Hyperbaric Oxygen Therapy: Safety and Efficacy for Concussio
- Conditions
- Sports-Related Brain ConcussionconcussionD001924
- Registration Number
- JPRN-jRCTs032210243
- Lead Sponsor
- Sasahara Jun
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 20
1) 18 years old and older, both sexes, diagnosed with a consussion at the Teikyo University Sports Medical Science Clinic after receiving impacts to the head, face, neck, or other body parts while playing sports
2) Still showing symptoms of consussion such as headache at a time of visit to the clinic
3) Available for brain MRI or CT at a time of visit to the clinic
4) Able to start HBO therapy within 3 days after the injury
5) Signed written informed consent
1) Cases with possible structural damage, such as intracranial hemorrhage, pneumocephalus and inner ear bubbles, on image examinations.
2) Cases with safety concerning symptoms for HBO therapy, such as loss of consciousness or multiple instances of vomiting
3) Cases with disorientation and normal decision making impacted
4) Cases with inner ear injury or those patients who cannot relieve ear pressure
5) Cases with pneumothorax on chest X-ray, untreated pheumothorax, surgical history on the chest, or chronic bronchial athma
6) Cases with history of eye surgery for retinal detachment, or cases being treated with gas applied to their eye's
7) Claustrophobia
8) Pregnant women or possibly pregnant women
9) Cases with nasal obstruction or upper respiratory tract symptoms
10) Cases considered by the investigator or any sub-investigator as inappropriate for this study for any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of cases with serious adverse events or other significant adverse events from baseline to the end of the three days HBO therapy
- Secondary Outcome Measures
Name Time Method