SSNHL(Sudden Sensory Neural Hearing Loss)NCT05474963
Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
An observational study of SSNHL(Sudden Sensory Neural Hearing Loss) and Sudden Hearing Loss, run by Wonju Severance Christian Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 100 years
- Conditions the study is for
- SSNHL(Sudden Sensory Neural Hearing Loss), Sudden Hearing Loss, Hearing Loss, Idiopathic Sudden Sensorineural
- How many people
- 1,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 14 Jul 2021to 31 Dec 2035
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Among the adults over 20yrs of age, diagnosed sudden sensorineural hearing loss at Wonju Severance Christian Hospital, Department of otolaryngology.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426
Tae Hoon Kong, MD, PhD, +821044650635, cochlear84@yonsei.ac.kr
Tae Hoon Kong, MD, PhD
About this study
Official title: 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.
- Conditions
- 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
- Medical subject headings
- Hearing Loss, Sudden, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SSNHL treated with WSCH protocol | SSNHL treated with WSCH protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing outcome 1 week - PTA
Hearing change status near 1 weak after treatment start measured by pure tone audiometry1
Measured: 1 week PTA
Hearing outcome 3 weeks - PTA
Hearing change status near 3 weaks after treatment start measured by pure tone audiometry
Measured: 3 weeks PTA
Hearing outcome 2 months - PTA
Hearing change status near 3 weaks after treatment start measured by pure tone audiometry
Measured: 2 month PTA
Hearing outcome 3 months - PTA
Hearing change status near 3 months after treatment start measured by pure tone audiometry
Measured: 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.
Measured: 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)
Measured: 5 days electrolytes and chemistries
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start14 Jul 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SSNHL(Sudden Sensory Neural Hearing Loss)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tae Hoon Kong, MD, PhD, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474963
- Sponsor's protocol ID
- WSCH-ENT-SSNHL-01
- Status last verified
- Mar 2025
- First submitted
- 6 Jun 2022
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 31369359Moon 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 19283405Moon 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 22089956Rhee 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 30267033Park 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
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
- ClinicalTrials.gov ID
- NCT05474963
- Acronym / sponsor ID
- WSCH-ENT-SSNHL-01
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SSNHL treated with WSCH protocol | – | –SSNHL treated with WSCH protocol |
Who may qualify
- Ages
- 20 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Among the adults over 20yrs of age, diagnosed sudden sensorineural hearing loss at Wonju Severance Christian Hospital, Department of otolaryngology.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 2 months - PTA
Time frame: 2 month 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.
1 secondary outcome
Electrolytes and chemistries after high dose steroid therapy
Time frame: 5 days electrolytes and chemistries
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Background: PubMed 31369359Chandrasekhar 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.
- Background: PubMed 19283405Moon 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.
- Background: PubMed 22089956Moon 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.
- Background: PubMed 30267033Rhee 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.
- Background: PubMed 27459199Park 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SSNHL(Sudden Sensory Neural Hearing Loss) and Sudden Hearing Loss, run by Wonju Severance Christian Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tae Hoon Kong, MD, PhD (+821044650635, cochlear84@yonsei.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing outcome 1 week - PTA (time frame: 1 week PTA). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05474963, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.