Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

March 23, 2025 updated by: Tae Hoon Kong, MD, PhD, Wonju Severance Christian Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gangwon
      • Wŏnju, Gangwon, Korea, Republic of, 26426
        • Recruiting
        • Yonsei University Wonju Severance Christian Hospital
        • Contact:
        • Principal Investigator:
          • Tae Hoon Kong, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Among the adults over 20yrs of age, diagnosed sudden sensorineural hearing loss at Wonju Severance Christian Hospital, Department of otolaryngology.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
SSNHL treated with WSCH protocol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hearing outcome 1 week - PTA
Time Frame: 1 week PTA
Hearing change status near 1 weak after treatment start measured by pure tone audiometry1
1 week PTA
Hearing outcome 3 weeks - PTA
Time Frame: 3 weeks PTA
Hearing change status near 3 weaks after treatment start measured by pure tone audiometry
3 weeks PTA
Hearing outcome 2 months - PTA
Time Frame: 2 month PTA
Hearing change status near 3 weaks after treatment start measured by pure tone audiometry
2 month PTA
Hearing outcome 3 months - PTA
Time Frame: 3 month PTA
Hearing change status near 3 months after treatment start measured by pure tone audiometry
3 month PTA
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.
6 months PTA

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrolytes and chemistries after high dose steroid therapy
Time Frame: 5 days electrolytes and chemistries

The results of blood tests of electrolytes and chemistries at 5 days after treatment start.

(Na, K, Cl, CO2, BUN, Cr, Glucose, Amylase, Total protein, Albumin, AST, ALT, ALP, r-GT, Total Bilirubin)
5 days electrolytes and chemistries

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Internal Acoustic canal MRI
Time Frame: MRI
The baseline studies of internal acoustic canal MRI results of SSNHL patients.
MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wonju Severance Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2021

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2035

Study Registration Dates

First Submitted

June 6, 2022

First Submitted That Met QC Criteria

July 24, 2022

First Posted (Actual)

July 26, 2022

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 23, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WSCH-ENT-SSNHL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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