Clinical trial NCT05479019: Human Perception on Medical Extended Reality Devices
Official title: Human Perception on Medical Extended Reality Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Food and Drug Administration (FDA)
Sponsor class: FED
First posted: 2022-07-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Must be between 18 and 70 years old
* No gender requirement
* No sensory, proprioceptive, or neural impairments
* Ability to sit for 20-30 minutes at a time, for up to 2 hours with 5-10 minute breaks
* Adults with normal or corrected-to-normal vision that can wear an HMD comfortably.

  * For participants with corrected-to-normal vision and, in the case of an HMD that is not compatible with glasses, contact lenses will be required

Exclusion Criteria:

* History of light sensitivity, epilepsy, or seizures
* Uncorrected visual impairments
* Pregnant women
* Participants that have corrected-to-normal vision with glasses that cannot wear the HMD comfortably
* Presence of sensory, proprioceptive, neural, vestibular, or physical impairments that limit fine motor control, gross movement, normal ambulation, or ability to sit/stand as needed for the study
* Claustrophobia such that use of an HMD induces anxiety or other negative psychological response
* Cognitive impairments that limit the ability to comprehend simple written and verbal instructions or identify and locate objects in space
* Subjects with migraine headaches or that experience motion sickness
* Current or prior diagnosis of epilepsy, seizure disorder, dementia, migraines (especially with visual aura), or other neurological diseases
* Current medical condition predisposing to nausea, dizziness, or vertigo (e.g. Meniere's disease)
* Ongoing psychosis, hallucinations, or dissociative disorders affecting perception of reality
* Hypersensitivity to flashing light or motion
* Irritated skin or open wounds on the scalp and face where the AR/VR headset will rest
* Past history of use of hallucinogenic medications (e.g. LSD, mesclun, etc.)
* Prior cervical spine disorder or Brachial plexus disorder or shoulder joint disorder, or hand disorder or past surgery in any of the previous stated anatomic areas (as these might affect the use, responsiveness, and/or dexterity of upper extremities or hand-eye coordination)
* Subjects will be excluded from participation in this study if they answer yes to a screening question about taking various medications listed below: (n.b. the reasons for subject being excluded is also noted with the potential side-effects of the noted medication)

  * Antihistamines (e.g. diphenhydramine {Benadryl}, etc.) -- Drowsiness, dizziness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur.
  * Muscle relaxants (e.g. methocarbamol {Robaxin}, cyclobenzaprine {Flexeril}, carisoprodol {Soma} , etc.) -- Drowsiness, tiredness, clumsiness, headache, dizziness, lightheadedness, dry mouth, stomach upset, nausea/vomiting, or blurred vision may occur.
  * Analgesic medications (e.g. narcotics, Class II controlled substances such as propoxyphene {Darvon} , etc.) -- Low blood pressure, drowsiness, fainting, dizziness, nausea, vomiting, generalized weakness, a feeling of general discomfort called malaise.
  * Sleep medications (e.g. zolpridem {Ambien}, etc.) -- Daytime drowsiness, dizziness, weakness, feeling "drugged" or light-headed; tired feeling, loss of coordination; memory loss, stuffy nose, dry mouth, nose or throat irritation; nausea, constipation, diarrhea, upset stomach, headache, muscle pain, anxiety, depression, aggression, agitation, confusion, or hallucinations (hearing or seeing.) This is not a complete list of side effects and others may occur.

Primary outcomes:
measure: Display Human Perception Assessment
timeFrame: 2 years initially
Secondary outcomes:
Other outcomes:
Locations:
city: Silver Spring
country: United States
facility: 10903 New Hampshire Ave, WO62
state: Maryland
Study officials:
References: