Motion SicknessNCT06892340
Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation
A study testing Transcutaneous Auricular Neurostimulation device in people with Motion Sickness, run by 59th Medical Wing at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Motion Sickness
- What is being tested?
- Transcutaneous Auricular Neurostimulation device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2025to 31 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Randolph AFB Physiology lab
San Antonio, Texas, 78148
About this study
Official title: A Non-Invasive, Non-Sedating Device to Mitigate Motion Sickness and Spatial Disorientation
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.
Read the 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 sickness in a healthy population. Study participants will be given monitoring equipment to wear during the study, which will record the participant's vital signs throughout the experiment.
Participants will be randomly assigned to one of two groups. Randomization is a process like flipping a coin and meaning there is a chance of being assigned to either of the groups. The two groups include one group where the Sparrow Ascent System™ is turned on. The second group will be given a "sham" Sparrow Ascent System™. A sham device is an inactive Spark Sparrow Therapy System™ that looks like the normal device, but that does not provide any therapy.
Participants will be given different stimuli that may cause spatial disorientation and motion sickness. This will include an electronic flight simulator and a rotating chair. In the flight simulator, participants will be given different tasks to complete that often cause some minor spatial disorientation. In the rotating chair, investigators will spin participants around at a steady rate for 10 minutes and ask the participants to change the participants head position in ways that often cause motion sickness. Before, during, and after these stimuli participants will be asked to complete a series of tests to determine if the participants are becoming susceptible to either spatial disorientation or motion sickness. These tests will include asking how the participants are feeling throughout the stimuli, written questionnaires about how the participants feel. Before and after stimuli, participants will also be asked to perform simple tasks to test the participants orientation and performance including hand-eye-coordination, object tracking, and reaction time.
- Conditions
- Motion Sickness
- Being tested
- Transcutaneous Auricular Neurostimulation device
- 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
- Medical subject headings
- Motion Sickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Neurostimulation deviceDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Sham Transcutaneous Auricular Neurostimulation Device (Group 2) | No intervention | 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 Transcutaneous Auricular Neurostimulator Device (Group 1) | Active comparator | 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. Receives: Device: Transcutaneous Auricular Neurostimulation device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graybiel Scale
The Graybiel scale is a commonly used scale for identifying and rating motion sickness symptoms. It was designed to survey multiple dimensions of motion sickness characterized by the degree of 6 representative cardinal symptoms: Nausea and vomiting, skin color, cold sweating, increased salivation, drowsiness, pain and central nervous system symptoms. Each cardinal symptom category is rated by the participant and a corresponding score is calculated. Lesser symptoms are scored with lower point values, 1, 2 or 4 points depending on the severity of that particular symptom with higher scores indicating increased severity. More severe symptoms are scored 8 or 16 points. Values greater than or equal to 16 total points is categorized as frank sickness, 8 to 15 points is severe malaise, 5 to 7 points is moderate malaise A, 3 to 4 points is moderate malaise B, and 1 to 2 points is categorized as slight malaise.
Measured: Baseline, and at 5- and 10-minutes post motion sickness and at 5- and 10-minutes post spatial disorientation challenges.
Secondary outcomes (8)
Vitals: Blood pressure
The force of blood pushing against the walls of arteries. Two pressures are measured in mm Hg and are captured via a blood pressure cuff. The systolic pressure in the arteries when the heart contracts and the diastolic pressure in the arteries when the heart relaxes. This is shown numerically with the systolic pressure over the diastolic pressure.
Measured: Baseline and immediately post spatial disorientation challenge and immediately post motion sickness challenge. At 90 minutes post motion sickness challenge.
Misery Scale (MISC)
Misery Scale (MISC); an 11-point rating scale used to measure the severity of motion sickness symptoms, ranging from no symptoms at all (0) to severe nausea and vomiting (10), with intermediate levels representing increasing discomfort. It measures how "miserable" one feels due to motion sickness. It provides a detailed progression of symptoms to better understand the severity of motion sickness.
Measured: Baseline, and at 3 times during the spatial disorientation challenge, at 5- and 10-minutes post spatial disorientation challenge as well as 1-minute intervals during the motion sickness challenge and 5- and 10-minutes post motion sickness challenge.
