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

NCT06693193 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2024-11-18

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • Fondazione Bruno Kessler

    lead OTHER

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2025-07-31
Completion
2025-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06693193 on ClinicalTrials.gov