Ventilation Tube Insertion for Unilateral Menière's Disease

NCT ID: NCT04835688

Last Updated: 2021-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-20
• Study Completion Date: 2024-01-01

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.

Conditions

Meniere Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Ventilation tube insertion

Ventilation tube insertion into the tympanic membrane.

Group Type: EXPERIMENTAL

Transmyringeal ventilation tube insertion

Intervention Type: PROCEDURE

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.

Sham-treatment

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

Group Type: SHAM_COMPARATOR

Sham-treatment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Ventilation tube insertion, grommet insertion

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Casper Grønlund Larsen

OTHER

Sponsor Role: lead

Responsible Party

Casper Grønlund Larsen

MD, PhD-student

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Casper Grønlund Larsen, MD

Role: PRINCIPAL_INVESTIGATOR

Zealand University Hospital

Locations

Zealand University Hospital

Køge, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Casper Grønlund Larsen, MD

Role: CONTACT

caslar@regionsjaelland.dk

47 32 38 00

Bjarki Djurhuus, MD, PhD

Role: CONTACT

bjdd@regionsjaelland.dk

Facility Contacts

Casper Grønlund Larsen, MD

Role: primary

caslar@regionsjaelland.dk

47323800

References

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.

Reference Type: DERIVED

PMID: 36253829 (View on PubMed)

Other Identifiers

CG1-2021

Identifier Type: -

Identifier Source: org_study_id