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Protocol Details

Development of Immersive VR Environments to Induce and Evaluate Cognitive Fatigability: User Experience and Healthy Control Studies

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-NR-0124

Sponsoring Institute

National Institute of Nursing Research (NINR)

Recruitment Detail

Type: No longer recruiting/follow-up only
Gender: Male & Female
Min Age: 18
Max Age: 75

Referral Letter Required

No

Population Exclusion(s)

None

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Cognitive Fatigue

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Nursing Research

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.

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Eligibility

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Patricia Brennan, Ph.D.
National Institute of Nursing Research (NINR)
National Institutes of Health
Building 38
Room 2E17B
38 Library Drive
Bethesda, Maryland 20892
(301) 496-6221
patti.brennan@nih.gov

Stephanie R. Burrison, R.N.
National Institute of Nursing Research (NINR)
National Institutes of Health
Building 10
Room 4S233
10 Center Drive
Bethesda, Maryland 20892
(202) 941-8728
stephanie.burrison@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT04883359

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