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Search / Trial NCT06892340

Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation

Launched by 59TH MEDICAL WING · Mar 21, 2025

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Motion Sickness Simulator Sickness Trigeminal Innervation Transcutaneous Auricular Neurostimulation Sparrow Ascent Neuromodulation Simulator Adaption Syndrome Transcutaneous Vagus Nerve Stimulation Auricle Mild Electrical Stimulation Cranial Nerves Occipital Nerves Cymba Concha Afferent Sensory Innervation Vagus Nerve Auriculotemporal Nerve Trigeminal Nerve Auricular Nerve Cranial Nerve V Cranial Nerve Vii Cranial Nerve Ix Cranial Nerve X Non Invasive Non Sedating

ClinConnect Summary

This clinical trial is investigating a wearable device called the Sparrow Ascent System™, designed to help reduce symptoms of motion sickness and spatial disorientation. Spatial disorientation happens when your body feels confused about where it is, which can lead to feelings of nausea, especially in situations like flying or riding in a car. The Sparrow Ascent System™ uses gentle electrical pulses to stimulate specific nerves around the ear that are linked to these feelings. This device is already approved for use in other medical conditions, and the goal of this study is to see if it can help prevent motion sickness in healthy people.

To join this trial, participants need to be healthy men or non-pregnant women aged 18 to 50 who do not currently experience motion sickness. They should also be able to speak and read English to understand the study details and provide consent. Participants will use the device and report any changes in how they feel during the study. It's important to note that individuals with certain health conditions, like heart problems or active dizziness disorders, cannot participate. This trial aims to find out if this new technology can make traveling more comfortable for those who might be prone to motion sickness.

Gender

ALL

Eligibility criteria

  • * 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

About 59th Medical Wing

The 59th Medical Wing (59 MDW) is a leading clinical trial sponsor dedicated to advancing medical care and research within the Department of Defense. Based at Joint Base San Antonio, Texas, the 59 MDW specializes in a wide range of healthcare disciplines, including aerospace medicine, surgical care, and rehabilitation. Committed to innovation and excellence, the wing conducts rigorous clinical trials to evaluate new therapies and technologies, ensuring the highest standards of patient safety and scientific integrity. Through collaboration with military and civilian partners, the 59 MDW aims to enhance the health and readiness of service members and their families while contributing to the broader medical community.

Locations

San Antonio, Texas, United States

Patients applied

0 patients applied

Trial Officials

Isaac D Erbele, MD, ENT

Principal Investigator

Brooke Army Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported