Status:
RECRUITING
Acute Intermittent Hypoxia in Traumatic Brain Injury
Lead Sponsor:
Shirley Ryan AbilityLab
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Brain Injuries, Traumatic
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Detailed Description
The purpose of this study is to determine whether Acute Intermittent Hypoxia (AIH) is safe to administer to medically stable chronic traumatic brain injury (TBI) patients. There is evidence indicating...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04890639
Start Date
March 15 2022
End Date
November 1 2024
Last Update
April 18 2024
Active Locations (1)
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1
Shirley Ryan AbilityLab
Chicago, Illinois, United States, 60611