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Acute Intermittent Hypoxia for Traumatic Brain Injury (AIH Trial)

N/A
Recruiting
Led By Jordan Grafman, PhD
Research Sponsored by Shirley Ryan AbilityLab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
When available, a Glasgow Coma Scale score between 9-15
Not involved in any other research intervention study testing neurobehavioral functioning
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session
Awards & highlights

AIH Trial Summary

This trial is studying whether it is safe for people with TBI to have their oxygen levels reduced briefly and if doing so has any effect on memory, cognition, and motor control.

Eligible Conditions
  • Traumatic Brain Injury

AIH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your Glasgow Coma Scale score, which measures your level of consciousness, should be between 9 and 15.
Select...
You are not currently participating in any other study that involves testing how your brain and behavior work.

AIH Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed and reported at the 2-minute, 6-minute, 14-minute, 24-minute, and 30-minute timepoints throughout each hypoxia session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Verbal Response to a 9-Item Subjective Symptom Checklist
Change in Vitals
Secondary outcome measures
Change in Beck Depression Inventory (BDI-II) score
Change in California Verbal Learning Test (CVLT-II) scores
Change in Effort Expenditure for Rewards Task (EEfRT) score
+10 more

AIH Trial Design

1Treatment groups
Experimental Treatment
Group I: AIH groupExperimental Treatment1 Intervention
Hypoxia will be administered via a specialized face mask attached to a gas mixing device (HYP123, Hypoxico Inc.), which controls oxygen content in inhaled air. The hypoxia administering unit will be manually adjusted to supply O2 at the target level for a given session (approximately 21%-normal room air, 17%, 13%, and 9% respectively). Each session will include 15 cycles of hypoxia, each lasting up to 60 seconds, interspersed with up to 90-second normoxic episodes. An oxygen monitor will continuously measure and record the fraction of inspired oxygen delivered (MAX-250E, Maxtec Inc.).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acute Intermittent Hypoxia
2019
N/A
~130

Find a Location

Who is running the clinical trial?

Shirley Ryan AbilityLabLead Sponsor
192 Previous Clinical Trials
14,869 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,335 Previous Clinical Trials
648,515 Total Patients Enrolled
Jordan Grafman, PhDPrincipal Investigator - Shirley Ryan AbilityLab
Shirley Ryan AbilityLab
1 Previous Clinical Trials
254 Total Patients Enrolled

Media Library

Acute Intermittent Hypoxia Clinical Trial Eligibility Overview. Trial Name: NCT04890639 — N/A
Traumatic Brain Injury Research Study Groups: AIH group
Traumatic Brain Injury Clinical Trial 2023: Acute Intermittent Hypoxia Highlights & Side Effects. Trial Name: NCT04890639 — N/A
Acute Intermittent Hypoxia 2023 Treatment Timeline for Medical Study. Trial Name: NCT04890639 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ambition of this research endeavor?

"The primary metric of this 30-minute hypoxia session is a change in verbal response to a 10-Item Subjective Symptom Checklist. Secondary outcomes include an alteration in intracortical inhibition, measured through Transcranial magnetic stimulation (TMS), and modifications in Visual Analogue Mood Scale (VAM-S) score and California Verbal Learning Test (CVLT) score."

Answered by AI

How many participants is the research team recruiting to take part in this clinical trial?

"Affirmative, clinicaltrials.gov substantiates that this study is presently recruiting participants. It was first made available on March 15th 2022 and the information was last refreshed on May 10th of the same year. The trial necessitates 16 individuals to be enrolled at a single location."

Answered by AI

Do I meet the qualifications necessary to participate in this experiment?

"This medical trial is currently seeking 16 participants that have experienced a mild to moderate TBI, ranging in age from 18 to 65. In order for applicants to be accepted into the study they must fulfill additional criteria such as possessing the ability to use a keyboard and communicate fluently in English, being able confirm negative pregnancy status (if applicable), not engaging with any other research initiatives concerning neurobehavioral functioning, and having an available Glasgow Coma Scale score between 9-15."

Answered by AI

Is there an age restriction for inclusion in this clinical investigation?

"This survey is open to patients aged 18-65. There are additional studies available for those under 18 (190) and over 65 (798)."

Answered by AI

Is recruitment for this clinical trial still available?

"Affirmative, the information on clinicaltrials.gov indicates that this medical study is presently recruiting patients. Originally posted in mid-March of 2022, with a most recent update from early May 2021; the research team are actively seeking 16 individuals to take part at one site."

Answered by AI
~5 spots leftby Mar 2025