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Effects of Musical Intervention by a Therapist (IMT) on Falling Asleep and Behavioral Regulation in a Secure Care Unit (SCU)

ConditionAlzheimer Disease or Associated Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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,

Trial design

Design model

Crossover

Treatments tested in this trial

  • Test musicale intervention

    Other intervention

    listenning music

  • Controle: audio book

    Other intervention

    listenning audio books

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Test musicale interventionExperimental treatment 1 intervention
Group B: Controle: audio bookActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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)
2

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).
3

Falls

Change in the number of falls recorded during each study period.

Time frame
Throughout all study periods (Days 1-60)
4

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

Lyon Neuroscience Research Center (CRNL)

Collaborator

Source ClinicalTrials.gov
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