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Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation

RecruitingNAAges 18 Years - 50 YearsAll59th Medical Wing
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In plain words

What the trial is, and whether it could suit you

The purpose of this research study is to learn how a wearable nerve stimulation device, the Spark Biomedical's Sparrow Ascent System™, impacts the development of spatial disorientation and/or motion sickness in a healthy population. Spatial disorientation is when there is a "mismatch" between where a person is, and where the sense organs in their body tell them where they are. These sense organs include the inner ear (the vestibular system), the eyes (the visual system), the sense of where one's legs, back, and neck are (proprioceptive system), and one's higher thinking (cognitive centers). If spatial disorientation is severe or occurs in motion-naïve individuals, spatial disorientation can lead to motion sickness. The Sparrow Ascent System™ is a wearable, battery-operated transcutaneous auricular (ear) neurostimulation (tAN) device. This means that it uses electrical pulses to stimula

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
* Inclusion Criteria: 1. Healthy males and non-pregnant females between the ages of 18-50 who do not experience symptoms of motion sickness. 2. Participants who are English speaking. 3. Participants who are able to read and understand study procedures in order to provide informed consent. * Exclusion Criteria: 1. Females who are pregnant 2. Cardiac pathology (congestive heart failure, history of myocardial infarction, cardiac stent placement, pacemaker placement, heart surgery) 3. Hypertension requiring daily medication 4. Active vestibular disease to include Meniere's disease, migraine associated vertigo, benign paroxysmal positional vertigo, labyrinthitis 5. Neck pain or spinal pathology 6. Medications impacting cardiac, vestibular, or neurologic function 7. Recently ill or hospitalized within 30 days 8. Pilots and individuals formally desensitized to motion sickness 9. Use of vestibular suppressing medications or drugs within 24 hours of the study (antihistamines, histamine-1 receptor agonists, benzodiazepines, anticholinergics, dopamine receptor agonists, alcohol, marijuana, tobacco, opiates) 10. Participant has a history of epileptic seizures 11. Participant has a history of neurological diseases or traumatic brain injury 12. Abnormal vital signs obtained during pre-experimentation phase: * Heart Rate \>100 or \<50 * Systolic blood pressure \>150 or \<90 * Respiratory rate \>24 or \<8 13. Participant has presence of devices, e.g., pacemakers, cochlear prosthesis, neurostimulators 14. Participant has abnormal ear anatomy or ear infection present 15. Participant has any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial
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What it tests

  • Transcutaneous Auricular Neurostimulation device
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Where

1 site
Randolph AFB Physiology lab
San Antonio, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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