Motion Sickness Assessment Questionnaire (MSAQ)
Motion Sickness Assessment Questionnaire (MSAQ). An instrument that helps assess the experience of motion sickness on a multi-dimensional level. The MSAQ measures four dimensions of motion sickness, gastrointestinal, central, peripheral, and sopite-related (drowsiness, yawning, disengagement). Motion sickness can be a complex set of interacting psychophysiological symptoms that are hard to define. Moreover, one person may experience one symptom to a greater degree than another person, yet both would be experiencing "motion sickness". Additionally, an individual may experience a different feeling of motion sickness depending on the context of what is causing the motion sickness, (boat vs. vehicle vs. visual stimulus) with each potentially eliciting different symptoms. Participants are asked to assess their motion sickness experience by rating 16 statements (ex. I felt sick to my stomach, I felt faint like) from 1-9 with increasing numbers indicating increased severity.
Measured: Baseline, and 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.
Simulator sickness questionnaire (SSQ)
The Simulator Sickness Questionnaire (SSQ), a tool that helps assess the effects of the environment on an individual's health. A set of sixteen symptoms qualified under nausea, oculomotor discomfort, and disorientation categories are rated from one to four from (1 none, 2 slight, 3 moderate, 4 severe). These symptoms include general discomfort, fatigue, headache, eye strain, difficulty focusing, increased salivation, sweating, nausea, difficulty concentrating, fullness of head, blurred vision, dizzy (eyes open), dizzy (eyes closed), vertigo, stomach awareness and burping. Via calculations the answer to each symptom specific severity question results in three representative sub scores, Nausea related, Oculomotor related, and Disorientation related. These are then combined to get an overall simulator sickness severity score. The SSQ was developed in response to motion sickness questionnaires being deficient or irrelevant in measuring simulator sickness.
Measured: Baseline and at 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.
Motion sickness susceptibility questionnaire
The Motion sickness Susceptibility Questionnaire predicts individual differences in motion sickness based on stimuli. This questionnaire considers motion type (cars, fair rides, trains, planes etc.), sickness severity ratings, childhood versus adult experiences to find out how susceptible an individual may be to motion sickness and what sorts of motion are the most effective in causing sickness. The participant is asked to rate each motion type as never felt sick, rarely felt sick, sometimes felt sick, frequently felt sick or not applicable if they never traveled via that particular motion type. They are asked the same questions for "As a child" and "Over the last 10 years".
Measured: Baseline
Functional Ability Assessment
The Senaptec Sensory Station is a state-of-art sensory evaluation \& training station which assesses 10 visual and sensorimotor skills including visual clarity, contrast sensitivity, depth perception, near-far quickness, perception span, multiple object tracking, reaction time, target capture, eye-hand coordination and go / no go. This assessment will give the study team a baseline reference for the subject's functional ability which will then be compared/contrasted to the same assessment given post each spatial disorientation and motion sickness challenge.
Measured: Baseline and 15 minutes post spatial disorientation challenge and 15 minutes post motion sickness challenge.
Vitals: Heart rate
The number of times a person's heart beats in one minute. Source: Polar H10 Heart Rate Sensor.
Measured: Continuously throughout the study day, starting at baseline and stopping 90 minutes post motion sickness challenge.
Vitals: Heart Rate Variability
Heart rate variability is the variation in time between heart beats. It is a measure of how well your body can handle stress and recover from physical activity. Source: Polar H10 Heart Rate Sensor.
Measured: Continuously throughout the study day, starting at baseline and stopping 90 minutes post motion sickness challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start21 Feb 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Motion SicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a prospective, randomized, double-blinded, sham-controlled investigation of the effects of transcutaneous auricular neurostimulation (tAN) on spatial disorientation and motion sickness. Participants will be recruited from a motion-naïve population and randomized into two groups: Group 1 (n = 18): Active tAN initiated 45-minutes before simulated disorientation Group 2 (n = 18): Passive Sham tAN Experimentation will take place in 5 stages: (Pre-experimentation) 1\) prior to spatial disorientation challenge, 2) spatial disorientation challenge, 3) between challenges, 4) motion sickness challenge, 5) conclusion At the conclusion of pre-experimentation, the subjects will be placed with a tAN earpiece on their left ear. A tAN device will be programmed based on the participant study group and will be connected to the participant's earpiece.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 59th Medical Wing
- Sponsor type
- US federal agency
- Collaborators
- Defense Health Agency
- Responsible party
- Sponsor
- Investigators
- Isaac D Erbele, MD, ENT, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892340
- Sponsor's protocol ID
- C.2024.076 FWH20240041H
- Other IDs
- ST 1186
- Status last verified
- Aug 2025
- First submitted
- 17 Jan 2025
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Publications
Heinle, Todd E. and William R. Ercoline. "Spatial Disorientation: Causes, Consequences and Countermeasures for the USAF." (2003).
