Status:
UNKNOWN
Ventilation Tube Insertion for Unilateral Menière's Disease
Lead Sponsor:
Casper Grønlund Larsen
Conditions:
Meniere Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT04835688
Start Date
September 20 2021
End Date
January 1 2024
Last Update
October 14 2021
Active Locations (1)
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1
Zealand University Hospital
Køge, Denmark, 4600