Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation
This study tests a wearable nerve stimulation device called the Sparrow Ascent System to see if it can help prevent motion sickness and spatial disorientation (dizziness from confusion about body position). Researchers will evaluate how the device works in healthy volunteers to understand its potential benefits.
Key Objective: The trial is testing whether a wearable nerve stimulation device can reduce or prevent motion sickness and spatial disorientation.
Who to Consider: Healthy adults interested in helping advance motion sickness prevention research should consider enrolling.
Trial Parameters
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 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.
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 recept