An observational study in Brain Injuries, Traumatic and Brain Injury Traumatic Mild, sponsored by Emory University. Completed at 1 site in United States. Open to participants aged 14 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-05-06.
Sponsored by Emory University · Observational
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.
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.
Normal healthy volunteers aged 14-49
Exclusion Criteria:
Subjects wearing the Q-Collar
Device: Q-Collar
An externally-worn medical device that applies mild jugular compression
Tolerability of collar usage
measure subject tolerability to wearing the device via weekly survey
Time frame: 1 year
Compliance of collar usage
measure subject compliance to wearing the device via weekly survey completion
Time frame: 1 year
Plan to share: No
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Emory University