Barotrauma in Hyperbaric Oxygen Therapy (HBOT)

August 25, 2025 updated by: Jacinta Showers, John Muir Health

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pseudoephedrine
over the counter pseudoephedrine
Drug: Pseudoephedrine Pill
One-time 60mg dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy
Other Names:
  • Sudafed
Placebo Comparator: Placebo
pharmacy created placebo capsule
Drug: Placebo
One time dose given orally between 45-120 minutes prior to hyperbaric oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare changes in self-reported ear pain during hyperbaric oxygen therapy
Time Frame: 45-60 minutes
Patients to describe pain on a numerical scale before, during and after hyperbaric oxygen therapy
45-60 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of completed compression
Time Frame: 1 minute
Compare frequency of complete versus aborted hyperbaric oxygen therapy session due to pain.
1 minute

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Muir Health

Investigators

  • Principal Investigator: Jacinta Showers, RN, John Muir Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

December 26, 2022

First Submitted That Met QC Criteria

January 16, 2023

First Posted (Actual)

January 25, 2023

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 25, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-10-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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