Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

Hearing Loss Clinical Trial

Official title:

Prospective Cohort Study of Sudden Sensorineural Hearing Loss in Wonju Severance Christian Hospital

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05474963
• Other study ID #: WSCH-ENT-SSNHL-01
• Status: Recruiting
• Start date: July 14, 2021
• Est. completion date: December 31, 2035

Study information

• Verified date: August 2023
• Source: Wonju Severance Christian Hospital
• Contact: Tae Hoon Kong, MD, PhD
• Phone: +821044650635
• Email: cochlear84[@]yonsei.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2035
• Est. primary completion date: December 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Loss
• Hearing Loss, Central
• Hearing Loss, Cochlear
• Hearing Loss, Sensorineural
• Hearing Loss, Sudden

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Wonju Severance Christian Hospital	Wonju	Gangwon

Sponsors (1)

Lead Sponsor	Collaborator
Wonju Severance Christian Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Internal Acoustic canal MRI	The baseline studies of internal acoustic canal MRI results of SSNHL patients.	MRI
Primary	Hearing outcome 1 week - PTA	Hearing change status near 1 weak after treatment start measured by pure tone audiometry1	1 week PTA
Primary	Hearing outcome 3 weeks - PTA	Hearing change status near 3 weaks after treatment start measured by pure tone audiometry	3 weeks PTA
Primary	Hearing outcome 2 months - PTA	Hearing change status near 3 weaks after treatment start measured by pure tone audiometry	2 month PTA
Primary	Hearing outcome 3 months - PTA	Hearing change status near 3 months after treatment start measured by pure tone audiometry	3 month PTA
Primary	Hearing outcome 6 months - PTA	Hearing change status near 6 months after treatment start measured by pure tone audiometry, which is final.	6 months PTA
Secondary	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)	5 days electrolytes and chemistries