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Clinical Trials/NCT05474963
NCT05474963
Recruiting
Not Applicable

Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

Wonju Severance Christian Hospital1 site in 1 country1,000 target enrollmentJuly 14, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Wonju Severance Christian Hospital
Enrollment
1000
Locations
1
Primary Endpoint
Hearing outcome 1 week - PTA
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

This study is to build a cohort of sudden sensorineural hearing loss (SSNHL) patients. When the patient visited the Department of otolaryngology clinic for hearing loss, we can diagnose the SSNHL following the result of pure tone audiometry and the history of the patient. The cohort is a system that tracks the hearing recovery status, timing, and degree of recovery of patients who received cocktail therapy with or without high-dose steroids, vasodilators, antiviral agents, and intratympanic steroid injections, satellite ganglion block, and hyperbaric oxygen therapy.

Registry
clinicaltrials.gov
Start Date
July 14, 2021
End Date
December 31, 2035
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Wonju Severance Christian Hospital
Responsible Party
Principal Investigator
Principal Investigator

Tae Hoon Kong, MD, PhD

Assistant Professor

Wonju Severance Christian Hospital

Eligibility Criteria

Inclusion Criteria

  • Adult patients over 20 years of age
  • A patient who visited Wonju Severance Christian Hospital, Department of Otolaryngology and was diagnosed with sudden hearing loss as it was confirmed that hearing loss of 30dBHL or more occurred within 3 days at three consecutive frequencies in a pure tone audiometry test.
  • Those who have fully explained the purpose and content of the study and voluntarily agreed to the written consent

Exclusion Criteria

  • If the patients do not want to or do not fill out the consent form
  • If treatment is started for sudden hearing loss, but the possibility of other inner ear diseases including Meniere's disease is suspected due to repeated hearing loss, repeated recovery, dizziness, tinnitus, etc.
  • Other cases where it is judged difficult to carry out the clinical trial due to the judgment of the person in charge of the above clinical trial

Outcomes

Primary Outcomes

Hearing outcome 1 week - PTA

Time Frame: 1 week PTA

Hearing change status near 1 weak after treatment start measured by pure tone audiometry1

Hearing outcome 3 weeks - PTA

Time Frame: 3 weeks PTA

Hearing change status near 3 weaks after treatment start measured by pure tone audiometry

Hearing outcome 3 months - PTA

Time Frame: 3 month PTA

Hearing change status near 3 months after treatment start measured by pure tone audiometry

Hearing outcome 6 months - PTA

Time Frame: 6 months PTA

Hearing change status near 6 months after treatment start measured by pure tone audiometry, which is final.

Hearing outcome 2 months - PTA

Time Frame: 2 month PTA

Hearing change status near 3 weaks after treatment start measured by pure tone audiometry

Secondary Outcomes

  • Electrolytes and chemistries after high dose steroid therapy(5 days electrolytes and chemistries)

Study Sites (1)

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