Balloon Dilation Treatment for Eustachian Tube Dysfunction Compared to Placebo in Adults A Randomized, Double-Blind Trial Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are studying the use of balloon dilation of the eustachian tube to treat adults with eustachian tube dilatory dysfunction ETDD, including chronic and baro-challenge types. This condition can cause long-term ear problems due to negative middle ear pressure, and current treatments like steroid sprays or ear tubes may be ineffective or carry risks. The study aims to see if balloon dilation works better than a placebo, identify which patients respond well, and confirm the safety of the procedure. Participants will be randomly assigned to receive either balloon dilation of the eustachian tube or a sham procedure that mimics the motions without actual dilation. The balloon dilation is done in-office using specialized devices under local anesthesia or under general anesthesia if needed. Those in the placebo group will have the option to receive balloon dilation six weeks later. Follow-up visits occur at 6, 24, and 52 weeks to monitor progress. During the study, participants complete questionnaires about their ear symptoms, quality of life, and work impact. They will also undergo hearing tests, ear drum movement assessments, tympanometry, and visual ear examinations before and after the procedures at specified intervals. Researchers will measure changes in symptom scores, hearing, ear drum position, and ability to equalize ear pressure to evaluate treatment effects and safety over one year.

Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction