Usability and Tolerability of Novel Protection Device Against Potential Brain Injury During Competitive Sport
2 other identifiers
observational
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
August 21, 2017
CompletedFirst Posted
Study publicly available on registry
October 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedMay 6, 2021
May 1, 2021
3 years
August 21, 2017
May 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tolerability of collar usage
measure subject tolerability to wearing the device via weekly survey
1 year
Secondary Outcomes (1)
Compliance of collar usage
1 year
Study Arms (1)
Q-Collar
Subjects wearing the Q-Collar
Interventions
Eligibility Criteria
Normal healthy volunteers aged 14-49
You may qualify if:
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant in collegiate/professional sports of football or rugby
You may not qualify if:
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
- Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension)
- Hydrocephalus
- Recent penetrating brain trauma (within 6 months)
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Children's Hospital Medical Center, Cincinnaticollaborator
Study Sites (1)
Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory D Myer, PhD
Cincinnati Childrens Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
August 21, 2017
First Posted
October 24, 2017
Study Start
August 1, 2017
Primary Completion
July 30, 2020
Study Completion
December 31, 2020
Last Updated
May 6, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share