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The effect of type of mask on CPAP and DISE parameters

Status Approved

  • First Submitted Date

    2020/12/18

  • Registered Date

    2020/12/29

  • 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
    KCT0005709
    Unique Protocol ID CNUH-2020-318
    Public/Brief Title Mask-DISE
    Scientific Title The effect of type of mask on CPAP and DISE parameters
    Acronym Mask-DISE
    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-2020-318
    Approval Date 2020-10-29
    Institutional Review Board Name Chonnam National University Hospital BIomedical Research Institute
    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 hyunchae yang
    Title Assistant professor
    Telephone +82-62-220-6776
    Affiliation Chonnam National University Hospital
    Address jebonglo-42, Dong-gu, Gwang-ju
    Contact Person for Public Queries
    Name hyunchae yang
    Title Assistant professor
    Telephone +82-62-220-6776
    Affiliation Chonnam National University Hospital
    Address jebonglo-42, Dong-gu, Gwang-ju
    Contact Person for Updating Information
    Name hyunchae yang
    Title Assistant professor
    Telephone +82-62-220-6776
    Affiliation Chonnam National University Hospital
    Address jebonglo-42, 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 Completed
    Date of First Enrollment 2020-11-06 Actual
    Target Number of Participant 30
    Primary Completion Date 2021-03-16 , Actual
    Study Completion Date 2021-03-16 , Actual
    Recruitment Status by Participating Study Site 1
    Name of Study Chonnam National University Hospital
    Recruitment Status Completed
    Date of First Enrollment 2020-11-06 ,
  • 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-2020-318
  • 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
    Purpose : This study aims to compare the effectiveness of relief of obstruction in the upper airway's anatomical areas according to the type of mask. 
    
    Background : Obstructive Sleep Apnea is a common sleep-related breathing disorder affecting the adult aged 40 to 70 in the Republic of South Korea, with the prevalence rate of 16% in women and 27% in men. The number of people treated for sleep disorders ranges from 228,000 in 2008 to 357,000 in 2012 in the last five years. This rate was increased 1.57 times, averaging 11.9% annually. The total medical expenses were 19.5 billion won in 2008 and surged to 35.3 billion won in 2012. Untreated OSA can lead to serious medical consequences such as cardiovascular, cerebrovascular, and psychoneurological problems. These increasing complications will result in an average of $1950 to $3899 additional medical expenses per patient in a year. Thus, these indirectly give rise to the socio-economic burden.
     Sleep-related breathing disorder is recognized as a chronic disease that requires comprehensive management in the long run. The primary definitive treatment is via PAP therapy. It is first proposed in the year 2018 in the Republic of South Korea that the health insurance covers the treatment with PAP.
     OSA is defined as repetitive narrowing or blockage of the upper airway (UA) during sleep. Therefore, PAP therapy's mechanism is by splinting the upper airway with applied positive pressure to prevent the narrowing through a mask.
     CPAP therapy is generally known to be the primary treatment for OSA. However, the long-term compliance rate is measured at about 40% worldwide, and it is reported to be even lower in the Republic of South Korea.
     Drug Induced Sleep Endoscopy(DISE) is a procedure performed by induces the patient to a natural sleep using an appropriate sedative anaesthetics. During the process, the snoring pattern is observed, and the multi-level sites of the UA are inspected endoscopically. These sites include nasal septum, adenoids, soft palate, pharynx, tonsils, tongue base, and epiglottis. This procedure is useful for looking for obstruction sites and determining the appropriate necessary therapy according to the level. Besides that, simulation maneuvers such as jaw thrust, application of PAP device, oral appliance therapy, and positional therapy can be done on the patients to check for UA's improvement during DISE. 
     Although PAP therapy is the definitive treatment for patients with sleep-related breathing disorders, low compliance rates remain the main concern. The mask may have an effect on patient compliance. A randomized crossover study by Mortimore et al. which showed that 20 patients with moderate to severe OSA have 1-hour lower adherence in the oronasal mask than to nasal CPAP during the CPAP titration for four weeks duration each. 19 out of the 20 participants also preferred the nasal mask. Therefore, we want to investigate and confirm the upper airway oronasal mask's effect (full face mask) in this study. The investigation steps would be performing DISE in all patients suspected of sleep apnea, followed by continuous positive airway pressure (CPAP). Each mask is used to assess the anatomical sites of the UA. In addition, the pressure-relieving sites of obstruction with each mask are also documented.
  • 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 Single
    Blinded Subject Subject
    Allocation RCT
    Intervention Type Medical Device  
    Intervention Description
    A randomized crossover study was conducted. It is divided into two groups: Group 1 and Group 2. This study's main principle is the random assignment of the groups by simple random allocation (simple randomization).  The program used is Random allocation software version 1.0
    Group 1
    -	Group 1 is the patient on the nasal mask during CPAP-DISE. The patient will be wearing the nasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increases, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value.  Confirm the pressure which improves the anatomical obstruction sites by the method of 2cmH20 up/1cmH20 down.  
    
