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ApathySENS'REMNCT07468305

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

A study testing Multisensory Virtual Reality Reminiscence Intervention in people with Apathy and Apathy in Dementia, run by Centre Hospitalier Universitaire de Nice at 2 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Apathy, Apathy in Dementia
What is being tested?
Multisensory Virtual Reality Reminiscence Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
2 sitesFrance
Study dates
Sep 2026to Aug 2027
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

  • "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"

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

France2 sites
  • CHU de Nice - Hôpital de Cimiez

    Nice, 06000

    Anne-Julie Vaillant-ciszewicz, +33615938590, vaillant-ciszewicz.aj@chu-nice.fr

  • EPHAD Villa de Rimiez

    Nice

    Said ATTAILIA, MD, +33489224200, SATTAILIA.RIMIEZ@LNA-SaNTE.COM

Other trials in France

About this study

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

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.

Read more

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.

Being tested
Multisensory Virtual Reality Reminiscence Intervention
Keywords
Neurocognitive disorders, apathy, dementia
Medical subject headings
Lethargy, Neurocognitive Disorders, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multisensory Virtual Reality Reminiscence InterventionBehavioural

    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

Study groups in NCT07468305
Study groupRoleWhat they receive
Multisensory Virtual Reality Reminiscence InterventionExperimentalNot described
Receives: Behavioral: Multisensory Virtual Reality Reminiscence Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at 12 months

Secondary outcomes (2)
  1. Change in apathy level measured by the Apathy Inventory

    The change in apathy is assessed using the Apathy Inventory (AI; Robert et al., 2002), a validated instrument for neurocognitive disorders. Three complementary versions are used: patient version (8 items, score range 0-32), caregiver version (18 items, score range 0-72), and informant version (18 items, score range 0-72). Items are rated from 0 (never) to 4 (very often). Lower scores indicate greater apathy, while higher scores reflect better motivation and engagement. No formal cut-off score is applied; changes are evaluated by comparing baseline and post-intervention scores across the three sources.

    Measured: at 12 months

  2. Tolerance of the intervention assessed by cybersickness symptoms

    Tolerance is assessed using the CyberSickness in Virtual Reality Questionnaire (CSQ-VR; Kourtesis et al., 2023), a validated instrument measuring discomfort related to virtual reality exposure. The questionnaire includes 20 items assessing symptoms such as nausea, dizziness, visual disturbance, disorientation, and fatigue. Each item is rated from 0 (none) to 4 (severe), providing a total score reflecting cybersickness severity. Higher scores indicate greater discomfort. No validated clinical cut-off is defined; tolerance is evaluated by comparing symptom severity across sessions and at the end of the intervention period. In addition, all adverse events related to VR use are systematically recorded.

    Measured: at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionFeb 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07468305
Sponsor's protocol ID
25-AOIP-05
Acronym
SENS'REM
Status last verified
May 2026
First submitted
9 Mar 2026
Last updated
26 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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