Status:
RECRUITING
Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation
Lead Sponsor:
59th Medical Wing
Collaborating Sponsors:
Defense Health Agency
Conditions:
Motion Sickness
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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 s...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- Healthy males and non-pregnant females between the ages of 18-50 who do not experience symptoms of motion sickness.
- Participants who are English speaking.
- Participants who are able to read and understand study procedures in order to provide informed consent.
Exclusion
- Females who are pregnant
- Cardiac pathology (congestive heart failure, history of myocardial infarction, cardiac stent placement, pacemaker placement, heart surgery)
- Hypertension requiring daily medication
- Active vestibular disease to include Meniere's disease, migraine associated vertigo, benign paroxysmal positional vertigo, labyrinthitis
- Neck pain or spinal pathology
- Medications impacting cardiac, vestibular, or neurologic function
- Recently ill or hospitalized within 30 days
- Pilots and individuals formally desensitized to motion sickness
- 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)
- Participant has a history of epileptic seizures
- Participant has a history of neurological diseases or traumatic brain injury
- 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
Key Trial Info
Start Date :
February 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT06892340
Start Date
February 21 2025
End Date
October 31 2025
Last Update
August 15 2025
Active Locations (1)
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1
Randolph AFB Physiology lab
San Antonio, Texas, United States, 78148