Status Approved
First Submitted Date
2020/03/20
Registered Date
2020/03/27
Last Updated Date
2020/03/26
CRIS Required
WHO ICTRP (International Clinical Trial Registry Platform) Required
1. Background
CRIS Registration Number |
KCT0004863 |
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Unique Protocol ID | knuh2018-07-013 |
Public/Brief Title | The efficacy of alpha-lipoic acid on hearing results and tinnitus in idiopathic sudden sensorineural hearing loss |
Scientific Title | The efficacy of alpha-lipoic acid on hearing results and tinnitus in idiopathic sudden sensorineural hearing loss and noise-induced hearing loss, prospective study |
Acronym | |
MFDS Regulated Study | Yes |
IND/IDE Protocol | |
Registered at Other Registry | No |
Healthcare Benefit Approval Status | Not applicable |
2. Institutional Review Board / Ethics Committee
Board Approval Status | Submitted approval |
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Board Approval Number | knuh 2018-07-013 |
Approval Date | 2018-12-10 |
Institutional Review Board Name | Institutional review board of kyungpook national university |
Institutional Review Board Address | 130, Dongdeok-ro, Jung-gu, Daegu |
Institutional Review Board Telephone | 053-200-5430 |
Data Monitoring Committee |
3. Contact Details
Contact Person for Principal Investigator / Scientific Queries | |
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Name | Kyu-yup Lee |
Title | professor |
Telephone | +82-53-420-5785 |
Affiliation | Kyungpook National University Hospital |
Address | 130, Dongdeok-ro(Samduck-Dong 2ga), Jung-Gu, Daegu, 41944, Korea. |
Contact Person for Public Queries | |
Name | da jung Jung |
Title | clinical professor |
Telephone | +82-53-420-5777 |
Affiliation | Kyungpook National University Hospital |
Address | 130, Dongdeok-ro(Samduck-Dong 2ga), Jung-Gu, Daegu, 41944, Korea. |
Contact Person for Updating Information | |
Name | kyu-yup Lee |
Title | professor |
Telephone | +82-53-420-5785 |
Affiliation | Kyungpook National University Hospital |
Address | 130, Dongdeok-ro(Samduck-Dong 2ga), Jung-Gu, Daegu, 41944, Korea. |
4. Status
Study Site | Single | |
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Overall Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-03-27 Anticipated | |
Target Number of Participant | 100 | |
Primary Completion Date | ||
Study Completion Date | ||
Recruitment Status by Participating Study Site 1 | ||
Name of Study | Kyungpook National University Hospital | |
Recruitment Status | Recruiting | |
Date of First Enrollment | 2020-03-27 , |
5. Source of Monetary / Material Support
1. Source of Monetary/Material Support | |
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Organization Name | Kyungpook National University Hospital |
Organization Type | Medical Institute |
Project ID |
6. Sponsor Organization
1. Sponsor Organization | |
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Organization Name | Kyungpook National University Hospital |
Organization Type | Medical Institute |
7. Study Summary
Lay Summary | Alpha lipoic acid is a cofactor of mitochondrial respiratory enzymes, scavenging free radicals, blocking metal ions, and exhibiting the effect of recycling antioxidants. As a result of these antioxidant effects, in several animal and clinical trials, the association between anti-cancer toxic hearing loss and noise-induced hearing loss was reported. In our previous studies, protective effects on cisplatin-induced ototoxicity were also confirmed through animal experiments. In this study, steroid monotherapy (systemic steroid injection and steroid tympanic injection) and combination therapy to add alpha lipoic acid, which has recently been introduced as a treatment method for ototoxic and noise-induced hearing loss, in the treatment of patients with sudden and noise-induced hearing loss.we aim to analyze the treatment effect on the pure tone hearing threshold and speech hearing test results over time. We intend to proceed with the study on the assumption that there will be an additional effect of hearing improvement by using alphalipoic acid, an antioxidant that has a large preventive effect in ototoxicity and noise-induced hearing loss. Among patients treated for sudden and noise-induced hearing loss, the group received thioctic acid once a day (10 days) while performing systemic steroid + intratympanic steroid injection (3 times), and only systemic steroid + intratympanic steroid injection (3 times) It was planned to be divided into the groups administered and observed for a year as a case-control study. |
