Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 3:32 AM
Study NCT ID:
NCT07468305
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-13
First Post:
2026-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053609', 'term': 'Lethargy'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2027-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-12', 'studyFirstSubmitDate': '2026-03-09', 'studyFirstSubmitQcDate': '2026-03-09', 'lastUpdatePostDateStruct': {'date': '2026-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall feasibility of the multisensory virtual reality reminiscence intervention in institutional settings', 'timeFrame': 'at 12 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Change in apathy level measured by the Apathy Inventory', 'timeFrame': 'at 12 months', 'description': '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.'}, {'measure': 'Tolerance of the intervention assessed by cybersickness symptoms', 'timeFrame': 'at 12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Neurocognitive disorders', 'apathy', 'dementia'], 'conditions': ['Apathy', 'Apathy in Dementia']}, 'descriptionModule': {'briefSummary': "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.\n\nApathy 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.\n\nThe 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.\n\nThe 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.\n\nThe 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.\n\nThis pilot study will provide essential preliminary data to optimize the intervention and prepare a future larger comparative clinical trial."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women aged 70 years or older\n* Living in a nursing home (EHPAD) or long-term care unit (USLD) for at least 3 months\n* Sufficient French language ability to understand the study procedures\n* Presence of apathy confirmed by a positive score on the Apathy Inventory\n* Moderate cognitive impairment documented by a Montreal Cognitive Assessment (MoCA) score between 10 and 17\n* Affiliated with a social security or health insurance system\n* Medical approval for virtual reality exposure (no contraindication)\n* Ability to provide informed consent, or consent provided by a legal representative or trusted person when applicable\n\nExclusion Criteria:\n\n* "Diagnosed psychiatric disorder according to DSM-5 criteria (e.g., schizophrenia, bipolar disorder)\n* Severe or acute behavioral disturbances incompatible with study participation\n* Neurological comorbidities incompatible with virtual reality use (e.g., Lewy body disease, history of epilepsy)\n* Severe sensory impairment (vision, hearing, or olfaction) preventing participation\n* Known susceptibility to cybersickness based on the CyberSickness in Virtual Reality Questionnaire (CSQ-VR)\n* Presence of a cardiac pacemaker incompatible with virtual reality headset use\n* Withdrawal of informed consent at any time during the study"'}, 'identificationModule': {'nctId': 'NCT07468305', 'acronym': "SENS'REM", 'briefTitle': "SENS'REM - SENSoriality and Multi-Sensory Emotional Reminiscences: a Pilot Study", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': "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", 'orgStudyIdInfo': {'id': '25-AOIP-05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multisensory Virtual Reality Reminiscence Intervention', 'interventionNames': ['Behavioral: Multisensory Virtual Reality Reminiscence Intervention']}], 'interventions': [{'name': 'Multisensory Virtual Reality Reminiscence Intervention', 'type': 'BEHAVIORAL', 'description': "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", 'armGroupLabels': ['Multisensory Virtual Reality Reminiscence Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Anne-Julie Vaillant-ciszewicz', 'role': 'CONTACT', 'email': 'vaillant-ciszewicz.aj@chu-nice.fr', 'phone': '+33615938590'}], 'facility': 'CHU de Nice - Hôpital de Cimiez', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'city': 'Nice', 'country': 'France', 'contacts': [{'name': 'Said ATTAILIA, MD', 'role': 'CONTACT', 'email': 'SATTAILIA.RIMIEZ@LNA-SaNTE.COM', 'phone': '+33489224200'}], 'facility': 'EPHAD Villa de Rimiez', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Anne-Julie Vaillant-Ciszewicz, PhD', 'role': 'CONTACT', 'email': 'vaillant-ciszewicz.aj@chu-nice.fr', 'phone': '+33615938590'}, {'name': 'FRANCESCA FRESCURA', 'role': 'CONTACT', 'email': 'frescura.f@chu-nice.fr', 'phone': '06.51.68.18.31'}], 'overallOfficials': [{'name': 'Anne-Julie Vaillant-Ciszewicz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}