Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation

NCT06892340 | Recruiting FDA Device

• 2 other identifiers: C.2024.076 FWH20240041HST 1186
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Motion Sickness

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

Outcome Measures

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.

  Baseline, and at 5- and 10-minutes post motion sickness and at 5- and 10-minutes post spatial disorientation challenges.

Secondary Outcomes (8)

• Vitals: Blood pressure

  Baseline and immediately post spatial disorientation challenge and immediately post motion sickness challenge. At 90 minutes post motion sickness challenge.

• Misery Scale (MISC)

  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)

  Baseline, and 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.

• Simulator sickness questionnaire (SSQ)

  Baseline and at 5- and 10-minutes post spatial disorientation challenge and 5- and 10-minutes post motion sickness challenge.

• Motion sickness susceptibility questionnaire

  Baseline

Study Arms (2)

Sham Transcutaneous Auricular Neurostimulation Device (Group 2)

NO INTERVENTION

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

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

Interventions

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

Active Transcutaneous Auricular Neurostimulator Device (Group 1)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Neck pain or spinal pathology
• Medications impacting cardiac, vestibular, or neurologic function
• Recently ill or hospitalized within 30 days
• Pilots and individuals formally desensitized to motion sickness
• 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)
• Participant has a history of epileptic seizures
• Participant has a history of neurological diseases or traumatic brain injury
• 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

Sponsors & Collaborators

• 59th Medical Wing: lead
• Defense Health Agency: collaborator

Study Sites (1)

Randolph AFB Physiology lab

San Antonio, Texas, 78148, United States

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Motion Sickness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Isaac D Erbele, MD, ENT

  Brooke Army Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Isaac D Erbele, MD, ENT

CONTACT

210-916-2985; isaac.d.erbele.mil@health.mil

Craig D Nowadly, MD

CONTACT

757-784-1175; craig.d.nowadly.mil@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The participants and investigator will be blind to participant treatment group assignment. Only the research coordinator will know the treatment group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: March 24, 2025
• Study Start: February 21, 2025
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.

Locations

US (1)