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RecruitingNCT05474963Updated Mar 26, 2025

Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

An observational study in SSNHL(Sudden Sensory Neural Hearing Loss), Sudden Hearing Loss and Hearing Loss, Idiopathic Sudden Sensorineural, sponsored by Wonju Severance Christian Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-03-26.

Sponsored by Wonju Severance Christian Hospital · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
20 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • SSNHL(Sudden Sensory Neural Hearing Loss)
  • Sudden Hearing Loss
  • Hearing Loss, Idiopathic Sudden Sensorineural
  • Hearing Loss, Sudden

Keywords

  • Hearing Loss
  • Hearing Loss, sudden
  • SSNHL
  • Sudden sensorineural hearing loss
  • sudden sensory neural hearing loss
03

In context

Hearing Loss, Sudden

66 studies on the registry are indexed under Hearing Loss, Sudden; 25 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 82 across 14 observational studies indexed under Hearing Loss, Sudden.

Browse Hearing Loss, Sudden studies →

Lead sponsor

Wonju Severance Christian Hospital is the lead sponsor of 43 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • SSNHL treated with WSCH protocol

    SSNHL treated with WSCH protocol

06

What researchers measure

Primary outcomes

  1. Hearing outcome 1 week - PTA

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

    Time frame: 1 week PTA

  2. Hearing outcome 3 weeks - PTA

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

    Time frame: 3 weeks PTA

  3. Hearing outcome 2 months - PTA

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

    Time frame: 2 month PTA

  4. Hearing outcome 3 months - PTA

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

    Time frame: 3 month PTA

  5. Hearing outcome 6 months - PTA

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

    Time frame: 6 months PTA

Secondary outcomes

  1. Electrolytes and chemistries after high dose steroid therapy

    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)

    Time frame: 5 days electrolytes and chemistries

Other outcomes

  1. Internal Acoustic canal MRI

    The baseline studies of internal acoustic canal MRI results of SSNHL patients.

    Time frame: MRI

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 31369359 ↗
  • Moon 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. PubMed 19283405 ↗
  • Moon 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. PubMed 22089956 ↗
  • Rhee 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. PubMed 30267033 ↗
  • Park 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. PubMed 27459199 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2021 (actual). Primary completion is estimated for Dec 2031, 125 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 6, 2022
First posted
Jul 26, 2022
StartActual
Jul 14, 2021
Primary completionEst.
Dec 31, 2031
CompletionEst.
Dec 31, 2035
Last update
Mar 26, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 26, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05474963
Lead sponsor
Wonju Severance Christian Hospital
Responsible party
Tae Hoon Kong, MD, PhD (Assistant Professor, Wonju Severance Christian Hospital) — Principal investigator
First posted
Jul 26, 2022
Start date
Jul 14, 2021
Primary completion
Dec 31, 2031 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Mar 26, 2025

Study contacts

Tae Hoon Kong, MD, PhD
Contact
cochlear84@yonsei.ac.kr
+821044650635

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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