Purpose of this Study
We are doing this study to learn if hyperbaric oxygen therapy (HBOT) is helpful to people with traumatic brain injury.
Who Can Participate?
Eligibility
- Men and Women 16-65 years old
- Have a traumatic brain injury
- Able to complete their first hyperbaric treatment within 8-14 hours of being admitted to the hospital
- Have a traumatic brain injury
- Able to complete their first hyperbaric treatment within 8-14 hours of being admitted to the hospital
Age Range
16-65
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
If you choose to join this study you will:
- Be randomized (like drawing numbers out of a hat) to be 1 one of 8 groups
-- 6 groups will receive hyperbaric oxygen therapy (HBOT)
-- 1 group will receive a high dose of oxygen that is not pressurized
-- 1 group will get standard care
- All groups will complete a follow-up visit (on the phone or in-person) at month 3 and 6 after treatment
- Be randomized (like drawing numbers out of a hat) to be 1 one of 8 groups
-- 6 groups will receive hyperbaric oxygen therapy (HBOT)
-- 1 group will receive a high dose of oxygen that is not pressurized
-- 1 group will get standard care
- All groups will complete a follow-up visit (on the phone or in-person) at month 3 and 6 after treatment
Locations
Duke University Hospital
Visit Timing
Weekdays
Weekends
Evenings
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
Hyperbaric Oxygen Brain Injury Treatment (HOBIT) Trial: A Multicenter, Randomized, Prospective Phase II Adaptive Clinical Trial Evaluating the Most Effective Hyperbaric Oxygen Treatment Paradigm for Severe Traumatic Brain Injury
Study Website
Principal Investigator
Katharine
Colton
Protocol Number
PRO00093798
NCT ID
NCT02407028
Phase
II
Enrollment Status
OPEN TO ACCRUAL