Barotrauma in Hyperbaric Oxygen Therapy

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Barotrauma

In brief

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.

Key facts

Study ID

NCT05697328

Run by

John Muir Health

People needed

90

Starts

2023-01-31

Expected to finish

2026-07-01

Last updated by the study team

2025-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• New patient requiring HBOT (either inpatient or outpatient)
• Age greater than or equal to 18 years and less than 80 years
• Fluent in English
• Full decision capacity
• Able and medically cleared to swallow a pill

You may not qualify if…

• Enrollment would delay hyperbaric therapy more than 30 minutes in patients with emergent indications (example: Central Retinal Arterial Occlusion, Carbon Monoxide, Air Gas Embolism)
• Contraindication to pseudoephedrine (monoamine oxidase inhibitors (MAOI) use, pregnancy, glaucoma, heart disease, allergy to drug class)
• Systolic Blood Pressure >160
• Diastolic Blood Pressure > 90
• Heart Rate >100
• Decongestant/antihistamine/pseudoephedrine/nasal steroid/oxymetazoline use within 12 hours.
• Prisoner
• Intubated
• Unable to swallow oral medications

Where it is running

• John Muir Health — Walnut Creek, California, United States (enrolling)

Full record on ClinicalTrials.gov

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