CompletedNot Applicable

The Role of Hypoxia on Subconcussive Head Impacts

United States10 participantsStarted 2018-10-22

Plain-language summary

The purpose of this study is to examine the combined effects of hypoxia and a short bout of subconcussive head impacts on neurocognitive and ocular-motor function and plasma expression of brain-derived blood biomarkers.

Who can participate

Age range

18 Years – 26 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Between 18 and 26 years old * Current or former soccer player (i.e., collegiate, intramural, club, professional) * At least 3 years of soccer heading experience * Participants can read and speak English * Participants have cell phone or computer with internet access to schedule for follow-up visits via email or text message * Participant is willing to refrain from participating in any sport activity that purposefully uses one's head to maneuver (American football, ice-hockey, rugby, wrestling, and soccer heading) during study participation Exclusion Criteria: * Any head, neck, or face injury in the 1 year prior to the study (e.g., concussion, eye injury) * History of vestibular, ocular, or vision dysfunction (e.g., macular degeneration) * Currently taking any medications that trigger drowsiness * Pregnancy * Any history of neurological disorders (e.g., seizure disorders, closed head injuries with loss of consciousness greater than 15 minutes, CNS neoplasm, spinal cord injury/surgery, history of stroke) * Lower extremity injury that would prohibit normal walking * Metal implants in the head Conditional Exclusion Criteria Based on participants' self report: those who meet any of the following criteria, he/she will be either excluded or rescheduled (if they still wish to participate in the study): * Slept less than 4 hours during the night prior to the testing day * Consumed more than 3 alcoholic drinks within 24h prior to testing * Used recreational …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study looked at how low-oxygen conditions affect brain function after repeated soccer-style heading — could the findings about blood biomarkers and eye-tracking changes after subconcussive impacts be relevant to my own history of head impacts or current brain health concerns?
2Since this trial is already completed, has my doctor seen or can they help me find the published results showing whether hypoxia made neurocognitive or convergence function worse immediately after heading — and what might that mean for someone in my situation?
3The study measured brain-derived biomarkers in the blood right after heading impacts — are any of those same biomarkers something my doctor could or should test for in my own evaluation?
4Given that this was a research study rather than a treatment trial, is there a related treatment study or clinical program my doctor would recommend if subconcussive head impact effects are a concern for me?
5This trial focused on the acute effects right at the zero-hour mark after heading — does my doctor think the short-term window they measured is the most important timeframe for brain recovery, or should I also be asking about longer-term monitoring after head impacts?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Acute change in neurocognitive function from pre-heading at 0 hour post-heading

Timeframe: Neurocognitive function will be assessed at pre- and 0 hour post-heading

Acute change in convergence function from pre-heading at 0 hour post-heading

Timeframe: Conversion function will be assessed at pre- and 0 hour post-heading

Acute change in brain-derived blood biomarkers from pre-heading at 0 hour post-heading

Timeframe: Blood samples will be collected at pre- and 0 hour post-heading

Trial details

NCT IDNCT04624152

SponsorIndiana University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-04-02

View on ClinicalTrials.gov More Trauma, Brain trials