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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04327778
Other study ID # 18-AOI-09
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2020
Est. completion date August 2021

Study information

Verified date April 2020
Source Centre Hospitalier Universitaire de Nice
Contact Hakima LABSI, Project manager
Phone 0033492034504
Email labsi.h@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Alzheimer disease is the most common neurodegenerative brain disease that causes cognitive impairment in the elderly but also behavioral and psychological symptoms. Among these symptoms, agitation is one of the most dangerous because it put the patient and their caregivers in danger. Sleep disorders can be the cause of many psychiatric symptoms leading directly or indirectly to agitation. Music therapy is the non-drug therapy which has been shown to be the most effective in managing agitation and sleep disorders. With the MAGE protocol, the investigators propose to take care of behavioral disorders in severe Alzheimer patients living in nursing home through sequences of music therapy (stimulation, relaxation) automatically initiated by an actigraph that will detect sleep disorders. These subjects will be exposed for 2 weeks over a month. Behavioral and sleep disorders will be evaluated objectively by actigraphy but also by standardized scales, as the others neuropsychiatric symptoms found classically in this disease. Thanks to this project, the investigators hope to improve the quality of life of these patients by preventing them from putting themselves in danger, by reducing their neuropsychiatric symptoms and their use of medication, which has often deleterious side effect and also by reducing the workload of caregivers.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 20
Est. completion date August 2021
Est. primary completion date April 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Age = 60 years old

- Male or Female

- Patients with a diagnosis of Alzheimer disease according to the criteria of NINCDS-ADRDA or typical or atypical Alzheimer disease

- MMSE < 20

- Patient residing in nursing home

- Voluntary, written and informed consent of the patient himself or its legal representative (guardian/curator)

- Affiliation to a social security system

Exclusion Criteria:

- Prescription of a new psychotropic treatment (hypnotic, anxiolytic, antidepressant, antipsychotic) in week prior to the evaluation

- Hearing loss preventing the patient from responding perfectly to the therapeutic solutions provided

Study Design


Intervention

Procedure:
Music Therapy
Automate music therapy every two weeks

Locations

Country Name City State
France CHU de Nice Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neuropsychiatric tests scores NeuroPsychiatric Inventory before exposure and at the end of each exposure, score from 0 to 120 At 3 months
Primary Nightly agitation The number of movements of the patient by the actigraphy, before exposure and at the end of each exposure At 3 month
Secondary Number of falls Number of falls by actigraphy At 3 months
Secondary Sleeping troubles Hours of sleep by actigraphy At 3 months
Secondary Rate of anxiety Anxiety rate measured by taking anxiolytic drugs At 3 months
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