NCT05479019

Human Perception on Medical Extended Reality Devices

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Food and Drug Administration (FDA) · Federal
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The proposed research will collect participant's responses that respond to questions about visibility of certain signals on an immersive mixed reality environment. These responses will be used to assess Head Mounted Display (HMD) quality and task performance. Other collected data may be included such as response time and eye movements. Responses will be collected via an FDA application designed to work with a wide range of HMDs and able to display both 2D simple scenes and 3D complete scenes. This application allows a human observer to look at a signal (sinusoidal, disk, sphere, etc.) on a synthetic noisy background or a realistic 3D scene both in virtual reality and augmented reality immersive environments. The application will also provide instructions and a response interface for the observer to respond to questions related to the visibility and to gather task performance measurements. Participants will not be asked to complete tasks that require specific training or skills. Any adult human with normal or corrected-to-normal vision that can wear an HMD is eligible to participate in this experiment. Data collected will not include identifiable information. FDA will perform participant enrollment and data collection, ensuring management of PII in accordance with federal rule. Participants will be recruited at will and in person, using promotional materials only containing language within this document. Participants will sign the attached consent form either electronically or by hard copy.

Conditions

• Healthy

Interventions

Type	Name	Description
BEHAVIORAL	Visual stimuli	Stimuli will be shown to participants and they will be asked to perform a visual task.

Timeline

• Start date: 2022-07-01
• Primary completion: 2023-06-01
• Completion: 2023-06-01
• First posted: 2022-07-28
• Last updated: 2023-07-13

Locations

1 site across 1 country: United States