Clinical trial NCT06892340: Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation
Official title: A Non-Invasive, Non-Sedating Device to Mitigate Motion Sickness and Spatial Disorientation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Motion Sickness
Spatial Disorientation
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
Lead sponsor: 59th Medical Wing
Sponsor class: FED
Collaborators: name: Defense Health Agency
First posted: 2025-03-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: * 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

Primary outcomes:
measure: Graybiel Scale
timeFrame: Baseline, and at 5- and 10-minutes post motion sickness and at 5- and 10-minutes post spatial disorientation challenges.
Secondary outcomes:
measure: Vitals: Blood pressure
timeFrame: Baseline and immediately post spatial disorientation challenge and immediately post motion sickness challenge. At 90 minutes post motion sickness challenge.
measure: Misery Scale (MISC)
timeFrame: 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.
measure: Motion Sickness Assessment Questionnaire (MSAQ)
timeFrame: Baseline, and 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.
measure: Simulator sickness questionnaire (SSQ)
timeFrame: Baseline and at 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.
measure: Motion sickness susceptibility questionnaire
timeFrame: Baseline
measure: Functional Ability Assessment
timeFrame: Baseline and 15 minutes post spatial disorientation challenge and 15 minutes post motion sickness challenge.
measure: Vitals: Heart rate
timeFrame: Continuously throughout the study day, starting at baseline and stopping 90 minutes post motion sickness challenge.
measure: Vitals: Heart Rate Variability
timeFrame: Continuously throughout the study day, starting at baseline and stopping 90 minutes post motion sickness challenge.
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Randolph AFB Physiology lab
state: Texas
Study officials:
affiliation: Brooke Army Medical Center
name: Isaac D Erbele, MD, ENT
role: PRINCIPAL_INVESTIGATOR
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