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Barotrauma in Hyperbaric Oxygen Therapy

NCT05697328 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-27

No results posted yet for this study

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.

Conditions

  • Barotrauma

Interventions

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

Sponsors & Collaborators

  • John Muir Health

    lead OTHER

Principal Investigators

  • Jacinta Showers, RN · John Muir Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-31
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05697328 on ClinicalTrials.gov