Tolerance for Using Virtual Reality With Subjects Living... | NCT04365829

Studies
Tolerance for Using Virtual Reality With Subjects Living in Accommodation Establishment for the Elderly Dependent (EHPAD)

NCT04365829

Sponsor

Gérond'if

Status

Completed

Last Update Posted

Jan 12, 2023Actual

Enrollment

33Actual

Phase

Not Applicable

Conditions

Anxiety Disorders
Residents of Retirement Home (EHPAD)

Interventions

virtual reality headset "Occulus GO"

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Feb 2, 2022Actual

Completion Date

May 15, 2022Actual

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 27, 2020

First Posted Date

Apr 28, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2023

Last Update Posted Date

Jan 12, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of this study is to assess the tolerance of the virtual environment in the elderly living in a nursing home (EHPAD). It will be evaluated by the cybersickness collection after each session (1 session every other day for a total of 3 sessions).

Detailed Description

The purpose of this muliticentric, interventional, uncontrolled study is to assess the tolerance of the virtual environment in the elderly living in a nursing home

subjects who fulfil the inclusion criteria and after signing the informed consent will benefit from three individual virtual reality (VR) sessions.

The sessions will be performed out with one day apart

An assessment of anxiety trait and well-being of each subject will be performed before the first session (D1) and after the third (D3).

An assessment of anxiety as a condition will be performed before and after each session.

Heart rate and blood pressure measurements will be made before, during and after each session.

At the end of each session, an evaluation of cybersickness will be performed. Feedback on the acceptability of the experience will be provided at the end of each session.

Each session will last 1 hour in total: the person will visualize a single scene of virtual reality presenting a natural environment of a duration of 7 minutes preceded by a time of introduction, evaluation and followed by a time dedicated to evaluations and maintenance.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Virtual reality	Experimental		Device: virtual reality headset "Occulus GO"

Interventions

Name	Type	Description	Arm Group Labels	Other Names
virtual reality headset "Occulus GO"	Device	Use of a virtual reality headset for one week at a frequency of 3 days per week (D1, D3 and D5). During each session (1 hour), the subject will visualize a scene of natural virtual environment (a garden, animals in the wild, a grand Canyon) lasting 7 min using an virtual reality headset "Occulus GO".

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Assess the tolerance of the virtual environment according Simulator sickness questionnaire		5 days

Secondary Outcomes

Measure	Description	Time Frame
Assessment of the trait and the state of anxiety according a psychological inventory "State-Trait Anxiety Inventory" scale (STAI-Y)	The State-Trait Anxiety Inventory (STAI-Y) is a psychological inventory based on a 4-point Likert scale. Higher scores are positively correlated with higher levels of anxiety.	5 Days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mini Mental State Examination (M.M.S.E) scale ≥ 20.
University of California, San Diego Brief Assessment of Capacity to Consent (UBACC) scale ≥ 12/20.
Living in Retirment Homes (EHPAD).
Good understanding of the French language.
Benefiting from a social security scheme.
Have read the newsletter and have consented to participate in the study by signing a written consent.

Exclusion Criteria:

History of epileptic seizures.
Taking antihypertensive, neuroleptic, tricyclic antidepressants or parkinsonian drugs
Psychiatric disorders (Schizophrenia, dissociative disorders, borderline states, paranoia).
Hypertension (unless it is stabilized due to the absence of a change in antihypertensive treatment in the last 3 months and without a notable episode of orthostatic hypotension reported).
Vestibular or cerebellar syndromes.
Subjects under legal protection (curatorship, tutorship and safeguard of justice).
Refusal to participate.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emmanuelle DURON, MD	Geriatric Department, Paul Brousse Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geriatric Department, Paul Brousse Hospital		Villejuif	IIe-de-France	94800	France