Sweet Night (Musical Diffusion by Caregivers ): Effects of Musical Diffusion by Caregivers on Sleep Onset and Behavioral Regulation in a Protected Living

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-opposition of the patient's legal guardian.

Patients aged 60 and over, meeting the diagnostic criteria for Alzheimer's disease and related disorders.

Patients living in a Protected Living Unit (PLU)

If consuming psychotropic medications, they must have been stabilized for 3 months.

Disqualifiers

Refusal to participate.

Participation in a study on a drug /medical device / care technique that could affect sleep or behavior during the study.

Trial population

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.

Trial design

Design model

Case-crossover

Time perspective

Prospective

Treatments tested in this trial

  • Music intervention - passive listening

    Behavioral

    Diffusion of familiar music in the bedrooms and living room before bedtime; passive and individual listening.

  • 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 .

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Passive EXPERIMENT1 intervention
Group B: Active EXPERIMENT1 intervention

Trial outcomes

Primary outcomes

1

Sleep duration

Sleep duration will be measured by actigraphy (bracelet worn by the participants).

Time frame
Days 1 to 51

Secondary outcomes

1

Sleep onset and nocturnal awakenings reduction

Sleep onset latency and number of nocturnal awakenings measured by actigraphy.

Time frame
Days 1 to 51
2

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.

Time frame
Days 1 to 51
3

Mood improvement

Caregiver questionnaire: category scale : for agitation and mood.

Time frame
Days 1 to 51
4

Falls number reduction

Fall questionnaire include in the caregiver questionnaire.

Time frame
Days 1 to 51

Other outcomes

Sponsors and contacts

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