In-office balloon dilation for baro-challenge-induced Eustachian tube dysfunction: study protocol for a randomized sham-controlled trial

BACKGROUND: Balloon dilation of the Eustachian tube (BDET) is a potential treatment for Eustachian tube dysfunction (ETD). However, high-quality evidence for its efficacy in baro-challenge-induced ETD (BCETD) is lacking. Blinded, sham-controlled trials are critical in this context, particularly given the largely subjective nature of this condition. The objective of this study protocol is to test the hypothesis that BDET is superior to a sham procedure in reducing symptoms of BCETD. METHODS: This randomized, sham-controlled, multicenter trial will be conducted at multiple tertiary care centers in Canada. Adults experiencing BCETD symptoms and have failed conservative management will be randomized to undergo BDET or a sham procedure. The BDET group will undergo in-office balloon dilation under local anesthesia, while the sham group will undergo an in-office sham procedure. The primary outcome measure is the change in BCETD symptom severity as measured by the 7-item baro-challenge-induced Eustachian tube dysfunction questionnaire (BCETDQ-7), an adapted version of the 7-Item Eustachian tube dysfunction questionnaire (ETDQ-7), at 6 weeks post-procedure. Secondary outcomes include the ETDQ-7, ability to perform a middle ear pressure equalization maneuver, health-related quality of life (EQ-5D-5L questionnaire), and subjective work and activity impairment. Outcome measures will be assessed at baseline and at 6-, 24-, and 52-weeks post-procedure. DISCUSSION: BDET may offer a minimally invasive therapeutic option for BCETD patients who fail medical management, but the lack of blinded and sham-controlled studies limits the reliability of patient-reported outcomes. This trial will offer the first blinded and sham-controlled study of BDET in the BCETD population. This design aims to reduce bias and improve the reliability of patient-reported outcomes. Upon study completion and data analysis, we intend to publish our findings in a peer-reviewed journal. If BDET is found to be effective, it may offer a novel, minimally invasive treatment option for BCETD, addressing a critical gap in management of this population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05719207. Registered on 01/15/2023.