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Decongestant
Pseudoephedrine for Barotrauma (HBOT Trial)
N/A
Recruiting
Led By Jacinta Showers, RN
Research Sponsored by John Muir Health
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 45-60 minutes
Awards & highlights
HBOT Trial Summary
This trial studies if pseudoephedrine helps protect ears during high-pressure oxygen therapy (HBOT). It hopes to prevent ear trauma.
Who is the study for?
This trial is for new patients aged 18-79 needing Hyperbaric Oxygen Therapy (HBOT), who speak English, can make decisions, and swallow a pill. It's not for those with high heart rate or blood pressure, prisoners, pregnant women, glaucoma or heart disease patients, allergy to pseudoephedrine or on MAOIs.Check my eligibility
What is being tested?
The study tests if pseudoephedrine prevents ear damage during HBOT compared to a placebo. Pseudoephedrine relieves nasal congestion but its effectiveness in preventing barotrauma during HBOT is being researched.See study design
What are the potential side effects?
Pseudoephedrine may cause side effects like headache, dizziness, nausea, trouble sleeping and increase in blood pressure. People react differently so some might experience other less common side effects.
HBOT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 45-60 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~45-60 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Compare changes in self-reported ear pain during hyperbaric oxygen therapy
Secondary outcome measures
Incidence of completed compression
HBOT Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PseudoephedrineExperimental Treatment1 Intervention
over the counter pseudoephedrine
Group II: PlaceboPlacebo Group1 Intervention
pharmacy created placebo capsule
Find a Location
Who is running the clinical trial?
John Muir HealthLead Sponsor
2 Previous Clinical Trials
458 Total Patients Enrolled
Jacinta Showers, RNPrincipal InvestigatorJohn Muir Health
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 79 years old.I can swallow pills without any issues.I am capable of making my own health decisions.I need urgent hyperbaric therapy for a serious condition within 30 minutes.I cannot take pseudoephedrine due to pregnancy, glaucoma, heart disease, allergy, or MAOI use.I cannot swallow pills.I haven't used any decongestants or nasal sprays in the last 12 hours.I need hyperbaric oxygen therapy for the first time.
Research Study Groups:
This trial has the following groups:- Group 1: Pseudoephedrine
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applications being accepted for participation in this trial?
"According to clinicaltrials.gov, the trial is actively enrolling participants as of now. It was initially published on January 31st 2023 and has been amended most recently on March 8th 2023."
Answered by AI
How many participants are currently receiving the intervention in this clinical trial?
"Affirmative. The information available on clinicaltrials.gov indicates that recruitment for this medical trial is still ongoing, with the initial posting having been made on January 31st 2023 and last updated March 8th of the same year. This project requires 90 volunteers across a single location."
Answered by AI
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