Wearable device to reduce motion sickness and spatial disorientation
A Non-Invasive, Non-Sedating Device to Mitigate Motion Sickness and Spatial Disorientation
This study tests if a new wearable device can help healthy people feel less motion sickness and disorientation when exposed to things like flight simulations and spinning chairs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | 59th Medical Wing Federal |
| Locations | 1 site (San Antonio, Texas) |
| Trial ID | NCT06892340 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy males and non-pregnant females aged 18-50 who do not experience motion sickness.
Not a fit: Patients with existing vestibular disorders, cardiac issues, or those on medications affecting vestibular function may not benefit from this study.
Why it matters
Potential benefit: If successful, this device could provide a non-invasive solution for preventing motion sickness and improving spatial orientation.
How similar studies have performed: While the approach of using transcutaneous auricular neurostimulation is relatively novel, similar studies have shown promise in managing motion sickness.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Antonio, Texas
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.