Clinical trial NCT04835688: Ventilation Tube Insertion for Unilateral Menière's Disease
Official title: Transmyringeal Ventilation Tube Insertion for Unilateral Menière's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Meniere Disease
Keywords: Ventilation tube insertion
Grommet insertion
Vertigo
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pro-spective, double-blinded, sham-controlled, randomized, clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of vertigo attacks lasting more than 20 minutes
timeFrame: 3 months
measure: Number of vertigo attacks lasting more than 20 minutes
timeFrame: 24 months
Secondary outcomes:
measure: Pure-tone audiometry
timeFrame: 3 months
measure: AAO-HNS Functional Level Scale
timeFrame: 3 months
measure: Hearing, tinnitus, unsteadiness and aural fullness
timeFrame: 24 months
measure: Number of subjects leaving
timeFrame: 24 months
measure: Number of subjects satisfied
timeFrame: 24 months
measure: Speech audiometry
timeFrame: 3 months
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Zealand University Hospital
name: Casper Grønlund Larsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Larsen CG, Karlberg M, Guldfred F, Devantier L, Maagaard M, Homoe P, Djurhuus BD. Transmyringeal ventilation tube insertion for unilateral Meniere's disease: a protocol for a prospective, sham-controlled, double-blinded, randomized, clinical trial. Trials. 2022 Oct 17;23(1):877. doi: 10.1186/s13063-022-06777-w.