Ventilation Tube Insertion for Unilateral Menière's Disease

NCT04835688 | Unknown DMC

• 1 other identifier: CG1-2021
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Meniere Disease

Keywords

Ventilation tube insertion; Grommet insertion; Vertigo

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Pure-tone audiometry

  3 months

• AAO-HNS Functional Level Scale

  3 months

• Hearing, tinnitus, unsteadiness and aural fullness

  24 months

• Number of subjects leaving

  24 months

• Number of subjects satisfied

  24 months

Study Arms (2)

Ventilation tube insertion

EXPERIMENTAL

Ventilation tube insertion into the tympanic membrane.

Procedure: Transmyringeal ventilation tube insertion

Sham-treatment

SHAM COMPARATOR

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

Procedure: Sham-treatment

Interventions

Transmyringeal ventilation tube insertion 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.

Also known as: Ventilation tube insertion, grommet insertion

Ventilation tube insertion

Sham-treatment 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.

Sham-treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Casper Grønlund Larsen: lead

Study Sites (1)

Zealand University Hospital

Køge, 4600, Denmark

RECRUITING

Related Publications (1)

• 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.

  PMID: 36253829 DERIVED

MeSH Terms

Conditions

Meniere Disease; Vertigo

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Vestibular Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Study Officials

• Casper Grønlund Larsen, MD

  Zealand University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Casper Grønlund Larsen, MD

CONTACT

47 32 38 00; caslar@regionsjaelland.dk

Bjarki Djurhuus, MD, PhD

CONTACT

bjdd@regionsjaelland.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, data collectors, outcome assessors, research personnel, and data analysts will be blinded to treatment allocation. However, the ENT-specialist performing the insertion of the ventilation tube or placebo-treatment will inevitably be aware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD-student

Model Details: A pro-spective, double-blinded, sham-controlled, randomized, clinical trial

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: September 20, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1/6-2024.
• Access Criteria: Individual patient data will be shared upon reasonable request.

Locations

DK (1)