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REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders (REMINISCENCES)

Primary Purpose

Alzheimer Disease, Mood Disorders, Virtual Reality

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
virtual reality session
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease

Eligibility Criteria

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

Inclusion Criteria:

  • Male or female aged 65 or older
  • Accompanied in day care or in the geriatric structure of the CHU of Nice (EHPAD-USLD)
  • Mild to moderate cognitive impairment
  • Diagnostic criteria for Alzheimer's disease, NINCDS-ADRDA probably,
  • Positive score on at least one of the following rating scales :
  • NPI-ES depression/dysphoria and anxiety items + GDS 15 Patients
  • IA caregiver = 2 on one of 2 dimensions + IA patient = 2 on one of 2 dimensions

Exclusion Criteria:

  • Diagnosed psychiatric pathology
  • Disabling sensory disorders such as DMLA
  • Significant hearing loss
  • Subjects with risk of photosensitive epilepsy or dizziness. Subjects with Lewy body dementia

Sites / Locations

  • CHU de Nice
  • EPHAD Ancilla
  • EPHAD Clos de Cimiez
  • Hopital privé Gériatrique Les Sources

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

personalized video

generic vidéo

Arm Description

Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).

The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)

Outcomes

Primary Outcome Measures

Depression and anxiety assessment
assessment with Hamilton scale

Secondary Outcome Measures

psychotropic drugs consumption
assessment of psychotropic drugs consumption

Full Information

First Posted
June 19, 2020
Last Updated
February 10, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT04442594
Brief Title
REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders
Acronym
REMINISCENCES
Official Title
REMINISCENCES : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 2, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

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
Presentation & Pre-screening of the control group / reminiscence group Patient/resident pre-screening team meeting for the study Explanation and proposal of the study to patients and their families Signature of resident/patient and family consents Audit of inclusion and non-inclusion criteria Inclusion Medical advice for VR Clinical interview with the family or legal guardian for an accurate life history + an anamnesis interview (psychologist or doctor) with the patient or resident. Creation of video contents Creation of personalized video contents Clinical scales review Evaluation of the number of psychotropic molecules prescribed (coordinating doctor, general practitioner, geriatrician) Pre-test phase with the patient for the use of the VR headset Randomisation Session procedure As previously mentioned, the virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks. Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families). The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation. The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.) with a different virtual environment every 3 weeks. During the session, note will be taken on the subject's speech. The session will also be filmed and/or recorded with a prior signed agreement by the patient or his representative. - Last session (S6) Review of clinical scales (re-testing) Re-evaluation of drug prescriptions

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mood Disorders, Virtual Reality

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The virtual reality sessions will take place twice a week during 6 weeks. Each subject will have two different virtual environment. The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
personalized video
Arm Type
Experimental
Arm Description
Each subject of the reminiscence group will have two personalised virtual surroundings (after data being collected from team and/or families).
Arm Title
generic vidéo
Arm Type
Active Comparator
Arm Description
The subjects of the control group will be exposed to two generic virtual settings (beach, mountain etc.)
Intervention Type
Procedure
Intervention Name(s)
virtual reality session
Intervention Description
The virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks. The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation.
Primary Outcome Measure Information:
Title
Depression and anxiety assessment
Description
assessment with Hamilton scale
Time Frame
change of Hamilton score between inclusion and 6 weeks (before and after therapy)
Secondary Outcome Measure Information:
Title
psychotropic drugs consumption
Description
assessment of psychotropic drugs consumption
Time Frame
change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female aged 65 or older Accompanied in day care or in the geriatric structure of the CHU of Nice (EHPAD-USLD) Mild to moderate cognitive impairment Diagnostic criteria for Alzheimer's disease, NINCDS-ADRDA probably, Positive score on at least one of the following rating scales : NPI-ES depression/dysphoria and anxiety items + GDS 15 Patients IA caregiver = 2 on one of 2 dimensions + IA patient = 2 on one of 2 dimensions Exclusion Criteria: Diagnosed psychiatric pathology Disabling sensory disorders such as DMLA Significant hearing loss Subjects with risk of photosensitive epilepsy or dizziness. Subjects with Lewy body dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier guerin.o@chu-nice.fr, PU-PH
Organizational Affiliation
Nice University Hospital, Gerontology Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
EPHAD Ancilla
City
Nice
Country
France
Facility Name
EPHAD Clos de Cimiez
City
Nice
Country
France
Facility Name
Hopital privé Gériatrique Les Sources
City
Nice
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

REMINISCENCES and EMOTIONS : Reminiscence Triggered by Virtual Reality for Older Adults With Mood Disorders

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