughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up) | Change in sleep onset latency , assessed by actigraphy. |
| Daytime disruptive behaviors | Throughout all study periods (Days 1-60). | 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 |
| Falls | Throughout all study periods (Days 1-60) | Change in the number of falls recorded during each study period. |
| sleep parameter (2) | Throughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up) | number of nocturnal awakenings, assessed by actigraphy. |
Countries
France
Contacts
CONTACTIsabelle ROUCH, MD
CONTACTCéline BORG, PhD
PRINCIPAL_INVESTIGATORIsabelle ROUCH, MD
CHU de Saint-Etienne
Outcome results
None listed