Mark S. George, Ziad Nahas, Daryl E. Bohning, Qiwen Mu, F. Andrew Kozel, Jeffrey Borckhardt, Stewart Denslow, Mechanisms of action of vagus nerve stimulation (VNS), Clinical Neuroscience Research, Volume 4, Issues 1-2, 2004, Pages 71-79, ISSN 1566-2772, https://doi.org/10.1016/j.cnr.2004.06.006.
Ebenholtz SM, Cohen MM, Linder BJ; New Collective Author. The possible role of nystagmus in motion sickness: a hypothesis. Aviat Space Environ Med. 1994 Nov;65(11):1032-5.
PubMed 7840743Rogers D, Van Syoc D. Clinical Practice Guideline for Motion Sickness. November 2011. http://www.asams. org/guidelines/Completed/NEW%20Motion%20Sickness.htm. Accessed January 11, 2022.
Kramer MR, Wasserman EB, Teel EF, et al Effect of protective helmets on vision and sensory performance. British Journal of Sports Medicine 2017;51:A65.
Caserman, P., Garcia-Agundez, A., Gámez Zerban, A. et al. Cybersickness in current-generation virtual reality head-mounted displays: systematic review and outlook. Virtual Reality 25, 1153-1170 (2021). https://doi.org/10.1007/s10055-021-00513-6
Chan G, Moochhala SM, Zhao B, Wl Y, Wong J. A comparison of motion sickness prevalence between seafarers and non-seafarers onboard naval platforms. Int Marit Health. 2006;57(1-4):56-65.
PubMed 17312694Antunano MJ, Hernandez JM. Incidence of airsickness among military parachutists. Aviat Space Environ Med. 1989 Aug;60(8):792-7.
PubMed 2775137Jenkins DD, Khodaparast N, O'Leary GH, Washburn SN, Covalin A, Badran BW. Transcutaneous Auricular Neurostimulation (tAN): A Novel Adjuvant Treatment in Neonatal Opioid Withdrawal Syndrome. Front Hum Neurosci. 2021 Mar 8;15:648556. doi: 10.3389/fnhum.2021.648556. eCollection 2021.
PubMed 33762918Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186/s42234-022-00095-x.
PubMed 35978394Cowings PS, Toscano WB, DeRoshia C, Tauso R; New Collective Author. Effects of Command and Control Vehicle (C2V) operational environment on soldier health and performance. Hum Perf Extrem Environ. 2001 Jun;5(2):66-91.
PubMed 14649629Molefi E, McLoughlin I, Palaniappan R. On the potential of transauricular electrical stimulation to reduce visually induced motion sickness. Sci Rep. 2023 Feb 25;13(1):3272. doi: 10.1038/s41598-023-29765-9.
PubMed 36841838Bauer S, Baier H, Baumgartner C, Bohlmann K, Fauser S, Graf W, Hillenbrand B, Hirsch M, Last C, Lerche H, Mayer T, Schulze-Bonhage A, Steinhoff BJ, Weber Y, Hartlep A, Rosenow F, Hamer HM. Transcutaneous Vagus Nerve Stimulation (tVNS) for Treatment of Drug-Resistant Epilepsy: A Randomized, Double-Blind Clinical Trial (cMPsE02). Brain Stimul. 2016 May-Jun;9(3):356-363. doi: 10.1016/j.brs.2015.11.003. Epub 2016 Jan 20.
PubMed 27033012McIntire LK, McKinley RA, Goodyear C, McIntire JP, Brown RD. Cervical transcutaneous vagal nerve stimulation (ctVNS) improves human cognitive performance under sleep deprivation stress. Commun Biol. 2021 Jun 10;4(1):634. doi: 10.1038/s42003-021-02145-7.
PubMed 34112935Yakunina N, Kim SS, Nam EC. Optimization of Transcutaneous Vagus Nerve Stimulation Using Functional MRI. Neuromodulation. 2017 Apr;20(3):290-300. doi: 10.1111/ner.12541. Epub 2016 Nov 29.
