Clinical trial: Ventilation Tube Insertion for Unilateral Menière's Disease (NCT04835688)

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

          -  Persons being treated with ototoxic medication (treatment of infections,
             cancer-treatment etc.)

          -  A serious illness that might interfere with treatment or follow-up
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old woman comes to the clinic complaining of dizziness.  She also has occasional nausea and ringing in her right ear.  The patient also has difficulty hearing while holding her phone to the left ear, although hearing in her right ear is normal.  The dizziness improves spontaneously, and she feels fine between episodes.  Past medical history is notable for hypothyroidism and low vit D level, for which she is using Levothyroxine and Vit D pearl.  She does not use tobacco or drink alcohol. Physical examination shows sensorineural hearing loss in the left ear. She has only one-man sexual partner and menopaused 2 years ago.

Patient description (patient's own words): The other day, I had to go to the clinic due to severe dizziness. I'm 47 years old, and I've been suffering from nausea and ringing in my right ear. I also have difficulty hearing in my left ear while I hold my phone, even if my hearing in my right ear is normal. The dizziness just gets me all of a sudden but I don't have any symptoms in between 2 episodes. I suffer from hypothyroidism and low vitamin D levels. So I take Levothyrox and vitamin D pearl. I don't smoke or drink. They conducted a physical exam and said I had hearing loss in my left ear. My only partner is my husband, and I'm menopause for 2 years now.

Does the patient match the trial criteria? 1