Balloon Dilation for Eustachian Tube Dysfunction

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byJustin Lui, MD, FRCSC

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Calgary

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a procedure called balloon dilation of the eustachian tube for adults with ear pressure problems that haven't improved with other treatments. The procedure uses a small balloon to widen the eustachian tube, helping it work better and reduce symptoms. Balloon dilation of the eustachian tube (BDET) is a commonly performed procedure.

Eligibility Criteria

This trial is for individuals with persistent eustachian tube dysfunction who haven't improved after using nasal sprays or decongestants, or those experiencing barotitis media symptoms regularly. Participants must have documented ear drum movement issues and a history of related symptoms like ear pain, pressure, hearing changes, tinnitus, or vertigo.

Inclusion Criteria

I have had ear pain, pressure, hearing issues, or tinnitus for over 3 months.

ETDQ7 ≥ 2.1 at enrollment

My ear symptoms improved within 3 days after treatment.

+4 more

Participant Groups

The study tests if balloon dilation of the eustachian tube is more effective than a sham (placebo) procedure in treating eustachian tube dysfunction. Patients will be randomly assigned to one of the procedures and followed up with various assessments over a year.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Balloon dilation of eustachian tubeExperimental Treatment1 Intervention

These patient will undergo balloon dilation dilation of the eustachian tube.

Group II: Sham procedurePlacebo Group1 Intervention

These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated.