Ventilation Tube Insertion for Unilateral Menière's Disease

Casper Grønlund Larsen

Status: Unknown

Conditions: Meniere Disease

Treatments: Procedure: Sham-treatment; Procedure: Transmyringeal ventilation tube insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT04835688

CG1-2021

Details and patient eligibility

About

The purpose of this trial is to assess the effects of transmyringeal ventilation tubes compared with sham-treatment which do not ventilate the middle ear, on the number of vertigo attacks lasting more than 20 minutes in participants with Menière's disease.

Full description

Menière's disease is an inner ear disorder with recurrent attacks of vertigo, fluctuating sensorineural hearing loss, tinnitus, and aural fullness. The underlying pathogenetic mechanisms are not known. The pathologic-anatomic correlate of the disease is endolymphatic hydrops, i.e. distension of the endolymphatic spaces as seen at post-mortem microscopic examination of the temporal bone. Prevalence-figures are in the range between 0.1% to 0.5% in the population. In Denmark, the estimated prevalence of Menière's disease is 3500. The disease commonly begins in the fourth or fifth decade of life, and the prevalence increases with age.

There are a great number of different treatment options for Menière's disease including diuretics, sodium-restriction, beta-histidine, and psycho-supportive means, most of which are not validated. The only validated treatment for the vertigo attacks is chemical labyrinthectomy by intra-tympanic injections of the ototoxic antibiotic gentamicin for which two double-blind, placebo-controlled trials found a significant effect. Treatment with gentamicin is ablative, i.e. the goal of the treatment is to destroy the vestibular sensors of the affected ear. This carries a risk of long-standing unsteadiness alongside with permanent hearing loss in the treated ear. Still, no treatments seem to protect from the hearing loss associated with Menière's disease.

The first to advocate the use of transmyringeal ventilation tubes for Menière's disease was Tumarkin in 1966. Tumarkin et al. suggested that negative middle-ear pressure, due to poor tubal function, would lead to a relative over-pressure in the inner ear and that this might be one of the mechanisms behind Menière's disease. In addition, Tumarkin et al. presented several cases where treatment with transmyringeal tubes resulted in relief from vertigo attacks. Hall and Brackmann performed tympanometry in patients with Menière's disease and showed that some, but not all, patients had negative middle-ear pressure and they questioned Tumarkin's suggestions.

Enrollment: 104 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients with definite or probable unilateral Menière's disease according to the diagnostic criteria formulated by the Classification Committee of the Bárány Society, The Japan Society for Equilibrium Research, the European Academy of Otology and Neurotology (EAONO), the Equilibrium Committee of the American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS), and the Korean Balance Society:

• Two or more spontaneous episodes of vertigo, each lasting 20 minutes to 12 hours
• Audiometrically documented low- to medium-frequency sensorineural hearing loss in the affected ear on at least one occasion before, during or after one of the episodes of vertigo
• Fluctuating aural symptoms (hearing, tinnitus or fullness) in the affected ear
• Not better accounted for by another vestibular diagnosis

Exclusion criteria

• Bilateral Menière's disease
• Additional neurotological disorders (e.g. vestibular migraine, vertebrobasilar transient ischemic attack or acoustic neuroma)
• Previous surgical therapy such as intratympanic gentamicin or endolymphatic sac surgery
• Expected problems to adhere to the study protocol (dementia, non-fluent in Danish, substance abuse, etc.)
• Previous treatment with transmyringeal ventilation tubes after childhood
• A serious illness that might interfere with treatment or follow-up

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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104 participants in 2 patient groups

Ventilation tube insertion

Experimental group

Description:

Ventilation tube insertion into the tympanic membrane.

Treatment:

Procedure: Transmyringeal ventilation tube insertion

Sham-treatment

Sham Comparator group

Description:

Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion.

Treatment:

Procedure: Sham-treatment