Barotrauma in Hyperbaric Oxygen Therapy

Part of paid clinical trials in Walnut Creek, California.

Sponsor
John Muir Health
Study ID
NCT05697328
Status
Recruiting
Apply to this trial

Conditions

  • Barotrauma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jan 31, 2023
Status verified
Aug 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Pseudoephedrine
    over the counter pseudoephedrine
  • Placebo Comparator: Placebo
    pharmacy created placebo capsule

Primary Outcome Measure

Compare changes in self-reported ear pain during hyperbaric oxygen therapy [ Time Frame: 45-60 minutes ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
John Muir HealthWalnut CreekCalifornia94598
Jacinta Showers, RN
[email protected]
9259473212
Todd Kessinger, MD
[email protected]
9259473212
Jacinta Showers, RN (PRINCIPAL_INVESTIGATOR)
Todd Kessinger, MD (SUB_INVESTIGATOR)

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John Muir Health· Walnut Creek, CA

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