Wearable device to reduce motion sickness and spatial disorientation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research evaluates the effectiveness of the Sparrow Ascent System™, a wearable nerve stimulation device, in reducing motion sickness and spatial disorientation in healthy individuals. Participants will be randomly assigned to either an active device group or a sham device group while undergoing various stimuli, such as an electronic flight simulator and a rotating chair. The study aims to monitor vital signs and assess the participants' responses to these stimuli to determine the device's impact on symptoms of motion sickness.

Why it matters

Who can join: the full rules

* 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

Where it's running

• Randolph AFB Physiology lab
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Isaac D Erbele, MD, ENT — Brooke Army Medical Center
• Study coordinator: Isaac D Erbele, MD, ENT
• Email: isaac.d.erbele.mil@health.mil
• Phone: 210-916-2985

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.