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Search / Trial NCT04890639

Acute Intermittent Hypoxia in Traumatic Brain Injury

Launched by SHIRLEY RYAN ABILITYLAB · May 12, 2021

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Hypoxia

ClinConnect Summary

This clinical trial is exploring a new approach to help people who have suffered a mild to moderate traumatic brain injury (TBI). The researchers are studying a technique called Acute Intermittent Hypoxia (AIH), which involves briefly lowering the amount of oxygen inhaled. The goal is to see if this method is safe for TBI survivors and whether it might improve their memory, thinking skills, and movement. Participants will be closely monitored throughout the study to ensure their safety.

To be eligible for this trial, individuals must be between 18 and 65 years old and have experienced a first-time mild to moderate TBI, as confirmed by medical records. Participants should be able to communicate in English and understand the study details, as well as have someone to assist them after visits. However, those with certain medical conditions, such as severe lung diseases or significant heart problems, cannot participate. If you or a loved one is interested in this study, it could provide valuable insights into new ways to support recovery after a brain injury.

Gender

ALL

Eligibility criteria

  • 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

About Shirley Ryan Abilitylab

Shirley Ryan AbilityLab is a leading research and rehabilitation institute dedicated to advancing the science of physical medicine and rehabilitation. Based in Chicago, Illinois, the organization integrates clinical care, research, and education to enhance the quality of life for individuals with disabilities and chronic conditions. Known for its innovative approach, Shirley Ryan AbilityLab conducts clinical trials that aim to develop and evaluate cutting-edge therapies and technologies, fostering a collaborative environment that bridges the gap between laboratory research and patient care. Through its commitment to excellence, the institute strives to empower patients and improve outcomes in rehabilitation medicine.

Locations

Chicago, Illinois, United States

Patients applied

0 patients applied

Trial Officials

Jordan Grafman, PhD

Principal Investigator

Shirley Ryan AbilityLab

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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