NCT05697328

Barotrauma in Hyperbaric Oxygen Therapy

Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: John Muir Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barotrauma

Interventions

Type	Name	Description
DRUG	Pseudoephedrine Pill	One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
DRUG	Placebo	One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

Timeline

• Start date: 2023-01-31
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2023-01-25
• Last updated: 2025-08-27

Locations

1 site across 1 country: United States