About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Transcutaneous Auricular Neurostimulation device
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
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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59th Medical Wing
Lead sponsor
Defense Health Agency
Collaborator