Clinical trial NCT05996250: Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects
Official title: Tolerance of an Immersive Virtual Reality Task Evaluating the Spatial Memory of Elderly Subjects and the Effects of Age, Gender and Level of Education on Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Participants
Keywords: Virtual reality
ageing
spatial memory
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 84
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Spatial navigation is a high-level cognitive function allowing animals and humans to orient and move in space by constructing a mental representation of the environment. This function has been identified as one of the very first to be affected by Alzheimer's disease, including at the early stages, before the appearance of other mnesic disorders that the latter causes, such as those of episodic memory. However, the neuropsychological tests currently used in the diagnosis of cognitive disorders do not allow effective assessment of spatial memory impairment, in particular because it is impractical to offer spatial orientation tasks in a consulting room. In this context, virtual reality offers very interesting perspectives: it makes it possible to create controlled environments to assess spatial memory, without leaving the place of consultation.

Before being able to test its possible diagnostic efficacy, it is imperative to test the feasibility as well as the reliability of this type of task on an elderly population with no cognitive impairment. The data currently available on immersion tolerance in virtual reality mainly concern young people aged 18 to 35 and little data is available concerning the elderly or very old.

If this task correctly assesses spatial navigation abilities, this study should find the effects of age and sex usually observed.

The aim of this study is to assess the tolerance of an immersive virtual reality task evaluating the spatial memory of elderly subjects and the effects of age, gender and level of education on performance.


Eligibility criteria: Inclusion Criteria:

* Participant aged 60 to 85
* Participant affiliated or entitled to a social security scheme
* Recruited participants must have been informed and consented in writing

Exclusion Criteria:

* Participant with a diagnosis of cognitive impairment
* Severe, progressive or unstable pathology whose nature may interfere with the evaluation variables (epilepsy, psychiatric or psychotic disorders in the acute phase, visual hallucinations, acute infection, lack of sleep)
* Participant equipped with a pacemaker
* Burns or sores on the upper part of the face or on the scalp
* Consumption of toxic substances that can influence cognitive performance
* Deafness or blindness that may compromise participant assessment or completion of tasks and scales
* Participant under guardianship or curatorship or legal safeguard
* Participant refusing to use an immersive virtual reality tool
* Criterion for stopping the procedure under study: stopping the virtual reality task due to the participant's simulator sickness.
* Montreal Cognitive Assessment (MOCA) score less than 26
* MacNair Subjective Complaint Scale score greater than 16
* AGGIR score (Autonomy, Gerontology Group Iso Resources) less than 5

Primary outcomes:
measure: Sickness Simulator Questionnaire (SSQ) score
timeFrame: The sickness simulator scale is assessed immediately after the immersive virtual reality task.
Secondary outcomes:
measure: Time to complete the task in immersive virtual reality according to the age of the participants
timeFrame: through study completion, 1 year
measure: Time to complete the task in immersive virtual reality (in seconds) according to the gender of participants (male or female)
timeFrame: through study completion, 1 year
measure: Time to complete the task in immersive virtual reality according to the number of years of study
timeFrame: through study completion, 1 year
measure: Raw score on the Wechsler Memory Scale-III (MEM III) Spatial Memory subtest
timeFrame: through study completion, 1 year
Other outcomes:
Locations:
city: Villeurbanne
country: France
facility: Charpennes Geriatric Hospital, Lyon University Hospital
Study officials:
References: