SENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: a Pilot Study

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое Multisensory Virtual Reality Reminiscence Intervention
  Participants receive a personalized multisensory reminiscence therapy program delivered through immersive virtual reality. Each participant attends one individual session per week for six consecutive weeks. Sessions last between 30 and 60 minutes and are conducted in a quiet room within the nursing home or long-term care unit. The virtual environments are selected according to each participant's life history and personal memories, such as familiar places or meaningful contexts. The intervention

Первичные конечные точки

• Overall feasibility of the multisensory virtual reality reminiscence intervention in institutional settings [Срок оценки: at 12 months]

Вторичные конечные точки (2)

• Change in apathy level measured by the Apathy Inventory [Срок оценки: at 12 months]
• Tolerance of the intervention assessed by cybersickness symptoms [Срок оценки: at 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• "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"

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Франция · 2 центра

• CHU de Nice - Hôpital de Cimiez — Nice
• EPHAD Villa de Rimiez — Nice

Идентификаторы

NCT: NCT07468305 · 25-AOIP-05

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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