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Compression Techniques for Ear Barotrauma

N/A
Recruiting
Led By Owen J O'Neill, MD, MPH
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any patient meeting the proper diagnosis and indications to be treated with hyperbaric oxygen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patients are assessed during each hyperbaric chamber compression until reaching treatment pressure/depth daily throughout the entire treatment course that varies based on diagnosis over 4-12 weeks
Awards & highlights

Study Summary

This trial is investigating whether a shorter, 15-minute compression with a slower rate (slope) is better at reducing ETD and MEB than the current standard of a longer, 30-minute compression with a faster rate.

Who is the study for?
This trial is for patients needing hyperbaric oxygen treatment, without chronic eardrum perforations or previous ear surgeries like myringotomy tubes. Those with absolute contraindications to hyperbaric oxygen are excluded.Check my eligibility
What is being tested?
The study compares two compression rates during hyperbaric treatments: a linear and a non-linear schedule over 15 minutes to reach the same pressure. It aims to find which rate better reduces ear complications by observing group treatments.See study design
What are the potential side effects?
Potential side effects may include symptoms of Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB), such as ear pain, discomfort, hearing changes, or dizziness during compression.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am eligible for hyperbaric oxygen treatment based on my diagnosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patients are assessed during each hyperbaric chamber compression until reaching treatment pressure/depth daily throughout the entire treatment course that varies based on diagnosis over 4-12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and patients are assessed during each hyperbaric chamber compression until reaching treatment pressure/depth daily throughout the entire treatment course that varies based on diagnosis over 4-12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hyperbaric oxygenation therapy
Severity of ETD/MEB when a patient has a stop/hold during compression

Trial Design

2Treatment groups
Active Control
Group I: 15 Minute Linear Compression ProfileActive Control1 Intervention
Compression Profile/Schedule 2 = 15 minute linear, Total Time Interval of Compression to treatment depth = 15 minutes Rate (slope) of compression = Linear rate of compression = 4.5 fsw/min to arrival at the treatment depth 45 fsw
Group II: 15 Minute Non-linear Compression ProfileActive Control1 Intervention
Compression Profile/Schedule 1 = 15 minute non-linear, Total Time Interval of Compression to treatment depth = 15 minutes Rate (slope) of compression = Non-Linear rate of compression = 2 fsw/min to a depth of 13 fsw, then 3 fsw/min up to a depth of 35 fsw, then 5 fsw/min to arrival at the treatment depth of 45 fsw

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor
457 Previous Clinical Trials
469,959 Total Patients Enrolled
Owen J O'Neill, MD, MPHPrincipal InvestigatorPhelps Hospital Northwell Health
3 Previous Clinical Trials
466 Total Patients Enrolled
David Dayya, DO, PhD, MPHPrincipal InvestigatorPhelps Hospital Northwell Health
2 Previous Clinical Trials
166 Total Patients Enrolled

Media Library

Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) Clinical Trial Eligibility Overview. Trial Name: NCT04804098 — N/A
Eustachian Tube Dysfunction Research Study Groups: 15 Minute Linear Compression Profile, 15 Minute Non-linear Compression Profile
Eustachian Tube Dysfunction Clinical Trial 2023: Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) Highlights & Side Effects. Trial Name: NCT04804098 — N/A
Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04804098 — N/A

Frequently Asked Questions

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

What is the participant cap for this research trial?

"Affirmative. As shown on clinicaltrials.gov, this research is currently attempting to recruit 300 volunteers from a single site. The project was initially proposed in September 2021 and most recently updated in the same month of 2022."

Answered by AI

Are there still positions vacant for this clinical experiment?

"Yes, the information on clinicaltrials.gov indicate that this medical research is actively seeking participants. This trial was originally posted on September 20th 2021 and has since been updated as of September 29th 2022. 300 patients are being recruited from a single site."

Answered by AI
~57 spots leftby Oct 2024