Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders

NCT ID: NCT06047522

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-03

Study Completion Date

2024-01-03

Brief Summary

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The goal of this clinical trial is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders. The main questions it aims to answer are:

* Does virtual reality have an impact on symptoms of apathy in the elderly?
* Is virtual reality well tolerated by the elderly? Participants will benefit from a 3-session virtual reality headset program with a healthcare professional. They will have one session per week for 3 weeks. They will be observed by another professional, who will complete observation grids on apathy, engagement in activity and tolerance of the virtual reality headset.

There is not a comparison group: Researchers will compare the scores before and after the intervention: the participant will be his own control.

Detailed Description

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This study is a multicenter interventional exploratory study in two nursing homes and a geriatric long-term care service. Thirty patients will be included. They will be recruited from residents of the long-term care departments of two hospitals, and 4 nursing homes.

A pre- and post-intervention comparison will be made by assessing apathy using the apathy inventory and the neuropsychiatric inventory in the care team version. A comparison of participants' engagement will be carried out through ecological observation of the interventions. This will be objectivized by the Caregiver Interaction Behavior Scale (ECPAI) before the immersion program, and during the first and third virtual reality sessions. An ECPAI scale taken during a conventional animation prior to the program will establish a baseline state for the participant.

The main goal is to verify that virtual reality is tolerably compatible with apathetic pathologies in patients and residents with major neurocognitive disorders.

Conditions

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Apathy in Dementia Aged Virtual Reality Neurocognitive Disorders

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

The participant will benefit from three immersion sessions with the virtual reality headset, either individually or in a group session, accompanied by a team member trained in the use of the headset (psychomotrician, occupational therapist, doctor, psychologist, facilitator). At each session, the scale of observed emotions and the cybermalaise questionnaire will be completed (T1, T2, T3). At sessions 1 (T1) and 3 (T3), the investigator will administer the ECPAI behavior scale.

Group Type EXPERIMENTAL

Casque Lumeen

Intervention Type DEVICE

Participants will take part in virtual reality sessions via headset. They will benefit from a before/after evaluation, and a 3-week intervention where they will have 1 virtual reality session per week.

Interventions

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Casque Lumeen

Participants will take part in virtual reality sessions via headset. They will benefit from a before/after evaluation, and a 3-week intervention where they will have 1 virtual reality session per week.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Persons over 65 years of age
* Persons living in nursing homes or hospitalized in long-term care
* Persons with correct vision or vision corrected by glasses
* People with no hearing problems, or with hearing loss corrected by a hearing aid
* Person with a major neurocognitive disorder
* Person with a Mini Mental State Examination (MMSE) cognitive score \<26
* Individuals with documented apathy

Exclusion Criteria

* Person with a history of epilepsy
* Persons wearing a pacemaker
* Person with open wounds of the face or skull
* Disabling headache or neck pain
* Person at the immediate end of life or in active palliative care
* Person with a contagious disease
* People who are bedridden or unable to get into a wheelchair
* Persons with severe neurological impairment
* Person with severe behavioral disorders endangering self or staff
* Persons unable to give oral consent
Minimum Eligible Age

65 Years

Maximum Eligible Age

110 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RIVAGES

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Maison de retraite la Passerelle

Larajasse, Rhône, France

Site Status RECRUITING

Maison de retraite l'arc en ciel

Saint-Martin-en-Haut, Rhône, France

Site Status RECRUITING

USLD Arcadie - CHU Rouen

Mont-Saint-Aignan, Seine Maritime, France

Site Status RECRUITING

EHPAD d'Enghien

Enghien-les-Bains, Val d'Oise, France

Site Status ACTIVE_NOT_RECRUITING

EHPAD Louis Grassi

Presles, Val d'Oise, France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Charles Foix

Ivry-sur-Seine, Val De Marne, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Joël Belmin

Role: CONTACT

0149594565

Nathavy Um Din

Role: CONTACT

0149594568

Facility Contacts

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Lionel Ott

Role: primary

Lionel Ott

Role: primary

Laura Capolongo

Role: primary

Joël Belmin

Role: primary

0149594565

Other Identifiers

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2021-A02814-37

Identifier Type: -

Identifier Source: org_study_id

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