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ClinicalTrials.gov ID

NCT07468305

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

10Estimated

Last Update Posted

May 26, 2026Actual

Start Date

Sep 2026Estimated

Primary Completion Date

Feb 2027Estimated

Completion Date

Aug 2027Estimated

Official Title

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

Brief Summary

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.

• Apathy
• Apathy in Dementia

• Multisensory Virtual Reality Reminiscence Intervention

Ages Eligible for Study

Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• "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"

Primary Purpose

Supportive Care

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Centre Hospitalier Universitaire de NiceOTHER

SATTAILIA.RIMIEZ@LNA-SaNTE.COM+33489224200