Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
Sponsor59th Medical Wing

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous Auricular Neurostimulation device

    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

Treatment groups

36 Participants
are divided into 2 treatment groups
Group A: Sham Transcutaneous Auricular Neurostimulation Device (Group 2)No intervention 0 interventions
Group B: Active Transcutaneous Auricular Neurostimulator Device (Group 1)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

59th Medical Wing

Lead sponsor

Defense Health Agency

Collaborator