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Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

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ClinicalTrials.gov Identifier: NCT05474963
Recruitment Status : Recruiting
First Posted : July 26, 2022
Last Update Posted : July 26, 2022
Sponsor:
Information provided by (Responsible Party):
Tae Hoon Kong, MD, PhD, Wonju Severance Christian Hospital

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.

Condition or disease
Hearing Loss, Sudden Hearing Loss, Sensorineural Hearing Loss, Cochlear Hearing Loss Hearing Loss, Central

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
Actual Study Start Date : July 14, 2021
Estimated Primary Completion Date : December 31, 2031
Estimated Study Completion Date : December 31, 2035





Primary Outcome Measures :
  1. Hearing outcome 1 week - PTA [ Time Frame: 1 week PTA ]
    Hearing change status near 1 weak after treatment start measured by pure tone audiometry1

  2. 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. Hearing outcome 2 months - PTA [ Time Frame: 2 month PTA ]
    Hearing change status near 3 weaks after treatment start measured by pure tone audiometry

  4. Hearing outcome 3 months - PTA [ Time Frame: 3 month PTA ]
    Hearing change status near 3 months after treatment start measured by pure tone audiometry

  5. 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 Outcome Measures :
  1. 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 Outcome Measures:
  1. Internal Acoustic canal MRI [ Time Frame: MRI ]
    The baseline studies of internal acoustic canal MRI results of SSNHL patients.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05474963


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

Locations
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Korea, Republic of
Yonsei University Wonju Severance Christian Hospital Recruiting
Wŏnju, Gangwon, Korea, Republic of, 26426
Contact: Tae Hoon Kong, MD, PhD    +821044650635    cochlear84@yonsei.ac.kr   
Principal Investigator: Tae Hoon Kong, MD, PhD         
Sponsors and Collaborators
Wonju Severance Christian Hospital
Publications:
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Responsible Party: Tae Hoon Kong, MD, PhD, Clinical Assistant Professor, Wonju Severance Christian Hospital
ClinicalTrials.gov Identifier: NCT05474963    
Other Study ID Numbers: WSCH-ENT-SSNHL-01
First Posted: July 26, 2022    Key Record Dates
Last Update Posted: July 26, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tae Hoon Kong, MD, PhD, Wonju Severance Christian Hospital:
Hearing Loss
Hearing Loss, sudden
Additional relevant MeSH terms:
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Hearing Loss
Deafness
Hearing Loss, Sensorineural
Hearing Loss, Sudden
Hearing Loss, Central
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Auditory Diseases, Central
Retrocochlear Diseases
Brain Diseases
Central Nervous System Diseases