Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 14, 2021
CompletedFirst Submitted
Initial submission to the registry
June 6, 2022
CompletedFirst Posted
Study publicly available on registry
July 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2035
March 26, 2025
March 1, 2025
10.5 years
June 6, 2022
March 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Hearing outcome 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
Hearing change status near 3 weaks after treatment start measured by pure tone audiometry
3 weeks PTA
Hearing outcome 2 months - PTA
Hearing change status near 3 weaks after treatment start measured by pure tone audiometry
2 month PTA
Hearing outcome 3 months - PTA
Hearing change status near 3 months after treatment start measured by pure tone audiometry
3 month PTA
Hearing outcome 6 months - PTA
Hearing change status near 6 months after treatment start measured by pure tone audiometry, which is final.
6 months PTA
Secondary Outcomes (1)
Electrolytes and chemistries after high dose steroid therapy
5 days electrolytes and chemistries
Other Outcomes (1)
Internal Acoustic canal MRI
MRI
Study Arms (1)
SSNHL treated with WSCH protocol
SSNHL treated with WSCH protocol
Eligibility Criteria
Among the adults over 20yrs of age, diagnosed sudden sensorineural hearing loss at Wonju Severance Christian Hospital, Department of otolaryngology.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Related Publications (5)
Chandrasekhar SS, Tsai Do BS, Schwartz SR, Bontempo LJ, Faucett EA, Finestone SA, Hollingsworth DB, Kelley DM, Kmucha ST, Moonis G, Poling GL, Roberts JK, Stachler RJ, Zeitler DM, Corrigan MD, Nnacheta LC, Satterfield L. Clinical Practice Guideline: Sudden Hearing Loss (Update). Otolaryngol Head Neck Surg. 2019 Aug;161(1_suppl):S1-S45. doi: 10.1177/0194599819859885.
PMID: 31369359BACKGROUNDMoon IS, Kim J, Lee SY, Choi HS, Lee WS. How long should the sudden hearing loss patients be followed after early steroid combination therapy? Eur Arch Otorhinolaryngol. 2009 Sep;266(9):1391-5. doi: 10.1007/s00405-009-0932-9. Epub 2009 Mar 13.
PMID: 19283405BACKGROUNDMoon IS, Lee JD, Kim J, Hong SJ, Lee WS. Intratympanic dexamethasone is an effective method as a salvage treatment in refractory sudden hearing loss. Otol Neurotol. 2011 Dec;32(9):1432-6. doi: 10.1097/MAO.0b013e318238fc43.
PMID: 22089956BACKGROUNDRhee TM, Hwang D, Lee JS, Park J, Lee JM. Addition of Hyperbaric Oxygen Therapy vs Medical Therapy Alone for Idiopathic Sudden Sensorineural Hearing Loss: A Systematic Review and Meta-analysis. JAMA Otolaryngol Head Neck Surg. 2018 Dec 1;144(12):1153-1161. doi: 10.1001/jamaoto.2018.2133.
PMID: 30267033BACKGROUNDPark SM, Han C, Lee JW, Kong TH, Seo YJ. Does Herpes Virus Reactivation Affect Prognosis in Idiopathic Sudden Sensorineural Hearing Loss? Clin Exp Otorhinolaryngol. 2017 Mar;10(1):66-70. doi: 10.21053/ceo.2016.00360. Epub 2016 Jul 27.
PMID: 27459199BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 6, 2022
First Posted
July 26, 2022
Study Start
July 14, 2021
Primary Completion (Estimated)
December 31, 2031
Study Completion (Estimated)
December 31, 2035
Last Updated
March 26, 2025
Record last verified: 2025-03