Clinical trial NCT05474963: Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
Official title: Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: Hearing outcome 1 week - PTA
timeFrame: 1 week PTA
measure: Hearing outcome 3 weeks - PTA
timeFrame: 3 weeks PTA
measure: Hearing outcome 2 months - PTA
timeFrame: 2 month PTA
measure: Hearing outcome 3 months - PTA
timeFrame: 3 month PTA
measure: Hearing outcome 6 months - PTA
timeFrame: 6 months PTA
Secondary outcomes:
measure: Electrolytes and chemistries after high dose steroid therapy
timeFrame: 5 days electrolytes and chemistries
Other outcomes:
measure: Internal Acoustic canal MRI
timeFrame: MRI
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
state: Gangwon
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.