Actively Recruiting
Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation
Led by 59th Medical Wing · Updated on 2025-08-15
36
Participants Needed
1
Research Sites
36 weeks
Total Duration
On this page
Sponsors
5
59th Medical Wing
Lead Sponsor
D
Defense Health Agency
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 stimulate branches of nerves on and/or around the ear, specifically the "vagus" and "trigeminal" nerves. These nerves are also responsible for your sensation of nausea and your heart rate (vagus nerve), as well as headaches (trigeminal nerve). The Sparrow System utilizes a flexible earpiece with embedded hydrogel electrodes that stick to the skin, the earpiece is disposable after use. This device is already Food and Drug Administration (FDA) approved for use in humans and is safely used for control of symptoms in a variety of other medical conditions, such as opioid withdrawal and acute stress reaction. In this study, we will determine if the Sparrow Ascent System™ impacts the development of spatial disorientation or motion sickness.
CONDITIONS
Official Title
Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy males and non-pregnant females between ages 18-50 who do not experience motion sickness symptoms
- English speaking participants
- Ability to read, understand study procedures, and provide informed consent
You will not qualify if you...
- Pregnant females
- History of cardiac problems such as congestive heart failure, heart attack, stent placement, pacemaker, or heart surgery
- Hypertension requiring daily medication
- Active vestibular diseases like Meniere's disease, migraine-associated vertigo, or labyrinthitis
- Neck pain or spinal problems
- Use of medications affecting cardiac, vestibular, or neurologic functions
- Recent illness or hospitalization within 30 days
- Pilots or individuals desensitized to motion sickness
- Use of vestibular suppressing drugs or substances within 24 hours
- History of epileptic seizures
- History of neurological diseases or traumatic brain injury
- Abnormal vital signs before the experiment (heart rate >100 or <50, systolic blood pressure >150 or <90, respiratory rate >24 or <8)
- Presence of implanted devices like pacemakers, cochlear prosthesis, or neurostimulators
- Abnormal ear anatomy or ear infection
- Other significant diseases or disorders that may increase risk or affect participation as judged by the investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Randolph AFB Physiology lab
San Antonio, Texas, United States, 78148
Actively Recruiting
Research Team
I
Isaac D Erbele, MD, ENT
CONTACT
C
Craig D Nowadly, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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