Intermittent Hypoxia for Traumatic Brain Injury
(AIH Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJordan Grafman, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Shirley Ryan AbilityLab

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial tests if low oxygen therapy is safe and beneficial for stable TBI patients with ongoing issues. This therapy may help their brain cells grow and connect better, improving memory and motor skills.

Eligibility Criteria

This trial is for adults aged 18-65 who have had a mild to moderate TBI, can communicate in English, and are able to use a keyboard. They should not be part of another neurobehavioral study and women must confirm they're not pregnant. Excluded are those with certain heart or lung diseases, severe psychiatric disorders, learning disabilities, inability to undergo MRI or TMS, or severe hypertension.

Inclusion Criteria

Able to understand and communicate in English

Able to consent independently

Able to leave a research visit with a companion/group transportation

+6 more

Exclusion Criteria

Ischemic cardiac disease

You already have a lung condition that causes low oxygen levels.

You have a history of serious breathing problems like COPD or asthma.

+4 more

Participant Groups

The trial tests Acute Intermittent Hypoxia (AIH) on TBI survivors to see if brief periods of lower oxygen levels are safe and if they improve memory, cognition, and motor control. Participants' reactions will be closely watched during the experiments.

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.).