SENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: Feasibility of Multi-Sensory Reminiscence in Virtual Reality on Apathy in Elderly People With Cognitive Disorders in Nursing Homes and Long-Term Care Units
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Overall feasibility of the multisensory virtual reality reminiscence intervention in institutional settings
研究概览
简要总结
SENS'REM is a pilot feasibility study evaluating a new non-drug therapeutic program based on multisensory reminiscence using immersive virtual reality in older adults living in nursing homes or long-term care units who present cognitive impairment and apathy.
Apathy is a frequent symptom in people with neurocognitive disorders. It is characterized by a loss of motivation, reduced interest in activities, and decreased emotional engagement. Apathy strongly affects quality of life, social interactions, and participation in care, and current drug treatments have limited effectiveness. For this reason, non-pharmacological approaches are increasingly recommended.
The SENS'REM program combines virtual reality with personalized multisensory stimulation (visual, auditory, olfactory and gustatory) to help participants relive meaningful autobiographical memories in an immersive and emotionally engaging environment. Each participant receives one session per week for six weeks. The content of the sessions is adapted to the individual life history of each participant.
The primary objective of this study is to evaluate the feasibility of implementing this program in institutional settings, including recruitment, organization, technical aspects, and participant adherence. Secondary objectives include evaluating changes in apathy, quality of life, cognitive functioning, social engagement, participant satisfaction, and the tolerance of the intervention.
The main hypothesis of the study is that a personalized multisensory virtual reality reminiscence program is feasible in nursing home and long-term care settings and may contribute to a reduction in apathy and an improvement in engagement and well-being among older adults with cognitive impairment.
This pilot study will provide essential preliminary data to optimize the intervention and prepare a future larger comparative clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 70 years or older
- •Living in a nursing home (EHPAD) or long-term care unit (USLD) for at least 3 months
- •Sufficient French language ability to understand the study procedures
- •Presence of apathy confirmed by a positive score on the Apathy Inventory
- •Moderate cognitive impairment documented by a Montreal Cognitive Assessment (MoCA) score between 10 and 17
- •Affiliated with a social security or health insurance system
- •Medical approval for virtual reality exposure (no contraindication)
- •Ability to provide informed consent, or consent provided by a legal representative or trusted person when applicable
排除标准
- •"Diagnosed psychiatric disorder according to DSM-5 criteria (e.g., schizophrenia, bipolar disorder)
- •Severe or acute behavioral disturbances incompatible with study participation
- •Neurological comorbidities incompatible with virtual reality use (e.g., Lewy body disease, history of epilepsy)
- •Severe sensory impairment (vision, hearing, or olfaction) preventing participation
- •Known susceptibility to cybersickness based on the CyberSickness in Virtual Reality Questionnaire (CSQ-VR)
- •Presence of a cardiac pacemaker incompatible with virtual reality headset use
- •Withdrawal of informed consent at any time during the study"
研究组 & 干预措施
Multisensory Virtual Reality Reminiscence Intervention
干预措施: Multisensory Virtual Reality Reminiscence Intervention (Behavioral)
结局指标
主要结局
Overall feasibility of the multisensory virtual reality reminiscence intervention in institutional settings
时间窗: at 12 months
Feasibility is assessed through functional, organizational, technological, and recruitment indicators. Functional feasibility is defined as the proportion of participants completing at least 50% of planned sessions (minimum 3 of 6 sessions). Organizational feasibility includes the proportion of sessions conducted as scheduled, and the frequency and reasons for postponed or cancelled sessions. Technological feasibility evaluates the availability and proper functioning of virtual reality equipment, including hardware or software failures and technical issues. Recruitment feasibility is assessed by the number of screened participants, the number eligible, and the proportion providing informed consent. No standardized scale is used; feasibility is described using descriptive quantitative indicators.
次要结局
- Change in apathy level measured by the Apathy Inventory(at 12 months)
- Tolerance of the intervention assessed by cybersickness symptoms(at 12 months)