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

NCT07468305 | Not Yet Recruiting

• 1 other identifier: 25-AOIP-05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

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.

Conditions

Apathy; Apathy in Dementia

Keywords

Neurocognitive disorders; apathy; dementia

Outcome Measures

Primary Outcomes (1)

• Overall feasibility of the multisensory virtual reality reminiscence intervention in institutional settings

  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.

  at 12 months

Secondary Outcomes (2)

• Change in apathy level measured by the Apathy Inventory

  at 12 months

• Tolerance of the intervention assessed by cybersickness symptoms

  at 12 months

Study Arms (1)

Multisensory Virtual Reality Reminiscence Intervention

EXPERIMENTAL

Behavioral: Multisensory Virtual Reality Reminiscence Intervention

Interventions

Multisensory Virtual Reality Reminiscence Intervention BEHAVIORAL

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 combines visual immersion with auditory stimulation, olfactory cues, and, when appropriate, gustatory stimuli. During each session, participants are encouraged to express memories, emotions, and perceptions associated with the virtual experience. A trained investigator remains present throughout the session to ensure safety, provide support, and collect observational data. Sessions are adapted to the participant's tolerance and may be interrupted at any time. The intervention is designed to stim

Multisensory Virtual Reality Reminiscence Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• "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"

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (2)

CHU de Nice - Hôpital de Cimiez

Nice, 06000, France

Location

EPHAD Villa de Rimiez

Nice, France

Location

MeSH Terms

Conditions

Lethargy; Neurocognitive Disorders; Dementia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• Anne-Julie Vaillant-Ciszewicz, PhD

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Julie Vaillant-Ciszewicz, PhD

CONTACT

+33615938590; vaillant-ciszewicz.aj@chu-nice.fr

FRANCESCA FRESCURA

CONTACT

06.51.68.18.31; frescura.f@chu-nice.fr

Study Design

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

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 12, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)