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In-office balloon dilation for baro-challenge-induced Eustachian tube dysfunction: study protocol for a randomized
Mohammad Aleinati1, Jennifer L Spiegel2,3,4, Trung N Le2,3
1Section of Otolaryngology-Head and Neck Surgery, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.
Trials
|June 18, 2026
Summary
Balloon dilation of the Eustachian tube (BDET) is being tested against a sham procedure for baro-challenge-induced Eustachian tube dysfunction (BCETD). This blinded, sham-controlled trial aims to provide high-quality evidence on BDET efficacy for BCETD symptoms.
Area of Science:
- Otolaryngology
- Medical Devices
- Clinical Trials
Background:
- Eustachian tube dysfunction (ETD) affects many individuals, with baro-challenge-induced ETD (BCETD) presenting unique diagnostic and therapeutic challenges.
- Current evidence for balloon dilation of the Eustachian tube (BDET) in treating BCETD is limited, necessitating rigorous investigation.
- The subjective nature of BCETD symptoms underscores the need for blinded, sham-controlled studies to ensure reliable outcome assessment.
Purpose of the Study:
- To evaluate the efficacy of BDET compared to a sham procedure in alleviating symptoms of BCETD.
- To test the hypothesis that BDET is superior to a sham intervention for BCETD symptom reduction.
Main Methods:
- A randomized, sham-controlled, multicenter trial involving adults with BCETD who have failed conservative management.
- Participants will be randomized to undergo either BDET or a sham procedure in an office setting under local anesthesia.
- Primary outcome is the change in BCETDQ-7 scores at 6 weeks; secondary outcomes include ETDQ-7, middle ear equalization ability, quality of life (EQ-5D-5L), and activity impairment, assessed up to 52 weeks.
Main Results:
- This section will report the primary and secondary outcome results comparing BDET and sham procedures at various follow-up points.
- Statistical analysis will determine if BDET shows a significant improvement in BCETD symptoms compared to the sham intervention.
- Data on patient-reported outcomes, including symptom severity and quality of life, will be analyzed to assess treatment effectiveness.
Conclusions:
- BDET presents a potential minimally invasive option for BCETD patients refractory to medical treatment.
- This study represents the first blinded, sham-controlled trial investigating BDET for BCETD, aiming to mitigate bias and enhance outcome reliability.
- Positive findings could establish BDET as a novel therapeutic approach, addressing a significant unmet need in BCETD management.