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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
48
listenning music
listenning audio books
Saint-etienne hospital
Saint-Etienne, France
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
Time frame: 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.
sleep parameter (1)
Change in sleep onset latency , assessed by actigraphy.
Time frame: hroughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up)
Daytime disruptive behaviors
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
Time frame: Throughout all study periods (Days 1-60).
Falls
Change in the number of falls recorded during each study period.
Time frame: Throughout all study periods (Days 1-60)
sleep parameter (2)
number of nocturnal awakenings, assessed by actigraphy.
Time frame: Throughout all study periods (Days 1-60, including baseline, TEST intervention, post-TEST follow-up, CONTROL intervention, post-CONTROL follow-up)
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