A Non-Invasive, Non-Sedating Device to Reduce Motion Sickness and Spatial Disorientation in Healthy Adults

What this Trial Is About

Researchers are studying how a wearable nerve stimulation device called the Sparrow Ascent System12 affects spatial disorientation and motion sickness in healthy adults. Spatial disorientation happens when the body's sense of position conflicts with actual location, involving the inner ear, eyes, body sense, and brain. This can lead to motion sickness, especially in people not used to motion. The device stimulates nerves around the ear that are linked to nausea and other sensations and is already approved by the FDA for other conditions. Participants will be randomly assigned to two groups: one receiving active stimulation from the Sparrow Ascent System12 and the other receiving a sham (inactive) version of the device that looks the same but provides no stimulation. During the study, participants will face motion challenges including tasks in an electronic flight simulator and spinning in a rotating chair while their vital signs are monitored. The stimulation settings can be adjusted for comfort. Throughout the study, participants will undergo tests before, during, and after motion challenges to assess symptoms and performance. These include questionnaires about how they feel, tasks measuring coordination and reaction time, and continuous monitoring of heart rate and blood pressure. The main measure is the Graybiel Scale recorded at multiple times after challenges. The study monitors safety and lasts through the motion challenges and assessments, with data collected up to 90 minutes after.

Evaluation of a Device to Reduce Motion Sickness and Spatial Disorientation