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NOT YET RECRUITING
NCT06693193
NA

Personalized Virtual Environments for Managing Responsive Behaviors in Cognitively Impaired Patients: a Feasibility Study

Sponsor: Fondazione Bruno Kessler

View on ClinicalTrials.gov

Summary

The goal of this feasibility study is to explore the feasibility of using realistic, customizable virtual reality (VR) environments in response to the onset of Responsive Behaviors in elderly residents with cognitive impairment. Specifically, the study will assess; * feasibility through acceptance metrics (including recruitment rate, adherence rate, attrition rate, and tolerance to the intervention); * safety (monitoring for adverse effects related to VR headset use); * user engagement, enjoyment, and overall experience. Participants will be exposed to three VR sessions conducted before, during, or after a situation deemed activating (e.g., personal hygiene activities). Operators will conduct a baseline assessment to identify specific moments when the participant experiences responsive behaviors. Additionally, operators may administer the Oculus VR headset when responsive behaviors occur outside of baseline-identified moments.

Official title: Personalized Virtual Environments for Patients with Cognitive Impairment Exhibiting Responsive Behaviors: Proof-of-Concept and Feasibility Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-01

Completion Date

2025-09

Last Updated

2024-11-18

Healthy Volunteers

No

Interventions

DEVICE

Immersive Virtual Reality

Individuals will participate in three VR sessions using Oculus headsets, experiencing virtual environments featuring realistic natural stimuli or custom settings tailored to their preferences and valued activities. Each environment allows for the adjustment of auditory elements (such as animal sounds, rustling wind, or specific music), visual elements (such as people, objects, or animals), and the time of day and weather conditions. The operator will use a user-friendly smartphone app to customize the environment, making real-time adjustments to settings and content. Throughout the VR experience, the operator can monitor the participant's visual focus in real-time.

Locations (1)

APSP ''Grazioli''

Trento, Italy, Italy