Investigating how different rates of compression affect ear problems during hyperbaric oxygen treatment
Official title: The Effect of Rate (Slope) of Compression on the Incidence of Symptomatic Eustachian Tube Dysfunction and Middle Ear Barotrauma: a Phase III Prospective Study.
Run by Northwell Health · NCT04804098 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing whether different ways of compressing air can help prevent ear problems in people receiving hyperbaric oxygen treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Sleepy Hollow, New York) |
| Trial ID | NCT04804098 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients who require hyperbaric oxygen treatment and meet the necessary diagnostic criteria.
✕Probably not a fit
Patients with absolute contraindications to hyperbaric oxygen treatment or those with chronic ear conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study examines the impact of varying rates of compression on the incidence of Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) during hyperbaric oxygen therapy. Building on previous findings, the trial will randomly assign patients to receive either a linear or non-linear compression profile over a 15-minute period. Data will be collected prospectively from multiple patients treated as a group to assess the effectiveness of these compression rates in reducing complications. The goal is to determine the optimal compression method that minimizes ETD and MEB occurrences.
Why it matters
Potential benefit: If successful, this study could lead to improved protocols for hyperbaric oxygen treatment, reducing the risk of ear-related complications for patients.
How similar studies have gone: Previous studies have shown promising results regarding compression profiles in reducing ear complications, but this specific approach is being tested in a larger cohort for the first time.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: - Any patient meeting the proper diagnosis and indications to be treated with hyperbaric oxygen. Exclusion Criteria: * Any patient with absolute contraindications to hyperbaric oxygen treatment * Patients with chronic bilateral perforation of the tympanic membrane or; * A history of prior surgical placement of myringotomy tubes.
Where it's running
-
Phelps Hospital Northwell Health
Sleepy Hollow, New York, United States Recruiting
Study contacts
- Principal investigator: Owen J O'Neill, MD, MPH — Phelps Hospital Northwell Health
- Study coordinator: Owen J O'Neill, MD, MPH
- Email: ooneill@northwell.edu
- Phone: 914-366-6665
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.