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The effect of partial epiglottectomy on the parameters of positive airway pressure treatment in patients with obstructive sleep apnea

Status Approved

  • First Submitted Date

    2019/09/06

  • Registered Date

    2021/01/07

  • Last Updated Date

    2021/05/18

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
    KCT0005738
    Unique Protocol ID CNUH-2019-232
    Public/Brief Title The effect of partial epiglottectomy on the parameters of positive airway pressure treatment in patients with obstructive sleep apnea
    Scientific Title The effect of partial epiglottectomy on the parameters of positive airway pressure treatment in patients with obstructive sleep apnea
    Acronym OSAS-epiglottectomy
    MFDS Regulated Study No
    IND/IDE Protocol No
    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 CNUH-2019-232
    Approval Date 2019-08-30
    Institutional Review Board Name chonnam national university hospital institutional review board
    Institutional Review Board Address 42, Jebong-ro, Dong-gu, Gwangju
    Institutional Review Board Telephone 062-220-5257
    Data Monitoring Committee No
  • 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 hyungchae yang
    Title Dr
    Telephone +82-62-220-6776
    Affiliation Chonnam National University Hospital
    Address 42 Jebongro dong-gu Gwang-ju
    Contact Person for Public Queries
    Name hyungchae yang
    Title Dr
    Telephone +82-62-220-6776
    Affiliation Chonnam National University Hospital
    Address 42 Jebongro dong-gu Gwang-ju
    Contact Person for Updating Information
    Name hyungchae yang
    Title Dr
    Telephone +82-62-220-6776
    Affiliation Chonnam National University Hospital
    Address 42 Jebongro dong-gu Gwang-ju
  • 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 Withdrawn
    Date of First Enrollment 2019-09-10 Actual
    Target Number of Participant 88
    Primary Completion Date 2021-05-18 , Actual
    Study Completion Date 2021-05-18 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Withdrawn Withdrawn Reason : 코로나19사태로 인하여 연구대상자 등록및 추적관찰의 어려움
    Date of First Enrollment 2019-09-10 ,
  • 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 Chonnam National University Hospital
    Organization Type Medical Institute
    Project ID CNUH-2019-232
  • 6. Sponsor Organization

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

    Study Summary Information
    Lay Summary
    The objectives of the study drug induced sleep endoscopy on the epiglottal closure of the obstructive sleep apnea patients who have been found in the ablation patient's quality of life and the quality of the epiglottis.Long and variable used yangapkki jeogeungdo to check the impact on.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Medical Device, /Procedure/Surgery  
    Intervention Description
    Group 1 If the drug-induced endoscopic examination confirms the closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, perform a laryngeal partial resection to mitigate the closing of the larynx. For a period (approximately 1 month) waiting before surgery, automatic positive pressure treatment is performed, which is a standard treatment for sleep apnea patients. Conduct a questionnaire that evaluates sleep conditions before and after surgery. Patients in the group start to wear the positive pressure after surgery. After surgery, survey questionnaires and positive pressure usage performance during outpatient tracking after 1, 3, 6, 12 months
    
    Group 2 If the drug-induced endoscopy shows closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, conduct a positive pressure test (CPAP titration). Automatic positive pressure treatment is performed until the proper pressure inspection of the positive pressure system is conducted, and continuous positive pressure treatment is performed with the appropriate pressure determined after the proper pressure test of the positive pressure. Collect the questionnaire PSQI and ESS that assess the sleep condition after starting treatment of the constant positive pressure as shown in Group 1. In addition, the results of questionnaires and positive pressure units are investigated for outpatient tracking after 1, 3, 6, 12 months.
    Number of Arms 2
    Arm 1

    Arm Label

    CPAP Use

    Target Number of Participant

    44

    Arm Type

    Experimental

    Arm Description

    If the drug-induced endoscopy shows closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, conduct a positive pressure test (CPAP titration). Automatic positive pressure treatment is performed until the proper pressure inspection of the positive pressure system is conducted, and continuous positive pressure treatment is performed with the appropriate pressure determined after the proper pressure test of the positive pressure. Collect the questionnaire PSQI and ESS that assess the sleep condition after starting treatment of the constant positive pressure as shown in Group 1. In addition, the results of questionnaires and positive pressure units are investigated for outpatient tracking after 1, 3, 6, 12 months.
    Arm 2

    Arm Label

    epiglottectomy

    Target Number of Participant

    44

    Arm Type

    Active comparator

    Arm Description

    If the drug-induced endoscopic examination confirms the closure of the larynx in patients with an apnea-low respiration index (AHI) or higher, perform a laryngeal partial resection to mitigate the closing of the larynx. For a period (approximately 1 month) waiting before surgery, automatic positive pressure treatment is performed, which is a standard treatment for sleep apnea patients. Conduct a questionnaire that evaluates sleep conditions before and after surgery. Patients in the group start to wear the positive pressure after surgery. After surgery, survey questionnaires and positive pressure usage performance during outpatient tracking after 1, 3, 6, 12 months
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (G00-G99)Diseases of the nervous system 
       (G47.30)Obstructive sleep apnoea 

    obstructive sleep apnea
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    - over the age of 18
    - those who suffer from severe snoring or sleep apnea in the polygamous sleep test with AHI > 15 or higher, or those who suffer from severe symptoms among patients with AHI > 5 or higher
    - those who showed the occipital closure of the larynx during a drug-induced sleep endoscopy
    - those who voluntarily agreed to participate in this study in writing.
    Exclusion Criteria
    - A woman who may be pregnant or pregnant; a nursing woman.
    - patients with suspected central sleep apnea or other sleep disorders such as insomnia, anxiety syndrome, narcolepsy, circadian disorder, and event sleep
    - a person who suffers from lung or nerve root diseases or heart failure with a moderate degree or higher, which can lead to reduced accuracy of sleep polydialysis.
    - those who do not agree with the survey and the multi-sleep test
    Healthy Volunteers
  • 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
    Continuous positive airway pressure(CPAP) score
    Timepoint
    1,3,6,12 months
    Primary Outcome(s) 2
    Outcome
    visual analog scale score(VAS score)
    Timepoint
    1,3,6,12 months
    Secondary Outcome(s) 1
    Outcome
    Korean Version of the Pittsburgh Sleep Quality Index(PSQI-K)
    Timepoint
    1,3,6,12 months
    Secondary Outcome(s) 2
    Outcome
    Korean version of the Epworth sleepness scale(ESS)
    Timepoint
    1,3,6,12 months
    Secondary Outcome(s) 3
    Outcome
    The reflux sumptom index(RSI)
    Timepoint
    1,3,6,12 months
  • 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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