RECRUITING

Acute Intermittent Hypoxia in Traumatic Brain Injury

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Conditions

Brain Injuries, TraumaticHypoxia

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Safety and Cognitive Effects of Acute Intermittent Hypoxia-Induced Neuroplasticity in Traumatic Brain Injury

Quick Facts

Study Start:2022-03-15
Study Completion:2024-11-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04890639

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Aged 18-65 years
  2. * A first time, mild to moderate traumatic brain injury (TBI) confirmed by medical records
  3. * When available, a Glasgow Coma Scale score between 9-15
  4. * Able to use a keyboard
  5. * Able to understand and communicate in English
  6. * Able to consent independently
  7. * Able to leave a research visit with a companion/group transportation
  8. * Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study
  9. * Not involved in any other research intervention study testing neurobehavioral functioning
  1. * Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
  2. * Severe aphasia, preventing a participant from understanding the protocol and consent form
  3. * Pre-existing hypoxic pulmonary disease
  4. * Severe hypertension (\>160/100)
  5. * Medically documented history of obstructive lung diseases \[e.g., Chronic obstructive pulmonary disease (COPD) or significant asthma\]
  6. * Ischemic cardiac disease
  7. * Ineligible to undergo MRI or TMS

Contacts and Locations

Study Contact

Katya Delikishkina, PhD
CONTACT
312-238-4579
kdelikishk@sralab.org

Principal Investigator

Jordan Grafman, PhD
PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab

Study Locations (Sites)

Shirley Ryan AbilityLab
Chicago, Illinois, 60611
United States

Collaborators and Investigators

Sponsor: Shirley Ryan AbilityLab

  • Jordan Grafman, PhD, PRINCIPAL_INVESTIGATOR, Shirley Ryan AbilityLab

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-03-15
Study Completion Date2024-11-01

Study Record Updates

Study Start Date2022-03-15
Study Completion Date2024-11-01

Terms related to this study

Keywords Provided by Researchers

  • Hypoxia

Additional Relevant MeSH Terms

  • Brain Injuries, Traumatic