PubMed 27898202
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Invasive, Non-Sedating Device to Mitigate Motion Sickness and Spatial Disorientation
- ClinicalTrials.gov ID
- NCT06892340
- Acronym / sponsor ID
- C.2024.076 FWH20240041H
- Conditions
- Motion Sickness
- Keywords
- Motion Sickness, Simulator Sickness, Trigeminal innervation, Transcutaneous auricular neurostimulation, Sparrow Ascent, Neuromodulation, Simulator adaption syndrome, Transcutaneous vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- 59th Medical WingUS federal agency
- Collaborators
- Defense Health Agency
- Study start
- 21 Feb 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 24 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 sickness in a healthy population. Study participants will be given monitoring equipment to wear during the study, which will record the participant's vital signs throughout the experiment.
Participants will be randomly assigned to one of two groups. Randomization is a process like flipping a coin and meaning there is a chance of being assigned to either of the groups. The two groups include one group where the Sparrow Ascent System™ is turned on. The second group will be given a "sham" Sparrow Ascent System™. A sham device is an inactive Spark Sparrow Therapy System™ that looks like the normal device, but that does not provide any therapy.
Participants will be given different stimuli that may cause spatial disorientation and motion sickness. This will include an electronic flight simulator and a rotating chair. In the flight simulator, participants will be given different tasks to complete that often cause some minor spatial disorientation. In the rotating chair, investigators will spin participants around at a steady rate for 10 minutes and ask the participants to change the participants head position in ways that often cause motion sickness. Before, during, and after these stimuli participants will be asked to complete a series of tests to determine if the participants are becoming susceptible to either spatial disorientation or motion sickness. These tests will include asking how the participants are feeling throughout the stimuli, written questionnaires about how the participants feel. Before and after stimuli, participants will also be asked to perform simple tasks to test the participants orientation and performance including hand-eye-coordination, object tracking, and reaction time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study is a prospective, randomized, double-blinded, sham-controlled investigation of the effects of transcutaneous auricular neurostimulation (tAN) on spatial disorientation and motion sickness. Participants will be recruited from a motion-naïve population and randomized into two groups: Group 1 (n = 18): Active tAN initiated 45-minutes before simulated disorientation Group 2 (n = 18): Passive Sham tAN Experimentation will take place in 5 stages: (Pre-experimentation) 1) prior to spatial disorientation challenge, 2) spatial disorientation challenge, 3) between challenges, 4) motion sickness challenge, 5) conclusion At the conclusion of pre-experimentation, the subjects will be placed with a tAN earpiece on their left ear. A tAN device will be programmed based on the participant study group and will be connected to the participant's earpiece.
| Arm | Type | Receives |
|---|---|---|
| Sham Transcutaneous Auricular Neurostimulation Device (Group 2) | No intervention | –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 Transcutaneous Auricular Neurostimulator Device (Group 1) | Active comparator | Device: Transcutaneous Auricular Neurostimulation deviceThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Neurostimulation deviceThe 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 | Device | Active Transcutaneous Auricular Neurostimulator Device (Group 1) |
Primary outcome
Graybiel Scale
Time frame: Baseline, and at 5- and 10-minutes post motion sickness and at 5- and 10-minutes post spatial disorientation challenges.
The Graybiel scale is a commonly used scale for identifying and rating motion sickness symptoms. It was designed to survey multiple dimensions of motion sickness characterized by the degree of 6 representative cardinal symptoms: Nausea and vomiting, skin color, cold sweating, increased salivation, drowsiness, pain and central nervous system symptoms. Each cardinal symptom category is rated by the participant and a corresponding score is calculated. Lesser symptoms are scored with lower point values, 1, 2 or 4 points depending on the severity of that particular symptom with higher scores indicating increased severity. More severe symptoms are scored 8 or 16 points. Values greater than or equal to 16 total points is categorized as frank sickness, 8 to 15 points is severe malaise, 5 to 7 points is moderate malaise A, 3 to 4 points is moderate malaise B, and 1 to 2 points is categorized as slight malaise.
8 secondary outcomes
Vitals: Blood pressure
Time frame: Baseline and immediately post spatial disorientation challenge and immediately post motion sickness challenge. At 90 minutes post motion sickness challenge.
Misery Scale (MISC)
Time frame: Baseline, and at 3 times during the spatial disorientation challenge, at 5- and 10-minutes post spatial disorientation challenge as well as 1-minute intervals during the motion sickness challenge and 5- and 10-minutes post motion sickness challenge.
