None listed
Conditions
Interventions
Medical Device, Procedure/Surgery :
Among patients with suspected perilymph fistula, those who meet the selection criteria, do not meet the exclusion criteria, and agree to participate in the study
Sponsors
Soonchunhyang University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Adults aged 19 and older ? Those who have symptoms of sensorineural hearing loss accompanied by dizziness within 3 months after barotrauma ? Normal eardrum findings ? Spontaneous nystagmus/positional nystagmus or positive fistula test ? Subjects who have given written consent in the consent form
Exclusion criteria
Exclusion criteria: ? Those with posterior labyrinth lesions or central lesions ? Chronic otitis media, recurrent otitis media, tympanic membrane perforation, acute inflammatory disease, conductive and sudden sensetive those diagnosed with and receiving treatment for hearing loss, objective tinnitus, or somatic tinnitus ? Antidepressants for neuropsychiatric diseases such as depression, anxiety, sleep disorders, and convulsive disorders. People taking drugs that affect the neuropsychiatric system, such as anti-anxiety drugs ? Those who have received drugs (steroids including oral/injected drugs, ototoxic drugs, etc.), surgery, or rehabilitation treatment that may affect hearing and dizziness function within 4 weeks prior to screening ? Those in whom external ear canal surgery is not possible due to abnormal structure of the external auditory canal ? Those who participated in another clinical (human application) test within 4 weeks prior to participating in this human application test ? If the person does not want to, does not fill out the consent form, or is unable to understand the contents of the consent form (illiterate, foreigner, etc.) ? In addition to the above matters, subjects who are judged by the clinical trial director to be unable to comply with the test requirements or who are deemed unsuitable by other doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is a comparison of the fistula confirmation rate (fistula diagnosis rate) of perilymph fluid outflow under a microscope and under an endoscope. | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Degree of improvement in pure tone hearing test 1 month after surgery compared to before surgery;(2) Degree of improvement in dizziness (DHI, NPRS) 1 month after surgery compared to before surgery;(3) Nystagmus disappearance rate 1 month after surgery compared to before surgery;(4) Microscope Concordance rate between fistula confirmation and endoscopic fistula confirmation;(5) Comparison of results between microscopic-only fistula confirmation and microscopic and endoscopic fistula confirmation groups;(6) Comparison of fistula confirmation rates between groups A and B | — |
Countries
Korea, Republic of
Contacts
Public ContactYunkyung Yim
Yonsei University Health System, Severance Hospital
Outcome results
None listed