NCT06892340

Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: 59th Medical Wing · Federal
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Motion Sickness

Interventions

Type	Name	Description
DEVICE	Transcutaneous Auricular Neurostimulation 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

Timeline

• Start date: 2025-02-21
• Primary completion: 2025-10-31
• Completion: 2025-10-31
• First posted: 2025-03-24
• Last updated: 2025-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study