Motion Sickness Assessment Questionnaire (MSAQ)
Time frame: Baseline, and 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.
Simulator sickness questionnaire (SSQ)
Time frame: Baseline and at 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.
Motion sickness susceptibility questionnaire
Time frame: Baseline
Functional Ability Assessment
Time frame: Baseline and 15 minutes post spatial disorientation challenge and 15 minutes post motion sickness challenge.
Vitals: Heart rate
Time frame: Continuously throughout the study day, starting at baseline and stopping 90 minutes post motion sickness challenge.
Vitals: Heart Rate Variability
Time frame: Continuously throughout the study day, starting at baseline and stopping 90 minutes post motion sickness challenge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- BackgroundHeinle, Todd E. and William R. Ercoline. "Spatial Disorientation: Causes, Consequences and Countermeasures for the USAF." (2003).
- BackgroundMark S. George, Ziad Nahas, Daryl E. Bohning, Qiwen Mu, F. Andrew Kozel, Jeffrey Borckhardt, Stewart Denslow, Mechanisms of action of vagus nerve stimulation (VNS), Clinical Neuroscience Research, Volume 4, Issues 1-2, 2004, Pages 71-79, ISSN 1566-2772, https://doi.org/10.1016/j.cnr.2004.06.006.
- Background: PubMed 7840743Ebenholtz SM, Cohen MM, Linder BJ; New Collective Author. The possible role of nystagmus in motion sickness: a hypothesis. Aviat Space Environ Med. 1994 Nov;65(11):1032-5.
- BackgroundRogers D, Van Syoc D. Clinical Practice Guideline for Motion Sickness. November 2011. http://www.asams. org/guidelines/Completed/NEW%20Motion%20Sickness.htm. Accessed January 11, 2022.
- BackgroundKramer MR, Wasserman EB, Teel EF, et al Effect of protective helmets on vision and sensory performance. British Journal of Sports Medicine 2017;51:A65.
- BackgroundCaserman, P., Garcia-Agundez, A., Gámez Zerban, A. et al. Cybersickness in current-generation virtual reality head-mounted displays: systematic review and outlook. Virtual Reality 25, 1153-1170 (2021). https://doi.org/10.1007/s10055-021-00513-6
- Background: PubMed 17312694Chan G, Moochhala SM, Zhao B, Wl Y, Wong J. A comparison of motion sickness prevalence between seafarers and non-seafarers onboard naval platforms. Int Marit Health. 2006;57(1-4):56-65.
- Background: PubMed 2775137Antunano MJ, Hernandez JM. Incidence of airsickness among military parachutists. Aviat Space Environ Med. 1989 Aug;60(8):792-7.
- Background: PubMed 33762918Jenkins DD, Khodaparast N, O'Leary GH, Washburn SN, Covalin A, Badran BW. Transcutaneous Auricular Neurostimulation (tAN): A Novel Adjuvant Treatment in Neonatal Opioid Withdrawal Syndrome. Front Hum Neurosci. 2021 Mar 8;15:648556. doi: 10.3389/fnhum.2021.648556. eCollection 2021.
- Background: PubMed 35978394Tirado CF, Washburn SN, Covalin A, Hedenberg C, Vanderpool H, Benner C, Powell DP, McWade MA, Khodaparast N. Delivering transcutaneous auricular neurostimulation (tAN) to improve symptoms associated with opioid withdrawal: results from a prospective clinical trial. Bioelectron Med. 2022 Aug 18;8(1):12. doi: 10.1186/s42234-022-00095-x.
- Background: PubMed 14649629Cowings PS, Toscano WB, DeRoshia C, Tauso R; New Collective Author. Effects of Command and Control Vehicle (C2V) operational environment on soldier health and performance. Hum Perf Extrem Environ. 2001 Jun;5(2):66-91.
- Background: PubMed 36841838Molefi E, McLoughlin I, Palaniappan R. On the potential of transauricular electrical stimulation to reduce visually induced motion sickness. Sci Rep. 2023 Feb 25;13(1):3272. doi: 10.1038/s41598-023-29765-9.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Isaac D Erbele, MD, ENT principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Neurostimulation device in people with Motion Sickness, run by 59th Medical Wing at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isaac D Erbele, MD, ENT (210-916-2985, isaac.d.erbele.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06892340, which also lists 23 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.