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

NCT ID: NCT07159542

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-30
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Alzheimer Dementia (AD); Caregivers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

CONTROL

listening podcast (verbal) in dyads during 12 weeks

Group Type: ACTIVE_COMPARATOR

listening intervention

Intervention Type: BEHAVIORAL

Music or podcast listening intervention

Neuropsychology assessment

Intervention Type: BEHAVIORAL

Neuropsychology assessment

brain imaging examination

Intervention Type: OTHER

EEG: recording of neural dynamic

MUSIC

listening music during 12 weeks caregivers alone

Group Type: ACTIVE_COMPARATOR

listening intervention

Intervention Type: BEHAVIORAL

Music or podcast listening intervention

Neuropsychology assessment

Intervention Type: BEHAVIORAL

Neuropsychology assessment

brain imaging examination

Intervention Type: OTHER

EEG: recording of neural dynamic

MUSIC+

listening music in dyads during 12 weeks

Group Type: EXPERIMENTAL

listening intervention

Intervention Type: BEHAVIORAL

Music or podcast listening intervention

Neuropsychology assessment

Intervention Type: BEHAVIORAL

Neuropsychology assessment

brain imaging examination

Intervention Type: OTHER

EEG: recording of neural dynamic

Interventions

listening intervention

Music or podcast listening intervention

Intervention Type: BEHAVIORAL

Neuropsychology assessment

Neuropsychology assessment

Intervention Type: BEHAVIORAL

brain imaging examination

EEG: recording of neural dynamic

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Caen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PFRS Caen France

Caen, , France

Countries

France

Central Contacts

Mathilde GROUSSARD

Role: CONTACT

mathilde.groussard@unicaen.fr

+332 31 56 01 25

Other Identifiers

2024-A01480-47

Identifier Type: REGISTRY

Identifier Source: secondary_id

24-0160

Identifier Type: -

Identifier Source: org_study_id