Clinical trial: Vestibular Prognosis Assessment of ISSNHL With Vestibular Dysfunction Treated With Oral or Intratympanic Glucocorticoids (NCT03974867)

Eligibility criteria:
Inclusion Criteria:

          1. Adults aged between 18 to 70 years old;

          2. Diagnosed with unilateral ISSNHL according to the National Institute for Deafness and
             Communication Disorders (NICDC) criteria30: a decrease in hearing of ≥30 decibels
             (dB), affecting at least 3 consecutive frequencies occurring within a 72-hour period.
             Since premorbid audiometry is generally unavailable, premorbid hearing level will be
             defined as the opposite ear's thresholds in this condition;

          3. Reported vertigo/dizziness/imbalance/lateropulsion and abnormal results in at least
             one of the vestibular function tests (including SOT, caloric test, vHIT, cVEMP, and
             oVEMP);

          4. Onset of audio-vestibular symptoms occurred within 7 days;

          5. Be willing to sign the informed consent of the study.

        Exclusion Criteria:

          1. Definite etiologies are found or highly suspected after clinical evaluations, such as
             vestibular schwannoma, stroke, trauma or demyelinating disease;

          2. Diagnosed with a present or previous hearing or balance disorders which might be
             confused with ISSNHL (history of Meniere's disease, benign paroxysmal positional
             vertigo, vestibular neuronitis or vestibular migraine; history of otosclerosis;
             history of luetic, congenital or genetic hearing loss, etc.);

          3. Hearing level (evaluated with PTA) in the unaffected ear is abnormal, so that a
             premorbid hearing level of the affected ear may not be estimated;

          4. Suspected as central vestibular dysfunction, evaluated by present and previous medical
             history, physical examination and VNG;

          5. Present with conditions contraindicated systemic glucocorticoids use, such as
             tuberculosis, hepatitis C or B infection, active herpes zoster infection or other
             known human immunodeficiency virus, pancreatitis, insulin-dependent diabetes mellitus,
             severe osteoporosis, chronic renal insufficiency or gastrointestinal ulcer;

          6. A history of more than 3 days sufficient systemic glucocorticoids uses (≥1 mg/kg/d)
             within 3 months which may increase the risk of adverse effects. Considering that the
             glucocorticoids is a well-acknowledged standard treatment and that the patients might
             have probably received initial systemic glucocorticoids in emergency before outpatient
             appointment, we only excluded those who have received sufficient glucocorticoids
             (≥1mg/kg/d prednisone) for more than 3 days in previous 3 months;

          7. Having received other systemic etiological treatments for ISSNHL (including hyperbaric
             oxcygen therapy (HBOT), thrombolytic drugs and antiviral drugs) which may confound the
             effects of study drugs. Patients who received only emergency or symptomatic treatments
             will not be excluded (i.e., betahistine, promethazine, diazepam, mecobalamin or ginkgo
             biloba leaves extracts);

          8. Not appropriate for receiving vestibular function tests due to combination of
             fracture, inflammatory or suppurative ear disease, severe cervical spondylosis or
             severe psychotic disorders;

          9. Multiple organ dysfunction or unstable vital signs;

         10. Pregnancy or lactation;

         11. Evaluated as unsuitable for the trial for any other reasons by investigators.
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.
Subject must be at most 70 Years

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? Entailment