    -	Once completion of nasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above.
    
    Group 2
    -	Group 2 is the patient on the oronasal mask during CPAP-DISE. The patient will be wearing the oronasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increase, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value.  Confirm the pressure which improves the anatomical obstruction sites by a method of 2cmH20 up/1cmH20 down.  
    
    -	Once completion of oronasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above.
    Number of Arms 2
    Arm 1

    Arm Label

    Nasal mask- oronasal mask

    Target Number of Participant

    15

    Arm Type

    Experimental

    Arm Description

    Group 1 is the patient on the nasal mask during CPAP-DISE. The patient will be wearing the nasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increases, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value.  Confirm the pressure which improves the anatomical obstruction sites by the method of 2cmH20 up/1cmH20 down.  
    
    -	Once completion of nasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above.
    Arm 2

    Arm Label

    Oronasal mask-nasal mask

    Target Number of Participant

    15

    Arm Type

    Active comparator

    Arm Description

    Group 2 is the patient on the oronasal mask during CPAP-DISE. The patient will be wearing the oronasal mask upon performing DISE. The positive pressure is increased by two units with the starting pressure of 4cmH2O up to 20cmH20. Upon each pressure increase, the velum, oropharyngeal, tongue base, and epiglottic sites are evaluated for any obstruction. The pressure at which obstruction sites are relieved is documented. Then, lower the pressure by 1cmH20 to confirm the obstruction site value.  Confirm the pressure which improves the anatomical obstruction sites by a method of 2cmH20 up/1cmH20 down.  
    
    -	Once completion of oronasal mask CPAP during DISE, the nasal mask is changed to the oronasal mask. The steps are repeated the same as above.
  • 9. Subject Eligibility

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

    Sleep Apnea, Obstructive
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    18Year~No Limit

    Description

    -Patients over the age of 18
    -Symptoms of severe snoring or sleep apnea which warrant indication for polysomnography
    -Patients who agreed to drug-induced sleep endoscopy
    -Patients who voluntarily agree to participate in this study
    Exclusion Criteria
    -Pregnant or lactating women
    -Pulmonary disease, severe lung disease, neuromuscular disease, heart failure, and multiple comorbidities
    -Patients who disagree for polysomnography and DISE
    -Patients who are contraindicated for DISE such as those with central sleep apnea, restless leg syndrome, parasomnias
    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 determine the CPAP pressure value on the resolution of obstruction in the anatomical sites of UA according to the Velum, Oropharynx, Tongue base and Epiglottis (VOTE) classification with DISE
    Timepoint
    Drug Induced Sleep Endoscopy
    Secondary Outcome(s) 1
    Outcome
    To examine each anatomical sites of UA according to VOTE at each positive pressure during DISE
    Timepoint
    Drug Induced Sleep Endoscopy
  • 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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