NCT01986205|CompletedPhase 2FDA DrugFDA Device
Hyperbaric Oxygen for Traumatic and Non-traumatic Brain Injury
HYBOBI2
A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham for Persistent Symptoms After Brain Injury
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Sponsor study identifier
interventional
49
1 country
2
Study Start
September 6, 2017
Actual (reported)Primary Completion
May 31, 2022
Actual (reported)Study Completion
May 31, 2022
Actual (reported)The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after brain injury. This study will enroll 90 individuals with persistent problems 6 months to 10 years after a brain injury. These individuals will be randomized to receive either oxygen or air in a pressurized hyperbaric chamber. Participants will receive 40 daily hyperbaric chamber sessions. Participants will have a series of tests and questionnaires before they begin their chamber sessions, after they complete 40 sessions, and 6 months after they joined the study. These tests include computer-based and pencil-and-paper questionnaires and thinking tests, brain imaging, a neurological examination, and an eye exam. Participants will also be asked to provide blood for future research. After the 6-month tests are complete, all participants will receive 40 hyperbaric oxygen sessions, then undergo the same tests at 9 months and 12 months.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 31, 2022
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 31, 2013
Actual (reported)November 18, 2013
Actual (reported)September 6, 2017
Actual (reported)May 31, 2022
Actual (reported)May 31, 2022
Actual (reported)Neurobehavioral Symptom Inventory
Participant-reported symptom rating of post-concussive symptoms
13 weeks
Neurobehavioral Symptom Inventory
6 months
Incidence of myopia
13 weeks
100% oxygen at 1.5 atmospheres absolute for 60 minutes, 40 sessions
Regular air at minimal pressurization for 60 minutes, 40 sessions
Hyperbaric oxygen (USP oxygen \>99%) delivered in a hyperbaric chamber pressurized to 1.5 atmospheres absolute.
Room air delivered in a hyperbaric chamber with minimal pressurization.
Intermountain Medical Center
Murray, Utah, 84157, United States
Intermountain LDS Hospital
Salt Lake City, Utah, 84143, United States
Churchill S, Weaver LK, Deru K, Russo AA, Handrahan D, Orrison WW Jr, Foley JF, Elwell HA. A prospective trial of hyperbaric oxygen for chronic sequelae after brain injury (HYBOBI). Undersea Hyperb Med. 2013 Mar-Apr;40(2):165-93.
Lindell K. Weaver, MD
Intermountain Health Care, Inc.
49 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2013
First Posted
November 18, 2013
Study Start
September 6, 2017
Actual (reported)Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
May 31, 2022
Actual (reported)Study Completion
May 31, 2022
Actual (reported)Last Updated
August 4, 2022
Record last verified: 2022-08
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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