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

Alzheimer Disease Clinical Trial

— REMINISCENCES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04442594
• Other study ID #: 20-PP-11
• Status: Completed
• Phase: N/A
• Start date: December 2, 2020
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 1, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Mood Disorders
• Virtual Reality

Intervention

Procedure:
• virtual reality session
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.

Locations

Country	Name	City	State
France	CHU de Nice	Nice
France	EPHAD Ancilla	Nice
France	EPHAD Clos de Cimiez	Nice
France	Hopital privé Gériatrique Les Sources	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression and anxiety assessment	assessment with Hamilton scale	change of Hamilton score between inclusion and 6 weeks (before and after therapy)
Secondary	psychotropic drugs consumption	assessment of psychotropic drugs consumption	change in psychotropic drugs consumption between inclusion and 6 weeks (before and after therapy)