Hyperbaric Oxygen for Civilian Post-concussive Syndrome (HYBOBI2)
The purpose of this study is to examine whether 40 hyperbaric oxygen sessions has effect on long-term symptoms after concussion. This study will enroll 90 individuals with persistent problems 1-5 years after a mild traumatic 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 12 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.
|Post-concussion Syndrome||Drug: Hyperbaric Oxygen Drug: Pressurized Air (1.2) Drug: Pressurized Air (1.0)||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham in Civilian Post-concussive Syndrome|
- Neurobehavioral Symptom Inventory [ Time Frame: 13 weeks ]
- Neurobehavioral Symptom Inventory [ Time Frame: 12 months ]
- Incidence of myopia [ Time Frame: 13 weeks ]
|Study Start Date:||November 2016|
|Estimated Study Completion Date:||December 2020|
|Estimated Primary Completion Date:||December 2019 (Final data collection date for primary outcome measure)|
Experimental: Hyperbaric Oxygen
100% oxygen at 1.5 atmospheres absolute for 60 minutes, 40 sessions
Drug: Hyperbaric Oxygen
Sham Comparator: Pressurized Air (1.2)
Regular air at 1.2 atmospheres absolute for 60 minutes, 40 sessions
|Drug: Pressurized Air (1.2)|
Placebo Comparator: Pressurized Air (1.0)
Regular air at 1.0 atmospheres absolute for 60 minutes, 40 sessions
Drug: Pressurized Air (1.0)
Other Name: Sea level air
This is a single center, randomized, double-blind study to explore whether a course of hyperbaric oxygen can ameliorate persistent post-concussive symptoms after mild traumatic brain injury. In this study, civilian adult men and women with persistent symptoms 1 to 5 years after injury will be randomized to receive 40 hyperbaric oxygen sessions (100% oxygen at 1.5 atmospheres absolute for 60 minutes) or sham chamber sessions (room air at 1.2 atmospheres absolute or room air at sea level pressure, for 60 minutes). Chamber sessions will be provided Monday through Friday, excluding holidays, and participants will have up to 12 weeks to complete their 40 sessions.
Participants will be evaluated before the chamber sessions, at 13 weeks, and at 12 months. Assessments include self-administered questionnaires, neuropsychological function, neuroimaging, a brief neurological examination, and a neuro-optometry evaluation. These outcome tools will measure symptoms and deficit at the time of enrollment and subsequent evaluations, and provide insight into whether hyperbaric oxygen can play a role in recovery from mild traumatic brain in-jury.
Participants will be asked to provide blood for long-term storage of serum, plasma, and DNA for future investigations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01986205
|Contact: Susan Churchill, APRN-NPfirstname.lastname@example.org|
|United States, Utah|
|Intermountain Medical Center||Not yet recruiting|
|Murray, Utah, United States, 84157|
|Contact: Susan Churchill, APRN-NP 801-408-3623 email@example.com|
|Principal Investigator: Lindell K. Weaver, MD|
|Principal Investigator:||Lindell K. Weaver, MD||Intermountain Health Care, Inc.|