NCT03205215

Hyperbaric Oxygen for Post Concussive Syndrome

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

We would like to see if Hyperbaric Oxygen can help improve the symptoms that result from Post Concussive Syndrome.

Detailed description

Purpose: The purpose of this study is to examine the role of Hyperbaric Oxygen Therapy (HBOT) in decreasing symptoms in patients with a diagnosis of chronic post concussive syndrome (PCS). Hypothesis: The study hypothesis is that HBOT will decrease symptoms measured by standard measurement tools when provided to patients who have a diagnosis of PCS and are 6 months to 36 months post injury. Study Overview: Hyperbaric oxygen therapy (HBOT) involves the administration of inhaled 100% oxygen at increased ambient pressure inside a closed vessel. HBOT produces greatly elevated arterial and tissue oxygen tensions, producing a wide variety of physiological effects at the cellular and sub cellular level. Participants will be selected from the post-concussive syndrome population based on an expectation that they would experience a clinically significant improvement. Eligible subjects will be experiencing post concussive symptoms related to an injury within the last 6 to 36 months. The study will be enrolling 150 participants and will be randomized to two different treatment arms: experimental group and a waitlist group. Each participant will receive a series of forty 2 hour treatments, delivered once a day, 5 days a week, within the hyperbaric oxygen chamber.There will be assessments completed before treatment series begins, at the end of treatment, 8 months and 14 months after treatment begins. The primary outcome will be administered at these times as well as every two weeks once treatment begins until the end of the study.

Conditions

• Post-Concussion Syndrome

Interventions

Type	Name	Description
OTHER	Hyperbaric Oxygen Therapy	100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
OTHER	Waitlist Hyperbaric Oxygen Therapy	100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks

Timeline

• Start date: 2018-09-01
• Primary completion: 2019-12-30
• Completion: 2020-06-30
• First posted: 2017-07-02
• Last updated: 2019-01-18

Locations

1 site across 1 country: Canada