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ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia

Primary Purpose

Dementia Alzheimers

Status
Completed
Phase
Not Applicable
Locations
Philippines
Study Type
Interventional
Intervention
virtual reality
Sponsored by
Augmented eXperience E-health Laboratory
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Dementia Alzheimers

Eligibility Criteria

40 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged 40 to 59 years old
  • Montreal Cognitive Assessment-Philippine Version (MoCA-P) score > 20
  • Neuropsychiatric Inventory (NPI) score of 0
  • Able to understand Filipino and English

Exclusion Criteria:

  • Previously diagnosed with dementia
  • Receptive aphasia
  • Previously diagnosed with a psychiatric disorder
  • Previously diagnosed with seizures or epilepsy
  • Significant visual and hearing impairment
  • Has a history of motion sickness
  • Quadriplegia or paralysis of dominant hand
  • Life expectancy of less than a year

Sites / Locations

  • College of Allied Medical Professions Clinic for Therapy Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Semi-CAVE

Head-mounted display or HMD

Arm Description

The Semi-CAVE (Figure 2) will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The user will sit in the middle of the area, giving them a viewing angle of roughly 180 degrees. The user will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar. The Semi-CAVE may be offered as a solution for rehabilitation centers.

The HMD will be a commercially available device that uses handheld controllers in addition to the head mounted apparatus, to control movement while in the VE. This device could provide a cheaper, more practical alternative to patients with mobility issues and environmental limitations brought about by the pandemic, since this can be used at home. Any patient, with supervision from their caregivers, will be able to use the applications using only the HMD system.

Outcomes

Primary Outcome Measures

The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire.
A 9-item Virtual Reality Sickness Questionnaire to assess cybersickness.
The acceptability of the design will be measured using the Place Probe.
The Place Probe is a sense of place questionnaire.
The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics.
The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction.

Secondary Outcome Measures

Full Information

First Posted
January 14, 2022
Last Updated
January 31, 2023
Sponsor
Augmented eXperience E-health Laboratory
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1. Study Identification

Unique Protocol Identification Number
NCT05265182
Brief Title
ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia
Official Title
Developing an Immersive Gamification Technology System (ImGTS) for the Management of Patients With Behavioral and Psychological Symptoms of Dementia (Phase 1 Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 28, 2022 (Actual)
Primary Completion Date
July 26, 2022 (Actual)
Study Completion Date
July 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Augmented eXperience E-health Laboratory

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 proposed research project aims to answer the question "Are immersive technology systems effective in the management and treatment of patients with BPSD?". This project is composed of three phases and the current study is the first phase. The phase 1 trial aims to create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population.
Detailed Description
The participants will undergo an intervention using the assigned ImGTS for four sessions (twice a week for two weeks), with a maximum of 45 minutes per session. VR trials are in 10- to 20-minute periods with introduction, orientation, and provisions for rest periods for patient comfort. During the experience, documentation of the patient's reaction and interaction with the ImGTS will be recorded by the researchers. The participants will be staying at the designated laboratory for not more than one hour. Demographic characteristics Demographic characteristics of the participant (age, sex, educational attainment, marital status, living conditions, hobbies and interests, previous experience with VE applications, existing illnesses, medications) will be collected by the researchers through a questionnaire. Personal data, such as name and contact information, will only be collected to allow the investigators to contact the participants, as needed. Safety Safety will be ensured by assessing a participant's experience of cybersickness. A cybersickness questionnaire, the Virtual Reality Sickness Questionnaire will be administered after each session. In this self-report questionnaire, nine symptoms will be rated as absent/none, slight, moderate, or severe. These symptoms are general discomfort, fatigue, eyestrain, difficulty focusing, headache, fullness of head, blurred vision, dizziness when the eyes are closed, and vertigo. Answering the questionnaire will take around 10 minutes. In the event that a participant will experience severe cybersickness, they may opt to discontinue the experience. They will be instructed to remove the HMD or to step out of the Semi-CAVE room to rest and recover from the symptoms. A medical professional will be present to monitor the participant's symptoms and to attend to them for further management. The reason(s) for discontinuing the experience will be documented. Acceptability The acceptability of the design will be measured using the Place Probe, a sense of place questionnaire. The questionnaire will be administered after each session, and it will collect information on a participant's experience in the VE application, particularly on (a) their general impression of the environment, (b) the key features of the environment, and (c) their feelings of presence. A positive general impression, a memorable environment, and high level of presence will indicate that the VE developed is acceptable. This will take about 10 minutes to complete. Usability Usability testing will be performed according to the PNS ISO/IEC Metrics. The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction. Additional usability metrics will be identified during the first phase of the study. The metrics will be specifically adjusted to the target participants as well as the contents to be included in the VR system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
HMD and Semi-Cave
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Semi-CAVE
Arm Type
Experimental
Arm Description
The Semi-CAVE (Figure 2) will use two screens positioned at a corner of the room, each with a ceiling-mounted short throw projector in front. The user will sit in the middle of the area, giving them a viewing angle of roughly 180 degrees. The user will interact with the system through motion sensors positioned at the corners of the area. To one side of the area will be a sufficiently powerful computer running the software. The projectors will be connected to this computer via HDMI cables or similar. The Semi-CAVE may be offered as a solution for rehabilitation centers.
Arm Title
Head-mounted display or HMD
Arm Type
Experimental
Arm Description
The HMD will be a commercially available device that uses handheld controllers in addition to the head mounted apparatus, to control movement while in the VE. This device could provide a cheaper, more practical alternative to patients with mobility issues and environmental limitations brought about by the pandemic, since this can be used at home. Any patient, with supervision from their caregivers, will be able to use the applications using only the HMD system.
Intervention Type
Procedure
Intervention Name(s)
virtual reality
Intervention Description
Create an immersive technology system for managing the behavioral and psychological symptoms of dementia and determine its acceptability, usability, and safety in the healthy adult population initially, using semi-Cave or head-mounted display.
Primary Outcome Measure Information:
Title
The incidence of cybersickness will be assessed using the Virtual Reality Sickness Questionnaire.
Description
A 9-item Virtual Reality Sickness Questionnaire to assess cybersickness.
Time Frame
Immediately after each intervention, within an hour of completion of the virtual reality game.
Title
The acceptability of the design will be measured using the Place Probe.
Description
The Place Probe is a sense of place questionnaire.
Time Frame
Immediately after each intervention, within an hour of completion of the virtual reality game.
Title
The rate of usability will be performed according to the Philippine National Standards ISO/IEC Metrics.
Description
The goal is to provide continuous improvement in the design and user experience to maximize the three components of usability: effectiveness, efficiency, and satisfaction.
Time Frame
Within an hour of the end of the study.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged 40 to 59 years old Montreal Cognitive Assessment-Philippine Version (MoCA-P) score > 20 Neuropsychiatric Inventory (NPI) score of 0 Able to understand Filipino and English Exclusion Criteria: Previously diagnosed with dementia Receptive aphasia Previously diagnosed with a psychiatric disorder Previously diagnosed with seizures or epilepsy Significant visual and hearing impairment Has a history of motion sickness Quadriplegia or paralysis of dominant hand Life expectancy of less than a year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Veeda Michelle M Anlacan, MD
Organizational Affiliation
University of the Philippines Manila
Official's Role
Principal Investigator
Facility Information:
Facility Name
College of Allied Medical Professions Clinic for Therapy Services
City
City Of Manila
State/Province
National Capital Region
ZIP/Postal Code
1000
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
No
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ImGTS for Patients With Behavioral and Psychological Symptoms of Dementia

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