ClinicalTrials.gg
Not yet recruitingNCT07468305SENS'REMUpdated May 26, 2026

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

An interventional study of Multisensory Virtual Reality Reminiscence Intervention in Apathy and Apathy in Dementia, sponsored by Centre Hospitalier Universitaire de Nice. Not yet recruiting at 2 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.

Primary conditionDementiaRegistry: Neurocognitive DisordersReclassifiedWhy we changed it
Registry
Neurocognitive Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Dementia
Why
  1. The study's listed conditions name Dementia, a narrower term within Neurocognitive Disorders.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre Hospitalier Universitaire de Nice · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
65 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 128 studies in Dementia with a site in France — 25 open to participants now, 33 under way, 6 of them phase 3. Dementia · France.

Planned enrollment
91st of 92
10 · median 201
Started
2026
with 2 others
No phase
44 of 128
10 open now
Primary completion
2027-02
later than 12 of 32 live
Registered
125th of 128
by date
Lead sponsor
3 of 128
Centre Hospitalier Universitaire de Nice

Among the 128 studies in Dementia with a site in France, this one is the 91st largest by planned enrollment of the 92 interventional ones, is one of 3 that started in 2026, is one of 44 with no phase, reaches primary completion later than 12 of the 32 other live ones, and was the 125th registered.

By phase

128 studies; the count open now beside each. This study's row is marked.

No phasethis study44 · 10 open
Observational36 · 9 open
Phase 322 · 2 open
Phase 214 · 2 open
Phase 2/38 · 2 open
Phase 12 · 0 open
Phase 42 · 0 open

By the year they started

First in 2001; this study’s year is marked. 3 started in 2026.

Size and results

Median enrollment 201 across the 92 interventional studies, 308 across the 36 observational. Of the 85 that completed or were terminated, 18 (21%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 128 studies in Dementia with a site in France, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Apathy
  • Apathy in Dementia

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Keywords

  • Neurocognitive disorders
  • apathy
  • dementia
04

In context

Dementia Reclassified

2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.

This study's planned enrollment of 10 is below the median of 90 across 1,758 interventional studies indexed under Dementia.

Browse Dementia studies →

Lead sponsor

Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.

Compared within Dementia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neurocognitive Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (MoCA) score between 10 and 17
  • Affiliated with a social security or health insurance system
  • Medical approval for virtual reality exposure (no )
  • Ability to provide , or consent provided by a legal representative or trusted person when applicable

Exclusion criteria

Exclusion Criteria:

  • "Diagnosed psychiatric disorder according to 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 at any time during the study"
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

06

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    Multisensory Virtual Reality Reminiscence Intervention

    Behavioral: Multisensory Virtual Reality Reminiscence Intervention

Interventions

  • BehavioralMultisensory 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 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

07

What researchers measure

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.

    Time frame: at 12 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: at 12 months

08

Study locations

2 sites
09

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2027, 5 months later.

Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 5 months is below that.

Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2026
First posted
Mar 12, 2026
StartEst.
Sep 2026
Primary completionEst.
Feb 2027
CompletionEst.
Aug 2027
Last update
May 26, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 26, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07468305
Responsible party
Sponsor
First posted
Mar 12, 2026
Start date
Sep 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
May 26, 2026

Study contacts

Anne-Julie Vaillant-Ciszewicz, PhD
Contact
vaillant-ciszewicz.aj@chu-nice.fr
+33615938590
FRANCESCA FRESCURA
Contact
frescura.f@chu-nice.fr
06.51.68.18.31
Anne-Julie Vaillant-Ciszewicz, PhD
principal investigator · Centre Hospitalier Universitaire de Nice

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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