Immersive VR Environments to Induce and Evaluate Cognitive Fatigability

NCT04883359 | Terminated

• 2 other identifiers: 10001744001744-NR
• Study Type: observational
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cognitive Fatigue

Keywords

Emotional Regulation; Cognitive Interference; Planning; Behavioral Regulation; Stress Impact on Cognition; Natural History

Outcome Measures

Primary Outcomes (2)

• Phase 1: The total tally of the number of times a 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.

  Phase 1: The outcome is the effectiveness of the grocery shopping training experience as indicated by the ability of healthy adults to perform all required shopping tasks in the immersive virtual reality environment.

  During study

• Phase 2: The level of fatigue experienced after participating in a VR experience as measured by the Visual Analog Scale- Fatigue (VAS-F).

  Phase 2: Self-reported change in cognitive fatigue.

  During study

Secondary Outcomes (2)

• Obtain initial data pertaining to the environment's ability to create feelings of fatigue as intended.

  During study

• Identify performance and potential eye tracking measures that objectively identify fatigability.

  During study

Study Arms (1)

Healthy Volunteers

From the Washington, D.C. metropolitan area

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers from the Washington D.C. metropolitan area

You may qualify if:

• Male or female participant aged 18-75
• Willingness to complete study procedures
• Willing to provide feedback about VR experiences
• Able to provide his/her own consent

You may not qualify if:

• Not fluent in English
• Any impairment in visual functioning (e.g., 3-d depth perception, visual acuity, oculomotor control) not corrected with lenses
• Eye pain or iritis
• Susceptibility to photogenic seizures and/or diagnosis of seizure disorder
• Inability to use hands to manipulate objects
• Diagnosis of a neurological condition
• Diagnosis of a sleep disorder
• Current treatment for chronic physical pain, migraines, any diagnosis of a clinical condition associated with cognitive or physical fatigue (e.g. multiple sclerosis, chronic fatigue syndrome, etc.)
• Any history of acquired brain injury
• Current cold/flu symptoms
• NINR employee/staff or subordinate, relative, and/or co-worker of NINR employee/staff or a study investigator.
• For phase 2, participation in phase 1

Sponsors & Collaborators

• National Institute of Nursing Research (NINR): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Holdnack JA, Brennan PF. Usability and Effectiveness of Immersive Virtual Grocery Shopping for Assessing Cognitive Fatigue in Healthy Controls: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Aug 4;10(8):e28073. doi: 10.2196/28073.

  PMID: 34346898 DERIVED

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-Control; Social Behavior; Behavior

Study Officials

• Patricia Brennan, Ph.D.

  National Institute of Nursing Research (NINR)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 12, 2021
• Study Start: June 16, 2021
• Primary Completion: October 3, 2023
• Study Completion: October 3, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

US (1)