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临床试验/NCT07159542
NCT07159542尚未招募不适用

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

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
90
试验地点
1
主要终点
EEG phase lag index differences between group

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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

研究组 & 干预措施

CONTROL

Active Comparator

listening podcast (verbal) in dyads during 12 weeks

干预措施: listening intervention (Behavioral)

CONTROL

Active Comparator

listening podcast (verbal) in dyads during 12 weeks

干预措施: Neuropsychology assessment (Behavioral)

CONTROL

Active Comparator

listening podcast (verbal) in dyads during 12 weeks

干预措施: brain imaging examination (Other)

MUSIC

Active Comparator

listening music during 12 weeks caregivers alone

干预措施: listening intervention (Behavioral)

MUSIC

Active Comparator

listening music during 12 weeks caregivers alone

干预措施: Neuropsychology assessment (Behavioral)

MUSIC

Active Comparator

listening music during 12 weeks caregivers alone

干预措施: brain imaging examination (Other)

MUSIC+

Experimental

listening music in dyads during 12 weeks

干预措施: listening intervention (Behavioral)

MUSIC+

Experimental

listening music in dyads during 12 weeks

干预措施: Neuropsychology assessment (Behavioral)

MUSIC+

Experimental

listening music in dyads during 12 weeks

干预措施: brain imaging examination (Other)

结局指标

主要结局

EEG phase lag index differences between group

时间窗: through study completion, an average of 12 weeks

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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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