Ignite Creation Date:
2024-05-06 @ 6:31 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05697328
Status:
RECRUITING
Last Update Posted:
2023-03-10
First Post:
2022-12-26
Brief Title:
Barotrauma in Hyperbaric Oxygen Therapy
Sponsor:
John Muir Health
Organization:
John Muir Health
Study Overview
Official Title:
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HBOT
Brief Summary:
The purpose of this research is to study whether the use of pseudoephedrine can help prevent middle ear trauma during HBOT Pseudoephedrine is an approved drug that is used for temporary relief of nasal or sinus pain and pressure
Detailed Description:
Subjects will be asked to take a pill pseudoephedrine or placebo between 45 and 120 minutes before hyperbaric oxygen therapy Subjects ears will be examined before and after therapy and be asked to assess ear pain There will be no further tests or procedures after completion of therapy session and ear examinations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None