Yonsei University Wonju Severance Christian Hospital
Wŏnju, Gangwon-do, 26426, South Korea
Location status: Recruiting
Location contact
Tae Hoon Kong, MD, PhD
CONTACT
Tae Hoon Kong, MD, PhD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT05474963
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
SSNHL(Sudden Sensory Neural Hearing Loss)
Ear Diseases
Hearing Disorders
Hearing Loss
Hearing Loss, Idiopathic Sudden Sensorineural
Hearing Loss, Sudden
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Pathological Conditions, Signs and Symptoms
Sensation Disorders
Signs and Symptoms
Sudden Hearing Loss
Age range
20 year–100 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
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 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.
Secondary outcomes
-
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)
Other outcomes
-
Internal Acoustic canal MRI
Time frame: MRI
The baseline studies of internal acoustic canal MRI results of SSNHL patients.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Wonju Severance Christian Hospital
Other
Registry information
Official study title
Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
Important dates
- Study start
- 2021
- Primary completion
- 2031
- Study completion
- 2035
- First posted
- Jul 26, 2022
- Registry last updated
- Mar 26, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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