Ventilation Tube Insertion for Unilateral Menière's Disease
Meniere Disease
About this trial
This is an interventional treatment trial for Meniere Disease focused on measuring Ventilation tube insertion, Grommet insertion, Vertigo
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
Sites / Locations
- Zealand University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Sham Comparator
Ventilation tube insertion
Sham-treatment
Ventilation tube insertion into the tympanic membrane.
Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion.