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

Primary Purpose

Apathy in Dementia, Aged, Virtual Reality

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Casque Lumeen
Sponsored by
RIVAGES
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Apathy in Dementia

Eligibility Criteria

65 Years - 110 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Maison de retraite la PasserelleRecruiting
  • Maison de retraite l'arc en cielRecruiting
  • USLD Arcadie - CHU RouenRecruiting
  • EHPAD d'Enghien
  • EHPAD Louis Grassi
  • Hôpital Charles FoixRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

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.

Outcomes

Primary Outcome Measures

Tolerance of virtual reality sessions
No change in Simulator Sickness Questionnaire (SSQ), or maintenance of "none" and "slight" scores. There are 16 items, each item is rated with the scale from none, slight, moderate to severe. After some calculations you have 3 subscores : Computation of nausea (N), oculomotor r disturbance (O), disorientation (D), and total simulator sickness (TS) scores.
Effectiveness of virtual reality sessions on apathy symptoms
Decrease in apathy scores on the Apathy Inventory (IA) (NPI). IA clinician assessment (0 to 4 score) has to take into account several factors: useful observation points, Patient history and social environment, personality, Information coming from the caregiver, Patient's responses to the clinical domains, autonomy. A score equal or upper to 4 is pathological.
Effectiveness of virtual reality sessions on apathy symptoms
Decrease in apathy scores on the Neuropsychiatric Inventory (NPI), caregiver version. The NPI-ES is based on responses from a member of the healthcare team involved in the patient's care. Responses refer to behaviours that have been present over the past week or other well-defined during other well-defined periods (e.g. 1 month ago, or since the last assessment). Answers should be brief, and can be formulated as "yes" or "no". In clinical practice, the most relevant factor to consider is the frequency x severity score for each area (a score greater than 2 is pathological).

Secondary Outcome Measures

Security
no technical problems endangering the user during sessions, resulting in the session being stopped

Full Information

First Posted
July 20, 2023
Last Updated
September 18, 2023
Sponsor
RIVAGES
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1. Study Identification

Unique Protocol Identification Number
NCT06047522
Brief Title
Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders
Acronym
APATHIE_RV
Official Title
Benefit of Virtual Reality Headset Use on Apathy in Older Adults With Major Neurocognitive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2023 (Actual)
Primary Completion Date
January 3, 2024 (Anticipated)
Study Completion Date
January 3, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RIVAGES

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apathy in Dementia, Aged, Virtual Reality, Neurocognitive Disorders

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Casque Lumeen
Intervention Description
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.
Primary Outcome Measure Information:
Title
Tolerance of virtual reality sessions
Description
No change in Simulator Sickness Questionnaire (SSQ), or maintenance of "none" and "slight" scores. There are 16 items, each item is rated with the scale from none, slight, moderate to severe. After some calculations you have 3 subscores : Computation of nausea (N), oculomotor r disturbance (O), disorientation (D), and total simulator sickness (TS) scores.
Time Frame
through study completion, an average of 6 months
Title
Effectiveness of virtual reality sessions on apathy symptoms
Description
Decrease in apathy scores on the Apathy Inventory (IA) (NPI). IA clinician assessment (0 to 4 score) has to take into account several factors: useful observation points, Patient history and social environment, personality, Information coming from the caregiver, Patient's responses to the clinical domains, autonomy. A score equal or upper to 4 is pathological.
Time Frame
through study completion, an average of 6 months
Title
Effectiveness of virtual reality sessions on apathy symptoms
Description
Decrease in apathy scores on the Neuropsychiatric Inventory (NPI), caregiver version. The NPI-ES is based on responses from a member of the healthcare team involved in the patient's care. Responses refer to behaviours that have been present over the past week or other well-defined during other well-defined periods (e.g. 1 month ago, or since the last assessment). Answers should be brief, and can be formulated as "yes" or "no". In clinical practice, the most relevant factor to consider is the frequency x severity score for each area (a score greater than 2 is pathological).
Time Frame
through study completion, an average of 6 months
Secondary Outcome Measure Information:
Title
Security
Description
no technical problems endangering the user during sessions, resulting in the session being stopped
Time Frame
through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
110 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joël Belmin
Phone
0149594565
Email
j.belmin@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nathavy Um Din
Phone
0149594568
Email
livinglab.psga@gmail.com
Facility Information:
Facility Name
Maison de retraite la Passerelle
City
Larajasse
State/Province
Rhône
ZIP/Postal Code
69590
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Ott
Facility Name
Maison de retraite l'arc en ciel
City
Saint-Martin-en-Haut
State/Province
Rhône
ZIP/Postal Code
69850
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Ott
Facility Name
USLD Arcadie - CHU Rouen
City
Mont-Saint-Aignan
State/Province
Seine Maritime
ZIP/Postal Code
76130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Capolongo
Facility Name
EHPAD d'Enghien
City
Enghien-les-Bains
State/Province
Val d'Oise
ZIP/Postal Code
95880
Country
France
Individual Site Status
Active, not recruiting
Facility Name
EHPAD Louis Grassi
City
Presles
State/Province
Val d'Oise
ZIP/Postal Code
95590
Country
France
Individual Site Status
Active, not recruiting
Facility Name
Hôpital Charles Foix
City
Ivry-sur-Seine
State/Province
Val De Marne
ZIP/Postal Code
94200
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joël Belmin
Phone
0149594565
Email
j.belmin@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nathavy Um Din, MSc

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Each co-investigator coordinates his or her inclusions with the principal investigator, and sends him or her the data collected via secure messaging. The co-investigator is responsible for collating all the data.

Learn more about this trial

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

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