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8. Study Design
Study Type | Observational Study |
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Observational Study Model | Case-control |
Time Perspective | Prospective |
Target Number of Participant | 100 |
Cohort/Group Number | 2 |
Cohort/ Group 1 |
Cohort/Group Label Control group |
Cohort/Group Description Control group(standard treatment) :Intravenous injection of steroid (10 mg of dexamethasone once a day for 5 days-> 5 mg of dexamethasone once a day for 5 days) + Steroid intratympanic injection (0.4 to 0.5 cc in 1 ample of dexamethasone) once every 2 days (3 times in total during the hospital stay) |
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Cohort/ Group 2 |
Cohort/Group Label Experimental group (addition of alpha lipoic acid) |
Cohort/Group Description Experimental group (addition of alpha lipoic acid) : Control group protocol (standard treatment) + 600mg of alpha lipoic acid (intravenous injection once a day for 10 days during hospitalization) |
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Biospecimen Collection & Archiving |
Not collect nor Archive |
Biospecimen Description |
9. Subject Eligibility
Study Population Description | Adults (20 years of age or older) who are diagnosed with sudden hearing loss and noise-induced hearing loss and treat in our hospitalization |
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Sampling Method | Prospective, open, block randomization, probability sample |
Condition(s)/Problem(s) |
* (H60-H95)Diseases of the ear and mastoid process (H91.20)Sudden idiopathic hearing loss, unilateral sudden hearing loss |
Rare Disease | No |
Inclusion Criteria |
Gender Both |
Age 20Year~80Year |
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Description sudden hearing loss A. Hearing loss [30 dB in 3 consecutive frequency within 72 h] B. Sudden hearing loss must be unilateral. Noise-induced hearing loss- trensient threshold shift) A. A temporary shift in the auditory threshold suddenly after exposure to a high level of noise Common inclusion criteria A. No initial treatment before; B. Must apply within 2 weeks after onset; C. Age more than 20 years |
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Exclusion Criteria |
A. Presence of acute or chronic otitis media; B. Had previous otologic surgery; C. Trauma; D. Presence of a neoplasm; E. Recent application of radiotherapy and/or chemotherapy; F. Recent use of ototoxic drugs; G. Syphilis; H. Retro-cochlear lesion. I. Age < 20 years J. Pregnant, lactating, possibly pregnant women K. Cisplatin user L. Severe liver disease or kidney disease M. Uncontrolled DM N. Active infectious disease ( e.g. herpes zoster, chicken pox, tuberculosis) O. Cataract, glaucoma, severe osteoporosis P. Seizure, myasthenia gravis Q. Hypothyroidism, congestive heart disease R. Recent bowl surgery S. Ischemic heart disease, embolism. T. Patients who have hypersensitivity reaction of alpha-lipoic acid or steroid |
Healthy Volunteers | No |
10. Outcome Measure(s)
Type of Primary Outcome | Efficacy | |
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Primary Outcome(s) 1 | ||
Outcome | To compare the effect of treatment with steroid therapy and alpha-lipoic acid in combination with sudden hearing loss or noise-induced hearing loss over time and the results of pure tone hearing threshold (change in pure tone hearing threshold by frequency) |
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Timepoint | Before treatment, 10 days later, 20 days later, 1 month, 3 months, 1 year |
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Secondary Outcome(s) 1 | ||
Outcome | Changes in speech discernment |
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Timepoint | Before treatment, 10 days later, 20 days later, 1 month, 3 months, 1 year |
11. Study Results and Publication
Result Registered | No |
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12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)
Sharing Statement | No |
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