Recruiting

Motion Sickness Device

Sponsor:

59th Medical Wing

Code:

NCT06892340

Conditions

Motion Sickness

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Transcutaneous Auricular Neurostimulation device

Study Details

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.

Conditions

Motion Sickness

Study ID

NCT06892340

Start date

Feb 21, 2025

Status verified date

Aug, 2025

Completion date

Oct 31, 2025

Anticipated

Primary completion date

Oct 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

  • 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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

no intervention: Sham Transcutaneous Auricular Neurostimulation Device (Group 2)

The Sparrow Ascent Clinical Tool will be used to designate the tAN device as either active or sham. For participants randomized to the sham tAN group (Group 2), the Sparrow Ascent device will be programmed to sham settings. The participant receives a device that is turned on at the time of earpiece placement but does not provide electric stimulation. The subjects will remain blinded to their group assignment. At each interaction with the subject, the research coordinator will inform the subject that the device may be activated, and they may or may not feel stimulation at the time of activation.

Subjects will then undergo spatial disorientation and motion sickness challenges. Vital signs will be obtained at specific time markers, and questionnaires and assessments completed.

active comparator: Active Transcutaneous Auricular Neurostimulator Device (Group 1)

The Sparrow Ascent Clinical Tool will be used to designate the tAN device as either active or sham. For participants randomized to the active tAN group (Group 1), the Sparrow Ascent device will be programmed to the preset stimulation parameters. If the participant states that the stimulation intensity is discomforting, the research coordinator will gradually decrease/increase until a comfortable stimulation intensity is achieved. After the device is programmed, participants' stimulation amplitude (in mA) will be documented.

The subjects will remain blinded to their group assignment. At each interaction with the subject, the research coordinator will inform the subject that the device may be activated, and they may or may not feel stimulation at the time of activation.

Subjects will then undergo spatial disorientation and motion sickness challenges. Vital signs will be obtained at specific time markers, and questionnaires and assessments completed.

Interventions

Transcutaneous Auricular Neurostimulation device

The Sparrow Ascent device will be programmed to the preset stimulation parameters. Two individual stimulation frequencies will be set: 15 Hz at cymba concha (Region 1/Channel 1; vagal innervation) and 100 Hz adjacently anterior to the tragus (Region 2/Channel 2; trigeminal innervation). The pulse duration will be set to 250 #s for all participants. The stimulation intensities (mA) will be set to 1.0 and 1.4 (for Region 1 and 2, respectively) based on the median values observed in the previous data set. If the participant states that the stimulation intensity is discomforting, the research coordinator will gradually decrease/increase until a comfortable stimulation intensity is achieved

Primary outcome measure

  • Graybiel Scale [ Time Frame: Baseline, and at 5- and 10-minutes post motion sickness and at 5- and 10-minutes post spatial disorientation challenges. ]

Central Contacts and Locations

Central contacts

Isaac D Erbele, MD, ENT

210-916-2985isaac.d.erbele.mil@health.mil

Craig D Nowadly, MD

757-784-1175craig.d.nowadly.mil@health.mil

Locations

Randolph AFB Physiology lab

Recruiting

San Antonio, Texas, United States, 78148

More Information

Sponsor

59th Medical Wing

Last update posted

Aug 15, 2025

Last verified

Aug, 2025

Keywords

  • Motion Sickness
  • Simulator Sickness
  • Trigeminal innervation
  • Transcutaneous auricular neurostimulation
  • Sparrow Ascent
  • Neuromodulation
  • Simulator adaption syndrome
  • Transcutaneous vagus nerve stimulation
  • Auricle
  • Mild electrical stimulation
  • Cranial nerves
  • Occipital nerves
  • Cymba Concha
  • Afferent sensory innervation
  • Vagus Nerve
  • Auriculotemporal nerve
  • Trigeminal nerve
  • Auricular nerve
  • Cranial nerve V
  • Cranial nerve VII
  • Cranial nerve IX
  • Cranial nerve X
  • Non-invasive
  • Non-sedating

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by 59th Medical Wing on 2025-08-15.