Study Design Support
Basic Study Information
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Official Title
- Cybersickness Prevention and Mitigation in Virtual Reality for Healthy Volunteers
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Brief Summary
- Background: People use virtual reality (VR) technology to play games, socialize, work, or receive medical care. Some people have "cybersickness" after using VR. Cybersickness is similar to motion sickness. Symptoms include eye strain, nausea, dizziness, or headache. The symptoms are usually mild and go away after the person stops using VR. New software called Motion Reset is being designed to reduce symptoms of cybersickness during VR use. Objective: To see if Motion Reset software can reduce cybersickness in people using VR. Eligibility: Healthy adults aged 18 to 60 years. Design: Participants will have 1 clinic visit that will last about 1 hour. They will answer questions about how they are feeling. They will learn how to use the VR headset and the handheld game controllers. The study will be broken into 2 parts. For the first part, participants will be assigned to 1 of 3 groups: Group 1 will participate in a VR experience designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller. Group 2 will participate in a VR experience that is not designed to prevent cybersickness. They will view screens and move around while they press buttons on a controller. Group 3 will have no VR experience. Participants will complete 2 questionnaires about their experiences in the first part of the study. For the second part, all participants will spend up to 20 minutes playing a commercial VR game called Jurassic World Aftermath. Every few minutes, they will be asked if they are experiencing discomfort. After playing the game, participants will complete 12 questionnaires about their experience....
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Sponsor
- National Human Genome Research Institute (NHGRI)
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Recruitment Status
- NOT_YET_RECRUITING
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Study Objective
- PREVENTION
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ClinicalTrials.gov ID
- NCT06552754
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Additional Identification number
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Last Update Posted
- 2025-06-11
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Study Completion (Actual)
- 2026-05-01
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Study Record Versions
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Contacts and Locations
- facility: Iowa State University
city: Ames
state: Iowa
zip: 50011
country: United States
geoPoint: {lat=42.03471, lon=-93.61994}
facility: National Institutes of Health Clinical Center
city: Bethesda
state: Maryland
zip: 20892
country: United States
contacts: [{name=NIH Clinical Center Office of Patient Recruitment (OPR), role=CONTACT, phone=800-411-1222, phoneExt=TTY dial 711, email=ccopr@nih.gov}]
geoPoint: {lat=38.98067, lon=-77.10026}
Target Disease and Treatment Information
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Conditions
- Healthy Volunteers
Virtual Reality
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TargetDisease
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ProductName
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IsActiveControl
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IsControlDrug
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IsPlacebo
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ControlDrug
- -
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Intervention / Treatment
- type: BEHAVIORAL
name: Motion Reset
description: virtual reality-based experiential, sensory intervention
armGroupLabels: [Intervention: Motion Reset]
type: BEHAVIORAL
name: Placebo
description: virtual reality-based experiential, sensory experience without intervention
armGroupLabels: [Placebo experience]
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Intervention
Study Design and Implementation Information
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Study Type
- INTERVENTIONAL
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Phase
- NA
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Allocation
- RANDOMIZED
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Interventional Model
- PARALLEL
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Subject Blind
- PARTICIPANT
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Arm Label
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Arm Type
- label: Intervention: Motion Reset
type: EXPERIMENTAL
description: Participate in virtual reality activities
interventionNames: [Behavioral: Motion Reset]
label: No intervention
type: NO_INTERVENTION
label: Placebo experience
type: PLACEBO_COMPARATOR
description: Participate in virtual reality activities
interventionNames: [Behavioral: Placebo]
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NumberOfInterventionGroups
- 0
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GroupEnrollment
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Target Number of Participant
- 0
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InstitutionLocation
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InstitutionPhoneNumber
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Study Site
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Location Countries
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Countries of recruitment
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Study Start (Actual)
- 2025-06-16
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Arm Description
Subject Information and Eligibility Criteria
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Inclusion and Exclusion Criteria
- * INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Stated willingness to comply with all study procedures and availability for the duration of the study * Aged 18-60 * Ability to read, speak, and write in English * Normal or corrected-to-normal hearing * Normal vision or corrected-to-normal without use of glasses. Contact lenses for corrective purposes are acceptable. Ability to read, speak and write in English is a requirement because the VR-based study materials and assessment are only available in English and several of the key questionnaires for the study are not validated in other languages. EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: * Reporting motion sickness propensity of 0 or 10 on a 0-10 scale where 0 =never experience motion sickness and 10 = experience motion sickness very frequently (self-assessed by participants). * Reporting a history of photo-sensitive seizure disorders, vestibular disorders and/or other conditions that may make participants prone to nausea, dizziness, vertigo, ataxia, or incoordination. * Known pregnancy * Reporting current use of medication or supplements that inhibit nausea, e.g., Zofran/ondansetron, Phenergan/promethazine
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minimum age
- 18 Years
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maximum age
- 60 Years
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Standard ages
- ADULT
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Sexes Eligible for Study
- ALL
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Accepts Healthy Volunteers
- NO
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Enrollment (Actual)
- 150
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Original Enrollment (Actual)
- 0
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Final Enrollment Number
- 0
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FinalSubjectSelectionDate
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AnalysisTargetGroup
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DemographicInformation
Assessment and Outcome
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Primary Outcome Measures
- measure: self-reported cybersickness
description: Assessed on numerical scale
timeFrame: during and after VR use
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Secondary Outcome Measures
- measure: discontinuation of VR use
description: decision to discontinue VR during active session
timeFrame: during VR use
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PrimaryEndpointResult
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Primary Completion Date (Actual)
- 2026-05-01
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ClinicalTrialResultSummary
Contact Information and Person in Charge
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Telephone
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Address
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Name
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Title
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Telephone
- name: Susan J Persky, Ph.D.
role: CONTACT
phone: (301) 451-1268
email: NihVRStudy@nih.gov
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Affiliation