Hyperbaric Oxygen for Civilian Post-concussive Syndrome (HYBOBI2)
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|ClinicalTrials.gov Identifier: NCT01986205|
Recruitment Status : Recruiting
First Posted : November 18, 2013
Last Update Posted : October 4, 2017
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Post-concussion Syndrome||Combination Product: Hyperbaric Oxygen Combination Product: Pressurized Air (1.2) Combination Product: Minimal pressure air||Phase 2|
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 6 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Double-blind Randomized Trial of Hyperbaric Oxygen Versus Sham in Civilian Post-concussive Syndrome|
|Actual Study Start Date :||September 6, 2017|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2020|
Experimental: Hyperbaric Oxygen
100% oxygen at 1.5 atmospheres absolute for 60 minutes, 40 sessions
Combination Product: Hyperbaric Oxygen
Hyperbaric oxygen (USP oxygen >99%) delivered in a hyperbaric chamber pressurized to 1.5 atmospheres absolute.
Sham Comparator: Pressurized Air (1.2)
Regular air at 1.2 atmospheres absolute for 60 minutes, 40 sessions
Combination Product: Pressurized Air (1.2)
Room air delivered in a hyperbaric chamber pressurized to 1.2 atmospheres absolute.
Placebo Comparator: Minimal pressure air
Regular air at minimal pressurization for 60 minutes, 40 sessions
Combination Product: Minimal pressure air
Room air delivered in a hyperbaric chamber with minimal pressurization.
Other Name: Room air
- Neurobehavioral Symptom Inventory [ Time Frame: 13 weeks ]Participant-reported symptom rating of post-concussive symptoms
- Neurobehavioral Symptom Inventory [ Time Frame: 6 months ]Participant-reported symptom rating of post-concussive symptoms
- Incidence of myopia [ Time Frame: 13 weeks ]Myopic visual changes after chamber sessions
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986205
|Contact: Susan Churchill, APRN-NPemail@example.com|
|United States, Utah|
|Intermountain Medical Center||Recruiting|
|Murray, Utah, United States, 84157|
|Contact: Susan Churchill, APRN-NP 801-408-3623 firstname.lastname@example.org|
|Principal Investigator: Lindell K. Weaver, MD|
|Intermountain LDS Hospital||Recruiting|
|Salt Lake City, Utah, United States, 84143|
|Contact: Susan Churchill, NP 801-408-3623 email@example.com|
|Principal Investigator: Lindell K Weaver, MD|
|Principal Investigator:||Lindell K. Weaver, MD||Intermountain Health Care, Inc.|