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The efficacy of alpha-lipoic acid on hearing results and tinnitus in idiopathic sudden sensorineural hearing loss and noise-induced hearing loss, prospective study

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

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0004863
    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

    Institutional Review Board Information
    Board Approval Status Submitted approval
    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 Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    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

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    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

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Kyungpook National University Hospital
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Kyungpook National University Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    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.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    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)
    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)
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    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
    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

    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
    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)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    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)
    Timepoint
    Before treatment, 10 days later, 20 days later, 1 month, 3 months, 1 year
    Secondary Outcome(s) 1
    Outcome
    Changes in speech discernment
    Timepoint
    Before treatment, 10 days later, 20 days later, 1 month, 3 months, 1 year
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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