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MUSic Listening Impact on QUality of Life, Brain and Burnout of ALzheimer' Patients Informal Caregivers (MUSIQUAL+)

C

Caen University Hospital

Status

Not yet enrolling

Conditions

Alzheimer Dementia (AD)
Caregivers

Treatments

Behavioral: Neuropsychology assessment
Other: brain imaging examination
Behavioral: listening intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT07159542
24-0160
2024-A01480-47 (Registry Identifier)

Details and patient eligibility

About

Although life expectancy is increasing, the risk of dependence and/or loss of autonomy is increasing too with ageing. Alzheimer's disease affects many people and this kind of disease is constantly growing. Today, relatives of these sick people are increasingly taking on the role of carer to help them remain at home as long as possible. This situation of assistance has often a negative impact on the quality of life of the caregiver, which in some cases can lead to the caregiver burnout and increase the risk factors for developing pathological ageing. This situation can also damage the relationship and the quality of interactions between patient/caregiver dyad. Non-pharmacological therapies and the use of digital tools appear to be promising avenues to fight psychological distress and social isolation, but also to improve the quality and duration of homecare services, by promoting the autonomy of the patient. The MUSIQUAL+ study aims to evaluate the impact of music listening offered to caregivers, alone or with their sick relative, on the quality of life and the exhaustion felt by the caregiver. Three times 20-minute sessions a week of music listening at home through the use of a tablet application, for 12 weeks, will be proposed. In addition to the collection of subjective feelings of the caregivers, a neuropsychological evaluation of the patient and the caregiver will be carried out on 90 dyads divided. Finally, in order to better understand the cerebral mechanisms involved and to provide evidence of the effect of this intervention, an EEG recording will be made before and after the musical listening. This study proposes a therapeutic and preventive alternative to drug treatments and to the currently unsatisfactory support of patients and their caregivers in distress; its benefits will be assessed too.

Enrollment

90 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Native language: French

  • Medical, neurological, neuropsychological and neuroradiological depth in accordance with the criteria for inclusion and exclusion-specific population, that is to say:

    • Informal Caregivers: Being a carer for someone with neurodegenerative cognitive disorders (NCD), living at home, without memory complaints, normal performances compared to the age and the educational level for all tests of the diagnostic battery.
    • Patients with neurodegenerative cognitive disorders: presenting neurodegenerative cognitive disorders, have an identified informal caregiver.

Exclusion criteria

  • A chronic neurological, psychiatric, endocrine, hepatic or infectious complaint
  • A history of major disease (an uncontrolled diabetes, a lung, heart, metabolic, hematologic, endocrine disease or a severe cancer);
  • A medication that may interfere with memory or metabolic measures

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

90 participants in 3 patient groups

CONTROL
Active Comparator group
Description:
listening podcast (verbal) in dyads during 12 weeks
Treatment:
Behavioral: listening intervention
Other: brain imaging examination
Behavioral: Neuropsychology assessment
MUSIC
Active Comparator group
Description:
listening music during 12 weeks caregivers alone
Treatment:
Behavioral: listening intervention
Other: brain imaging examination
Behavioral: Neuropsychology assessment
MUSIC+
Experimental group
Description:
listening music in dyads during 12 weeks
Treatment:
Behavioral: listening intervention
Other: brain imaging examination
Behavioral: Neuropsychology assessment

Trial contacts and locations

1

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Central trial contact

Mathilde GROUSSARD

Data sourced from clinicaltrials.gov

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