Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation

59th Medical Wing

Status: Enrolling

Conditions: Motion Sickness

Treatments: Device: Transcutaneous Auricular Neurostimulation device

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06892340

C.2024.076 FWH20240041H

ST 1186 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 2 patient groups

Sham Transcutaneous Auricular Neurostimulation Device (Group 2)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: Transcutaneous Auricular Neurostimulation device