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Pseudoephedrine Prophylaxis for Ear Barotrauma

Phase 4
Waitlist Available
Led By Siamak Moayedi, MD
Research Sponsored by University of Maryland, Baltimore
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 minutes
Awards & highlights

Study Summary

This trial will test whether the medication pseudoephedrine can help prevent a common complication of hyperbaric oxygen therapy called middle ear barotrauma.

Who is the study for?
This trial is for new patients aged 18-79 needing hyperbaric oxygen therapy who can swallow pills and make their own decisions. They must speak English and not have used decongestants recently or have certain health issues like high heart rate, blood pressure, glaucoma, heart disease, or be pregnant.Check my eligibility
What is being tested?
The study tests if Pseudoephedrine prevents ear pain from pressure changes in hyperbaric oxygen therapy compared to a placebo. Patients are randomly assigned to receive either the drug or a dummy pill without knowing which one they get.See study design
What are the potential side effects?
Pseudoephedrine may cause side effects such as increased heart rate, nervousness, dizziness, sleep problems and headaches. It's important to note that individual reactions can vary.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Requirement of Oxymetalozine rescue for ear pain during Hyperbaric Therapy compression
Secondary outcome measures
Middle Ear barotrauma documentation based on otoscopy
Patient description of ear pain

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pseudoephedrine GroupExperimental Treatment2 Interventions
Patients randomized to pseudoephedrine prior to hyperbaric therapy
Group II: Placebo GroupPlacebo Group2 Interventions
Patients randomized to placebo prior to hyperbaric therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pseudoephedrine 60 MG
2021
Completed Phase 4
~110
Hyperbaric Oxygen Therapy
2016
Completed Phase 4
~720

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor
688 Previous Clinical Trials
374,551 Total Patients Enrolled
Siamak Moayedi, MDPrincipal Investigator - University of Maryland School of Medicine, Department of Emergency Medicine
Mercy Medical Center, St Paul Place Specialists Inc
University Of Maryland School Of Medicine (Medical School)
Thos Jefferson University Hospital (Residency)
1 Previous Clinical Trials
600 Total Patients Enrolled

Media Library

Hyperbaric Oxygen Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04332211 — Phase 4
Ear Barotrauma Research Study Groups: Pseudoephedrine Group, Placebo Group
Ear Barotrauma Clinical Trial 2023: Hyperbaric Oxygen Therapy Highlights & Side Effects. Trial Name: NCT04332211 — Phase 4
Hyperbaric Oxygen Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04332211 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any past studies been conducted to assess Pseudoephedrine 60 MG?

"Currently, two studies investigating Pseudoephedrine 60 MG are active. One trial is in its final phase and the majority of locations for this research are based in Baltimore, Maryland with one additional site participating."

Answered by AI

Does the FDA sanction the use of Pseudoephedrine 60 MG?

"Taking into account the fact that Pseudoephedrine 60 MG is a Phase 4 treatment, which implies it has been approved by regulatory bodies, our team at Power assigned it a safety rating of 3."

Answered by AI

What are the indications for Pseudoephedrine 60 MG?

"Pseudoephedrine 60 MG can be prescribed to alleviate pain, catarrh and rhinorrhoea."

Answered by AI

Are there any open opportunities for enrolment in this trial?

"Affirmative. Clinicaltrials.gov data attests that this research project, originally posted on May 1st 2021, is currently searching for participants. To complete the study 90 people must be enrolled from a single medical centre."

Answered by AI

How many participants are currently a part of this research?

"Absolutely, the information accessible on clinicaltrials.gov verifies that this research is still recruiting volunteers. First posted in May 2021 and recently updated in October 2022, the experiment requires 90 participants from 1 centre."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
University of Maryland Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy
Siamak Moayedi, MD 2021. "Pseudoephedrine Prophylaxis for Prevention of Middle Ear Barotrauma in Hyperbaric Oxygen Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04332211.
~27 spots leftby Apr 2025
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