Transmyringeal ventilation tube insertion for unilateral Menière's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial.

Background: Menière's disease is an idiopathic disorder characterized by recurrent episodes of vertigo lasting more than 20 min, unilateral sensorineural hearing loss, and tinnitus. If vertigo attacks occur frequently, the patient is usually severely incapacitated. Currently, there is no consensus on the treatment of Menière's disease. The evidence regarding most treatment options is sparse due to a lack of randomized trials together with an often-spontaneous relief over time and a considerable placebo effect. Insertion of a transmyringeal tube is a simple and relatively safe, minimally invasive procedure and previous open-label trials have shown promising results.

Study Design: This is a prospective, sham-controlled, double-blinded, randomized, clinical trial.

Aim: This trial aims to assess the effects of inserting a ventilation tube into the tympanic membrane compared with sham treatment for definite or probable unilateral Menière's disease according to the criteria formulated by the Classification Committee of the Bàràny Society.

Outcomes: The primary outcome will be the number of spontaneous vertigo attacks lasting more than 20 min and time to treatment failure. In addition to the primary outcome, we will assess various secondary outcomes related to hearing, ear fullness, dizziness, and serious adverse events.

Sample Size: An estimated 104 participants in total or 52 participants in each group will be necessary. The primary analysis will be according to the intention-to-treat principle. The trial will be initiated in 2021 and is expected to end in 2025.

Trial Status: ClinicalTrials.gov : NCT04835688 . Registered on April 8, 2021.

Protocol Version: 1.8, 26-09-2022. Date of first enrollment: October 1st, 2021. End of study: anticipated January 2025.