Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT04883359 |
| Other study ID # |
10001744 |
| Secondary ID |
001744-NR |
| Status |
Terminated |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 16, 2021 |
| Est. completion date |
October 3, 2023 |
Study information
| Verified date |
October 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Background:
Immersive virtual reality (VR) technology is used by researchers to measure how people
respond to complex stimuli in a controlled environment. Cognitive fatigue (CF) can result in
serious consequences such as mistakes and accidents. Researchers want to see if VR can be
used to learn more about CF.
Objective:
To test the user experience of a VR program designed to study individual differences in the
susceptibility to develop CF in healthy people while performing activities of daily living.
Eligibility:
Healthy adults ages 18-75 from the Washington Metropolitan area
Design:
Participants will be screened with questions about their health and medical history.
The VR program simulates a real-world grocery shopping environment. Participants will be
given a shopping task.
Participants will be seated. They will wear a head-mounted display (HMD) for 1.5 hours. The
device is worn on the head. It presents images to the eyes. Eye-tracking data may be
collected through the HMD.
The following will happen in the VR environment:
- Participants will be seated at a kitchen table. They will complete a pillbox task 2
times.
- Participants will be placed in a small grocery store. They will be trained how to use
the controllers to shop.
- Participants will appear to be seated in front of a screen. They will be shown how to
answer questions about how tired they feel and if the tasks are hard to do.
- Participants will be placed in a large grocery store. They will complete a shopping
task.
Participants will complete surveys. They will also answer questions about the VR experience.
Participants will have 1 or 2 study visits. It will last 3-4 hours total.
Description:
Objective: This study evaluates the utility of immersive virtual environments for objectively
studying individual differences in the susceptibility to develop cognitive fatigue in healthy
controls while performing instrumental activities of daily living (IADL) in two phases. Phase
1 aims to test functionality and user experience of the virtual reality (VR) experience; and
phase 2 aims to evaluate the level of fatigue experienced after participating in a VR
experience as measured by the Visual Analog Scale-Fatigue (VAS-F). The primary goal of the
protocol is the study of individual differences in subjective fatigability associated with
grocery shopping using immersive Virtual Reality as a research platform. The secondary
objective of the protocol is to identify objective measures of cognitive fatigue.
Primary Endpoint Phase 1: The phase 1 primary dependent measure is the total count of the
number of times, after completing the grocery shopping training exercise, the subject
required research staff to explain how to use the controller, how to move or inspect objects,
and/or how to move from one location to another location in the grocery store environment.
Secondary Endpoint for Phase 1: the ocular and general symptoms score from the virtual
reality symptom questionnaire (Ames et al., 2005); and the total score from the presence
questionnaire (Regenbrecht et al., 2002).
The Primary Endpoint for Phase 2 primary:Total score of VAS-F (Lee et al., 1991).
The Secondary Endpoint for Phase 2;Self-reported cognitive load score measured by the
NASA-TLX (Hart et al., 1988), eye-tracking data (e.g., percent eye-closure, fixation length,
blink rate) and task performance measures (e.g. shopping list total correct item selection
score, shopping list total incorrect item selection score, average item-selection time
score).
Study Population: The study plans to enroll a total of 84 (24 in phase 1 and 60 in phase 2)
healthy participants from the Washington Metropolitan area between ages 18-75.
Key Inclusion/Exclusion Criteria: Both study phases utilize the same key inclusion/exclusion.
Participants must be between the ages (Bullet) 18 and 75 years. Key exclusion criteria
include: visual impairment in the form of limited or reduced 3D vision, oculomotor
disorder/dysfunction, susceptibility to visually-induced seizures, iritis, frequent
headaches/migraines, severe sensitivity to motion sickness and any impairment in the use of
arms/hands/fingers.
Design: All participants will complete the study at the NIH main campus clinical center. This
is a two-phase research study. All participants will be screened for physical health,
cognitive and visual symptoms via self-report. Phase 1 combines a traditional user experience
design that utilizes qualitative, quantitative, and observational methods to test the
software functionality, user interface, and realism of the immersive experience and a
randomized control trial to estimate of effectiveness of the fatigue induction tasks. Phase 2
utilizes a 3-arm randomized control trial, where participants will be randomized into one of
three virtual shopping experiences, a control condition (exploration of the shopping
environment), a cognitively challenging condition (standard shopping list completion task),
or a cognitive and emotionally challenging condition (shopping list with interruptions,
interference, and rework). All participants will complete questionnaires and cognitive tests
pre-and-post VR environment. Questionnaires related to target processes (fatigue and
workload) are administered in the environment. After completing post-environment
questionnaires, the participants are provided an opportunity to give verbal feedback about
the experience and to note any observed problems with the interface or use of controllers, as
well as their VR experience.
Study Duration: Phase 1 is expected to be completed in a period of 8 months from opening of
enrollment to completion of data analysis. Phase 2 will require 12 months from opening of
enrolment until data analysis.
Participant Duration: Phase 1 is completed in one visit to the NIH campus, Phase 2 may be
completed in 1 or 2 visits to the NIH campus within the same week or consecutive weeks.
