Acute Intermittent Hypoxia in Traumatic Brain Injury
Completed · Not applicable
Conditions studied: Brain Injuries, Traumatic
In brief
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.
Key facts
- Study ID
- NCT04890639
- Run by
- Shirley Ryan AbilityLab
- People needed
- 12
- Starts
- 2022-03-15
- Expected to finish
- 2024-01-29
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Shirley Ryan AbilityLab — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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