Ventilation Tube Insertion for Unilateral Menière's Disease

Transmyringeal Ventilation Tube Insertion for Unilateral Menière's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Meniere Disease
• Intervention / Treatment: Procedure: Transmyringeal ventilation tube insertion; Procedure: Sham-treatment

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.

• Study Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Casper Grønlund Larsen, MD; Phone Number: 47 32 38 00; Email: caslar@regionsjaelland.dk
• Study Contact Backup: Name: Bjarki Djurhuus, MD, PhD; Email: bjdd@regionsjaelland.dk

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Recruiting
    • Zealand University Hospital
    • Contact: Casper Grønlund Larsen, MD; Phone Number: 47323800; Email: caslar@regionsjaelland.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ventilation tube insertion; Ventilation tube insertion into the tympanic membrane.	Procedure: Transmyringeal ventilation tube insertion; In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon. For the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted.; Other Names: Ventilation tube insertion, grommet insertion
Sham Comparator: Sham-treatment; Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion.	Procedure: Sham-treatment; For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of vertigo attacks lasting more than 20 minutes	Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.	3 months
Number of vertigo attacks lasting more than 20 minutes	Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pure-tone audiometry	4 tone average of 500, 1000, 2000, and 3000 Hz (dB) and 3 tone average of 125, 250, and 500 Hz (dB).	3 months
AAO-HNS Functional Level Scale	Questionnaire with written descriptions of how Menière's disease affects the life of the patient, from no impact at all to totally handicapped and unable to work.	3 months
Hearing, tinnitus, unsteadiness and aural fullness	Patient-reported outcome by filling out a self-evaluation of symptoms-questionnaire.	24 months
Number of subjects leaving	To check for unsatisfied treatment.	24 months
Number of subjects satisfied	To check for satisfied treatment	24 months
Speech audiometry	Discrimination in %.	3 months

Collaborators and Investigators

• Sponsor: Casper Grønlund Larsen
• Investigators: Principal Investigator: Casper Grønlund Larsen, MD, Zealand University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: April 6, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 5, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Vertigo; Ventilation tube insertion; Grommet insertion
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Endolymphatic Hydrops; Meniere Disease
• Other Study ID Numbers: CG1-2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Individual patient data will be shared upon reasonable request
• IPD Sharing Time Frame: 1/6-2024.
• IPD Sharing Access Criteria: Individual patient data will be shared upon reasonable request.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No