An interventional study of Transcutaneous Auricular Neurostimulation device in Motion Sickness, sponsored by 59th Medical Wing. Recruiting at 1 site in United States. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-15.
Sponsored by 59th Medical Wing · Not applicable, Interventional, and Prevention
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.
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.
50 studies on the registry are indexed under Motion Sickness; 9 are open to participants now.
This study's planned enrollment of 36 is below the median of 59 across 44 interventional studies indexed under Motion Sickness.
Browse Motion Sickness studies →59th Medical Wing is the lead sponsor of 23 studies on the registry; 2 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Healthy males and non-pregnant females between the ages of 18-50 who do not experience symptoms of motion sickness.
Females who are pregnant
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Device: 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
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.
Time frame: Baseline, and at 5- and 10-minutes post motion sickness and at 5- and 10-minutes post spatial disorientation challenges.
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.
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)
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.
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)
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.
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)
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.
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
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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Continuously throughout the study day, starting at baseline and stopping 90 minutes post motion sickness challenge.
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: After publication to 6 years after publication.
Access criteria: Researchers may contact the principal investigator for access. Available data will include subject demographics, study group, and instruments values.
Started Feb 2025 (actual). Primary completion is estimated for Oct 2025, 8 months after the start.
Of 15 interventional studies with no phase under Motion Sickness, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 29. This study's planned 8 months is below that.
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