Actively Recruiting

Phase Not Applicable
Age: 18Years - 50Years
All Genders
Healthy Volunteers
NCT06892340

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

Age: 18Years - 50Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Randolph AFB Physiology lab

San Antonio, Texas, United States, 78148

Actively Recruiting

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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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