Acute Intermittent Hypoxia in Traumatic Brain Injury
United States12 participantsStarted 2022-03-15
Plain-language summary
This study is designed to answer questions related to safety and preliminary efficacy of Acute Intermittent Hypoxia (AIH) in Traumatic Brain Injury (TBI) survivors. First, we aim to establish whether brief reductions in inhaled oxygen concentration can be safely tolerated in TBI survivors. Second, we aim to establish whether there are any effects of AIH on memory, cognition, and motor control. Participants will be monitored closely for any adverse events during these experiments. Data will be analyzed to determine if there is an improvement in key outcomes at any dose level.
Who can participate
Age range
18 Years – 65 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:
* Aged 18-65 years
* A first time, mild to moderate traumatic brain injury (TBI) confirmed by medical records
* When available, a Glasgow Coma Scale score between 9-15
* Able to use a keyboard
* Able to understand and communicate in English
* Able to consent independently
* Able to leave a research visit with a companion/group transportation
* Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study
* Not involved in any other research intervention study testing neurobehavioral functioning
Exclusion Criteria:
* Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
* Severe aphasia, preventing a participant from understanding the protocol and consent form
* Pre-existing hypoxic pulmonary disease
* Severe hypertension (\>160/100)
* Medically documented history of obstructive lung diseases \[e.g., Chronic obstructive pulmonary disease (COPD) or significant asthma\]
* Ischemic cardiac disease
* Ineligible to undergo MRI or TMS
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Change in Vitals at Visit 2
Timeframe: Visit 2 (AIH session #1, 21% O2, sham), conducted 1-6 days after baseline assessment in Visit 1
2
Change in Vitals at Visit 3
Timeframe: Visit 3 (AIH session #2, 17% O2), conducted 1-5 days after Visit 2 (i.e., 2-7 days after baseline)
3
Change in Vitals at Visit 4
Timeframe: Visit 4 (AIH session #3, 13% O2), conducted 1-5 days after Visit 3 (i.e., 6-12 days after baseline)
4
Change in Vitals at Visit 5
Timeframe: Visit 5 (AIH session #4, 9% O2), conducted 2-6 days after Visit 4 (i.e., 8-14 days after baseline)
5
Change in Symptoms at Visit 2
Timeframe: Visit 2 (AIH session #1, 21% O2, sham), conducted 1-6 days after baseline assessment in Visit 1
6
Change in Symptoms at Visit 3
Timeframe: Visit 3 (AIH session #2, 17% O2), conducted 1-5 days after Visit 2 (i.e., 2-7 days after baseline)