NCT03318822

Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: All
• Age: 14 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to assess the usability and tolerability of this jugular vein compression device in a population of helmeted and non-helmeted competitive high school, collegiate and professional athletes in the sports of football and rugby. This study differs from previous work in that it is designed to capture additional data related to the athlete experience wearing the jugular vein compression device in older and more elite playing levels.

Detailed description

Significant morbidity, mortality, and related costs are caused by traumatic brain injury (TBI). A simple, effective, and lightweight device worn by athletes or war fighters in the field, designed to mitigate TBI resulting from blast trauma or concussive events, would save lives, and the huge costs incurred for life-treatment of surviving victims. An externally-worn medical device that applies mild jugular compression according to the principle of the Queckenstedt Maneuver (the Device) is being developed by Q30 Sports Science, LLC (Q30). Preliminary research suggests that the Device has the potential to reduce the likelihood of TBI. The currently developed collar has been approved for studies in humans and the results indicate safety for use during high demand and maximal exertion activities. Regarding safety, the externally worn collar is meticulously designed to mimic the body's own omohyoid muscle actions upon the jugular veins that will provide similar pressure and volume increases not to surpass that of a yawn or the mere act of just lying down. This study will investigate the tolerability of this device in athletes participating in the competitive sports of football and rugby at the high school, collegiate or professional levels.

Conditions

• Brain Injuries, Traumatic
• Brain Injury Traumatic Mild

Interventions

Type	Name	Description
DEVICE	Q-Collar	An externally-worn medical device that applies mild jugular compression

Timeline

• Start date: 2017-08-01
• Primary completion: 2020-07-30
• Completion: 2020-12-31
• First posted: 2017-10-24
• Last updated: 2021-05-06

Locations

1 site across 1 country: United States