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

NCT07159542 | Not Yet Recruiting DMC

• 2 other identifiers: 24-01602024-A01480-47
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Keywords

Caregivers; Music intervention; Alzheimer

Outcome Measures

Primary Outcomes (1)

• EEG phase lag index differences between group

  Functional connectivity (EEG phase lag index (PLI) in each frequency band) differences between group

  through study completion, an average of 12 weeks

Study Arms (3)

CONTROL

ACTIVE COMPARATOR

listening podcast (verbal) in dyads during 12 weeks

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

MUSIC

ACTIVE COMPARATOR

listening music during 12 weeks caregivers alone

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

MUSIC+

EXPERIMENTAL

listening music in dyads during 12 weeks

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

Interventions

listening intervention BEHAVIORAL

Music or podcast listening intervention

CONTROL; MUSIC; MUSIC+

Neuropsychology assessment BEHAVIORAL

Neuropsychology assessment

CONTROL; MUSIC; MUSIC+

brain imaging examination OTHER

EEG: recording of neural dynamic

CONTROL; MUSIC; MUSIC+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Native language: French
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Caen: lead

Study Sites (1)

PFRS Caen France

Caen, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Mathilde GROUSSARD

CONTACT

+332 31 56 01 25; mathilde.groussard@unicaen.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 8, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)