RECRUITING

Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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. 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.

Official Title

A Non-Invasive, Non-Sedating Device to Mitigate Motion Sickness and Spatial Disorientation

Quick Facts

Study Start:2025-02-21

Study Completion:2025-08-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06892340

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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. *	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

Inclusion Criteria

Exclusion 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.
*

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

Contacts and Locations

Study Contact

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

Principal Investigator

Isaac D Erbele, MD, ENT

PRINCIPAL_INVESTIGATOR

Brooke Army Medical Center

Study Locations (Sites)

Randolph AFB Physiology lab

San Antonio, Texas, 78148

United States

Collaborators and Investigators

Sponsor: 59th Medical Wing

Isaac D Erbele, MD, ENT, PRINCIPAL_INVESTIGATOR, Brooke Army Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-21

Study Completion Date2025-08-10

Study Record Updates