<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03782844</url>
  </required_header>
  <id_info>
    <org_study_id>2011 No. 5</org_study_id>
    <nct_id>NCT03782844</nct_id>
  </id_info>
  <brief_title>Efficacy of Simple Continuous Positive Airway Pressure on Patients With Obstructive Sleep Apnea</brief_title>
  <official_title>Efficacy of Simple Continuous Positive Airway Pressure on Patients With Obstructive Sleep Apnea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State Key Laboratory of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State Key Laboratory of Respiratory Disease</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obstructive sleep apnea (OSA) is a common and frequently-occurring disease. The incidence of&#xD;
      OSA is more than 4% in general population, and as high as 20% - 40% in the elderly. At&#xD;
      present, CPAP machines commonly used for OSA treatment includes traditional pressure fixed&#xD;
      single-level CPAP machine and automatic pressure regulation CPAP machine. Studies have shown&#xD;
      that the CPAP treatment pressure of OSA patients is normally below 11 cmH2O. Since the&#xD;
      condition of OSA patients and the required CPAP treatment pressure may change over time, a&#xD;
      CPAP machine with automatic pressure regulation function may theoretically better meet the&#xD;
      needs of treatment. However, a recent large-scale clinical study with an average follow-up of&#xD;
      four years showed that there was little need to change CPAP treatment pressure after&#xD;
      titration. Although different types of CPAP have different functions, the basic principle is&#xD;
      to keep the upper airway open and unobstructed to eliminate sleep apnea and hypopnea by&#xD;
      continuously applying positive pressure to the upper respiratory tract through an air pump. A&#xD;
      complex CPAP machine with functions such as pressure regulation, boost delay, end-expiratory&#xD;
      pressure release will cost more than a single-function CPAP machine. Some patients from poor&#xD;
      areas, even with severe OSA, may give up treatment when they can not afford CPAP machines&#xD;
      that have not yet been included in national health insurance in China. In view of the current&#xD;
      economic level in China, it is urgent to find an inexpensive and effective CPAP machine for&#xD;
      the treatment of OSA and related complications. Recently, Guangzhou Yinghui Medical&#xD;
      Technology Co., Ltd.and State Key Laboratory of Respiratory Disease have developed a new&#xD;
      simple CPAP machine. The CPAP treatment pressure is fixed at the factory to 6 cm H2O (SKL), 8&#xD;
      cm H2O (SKM) and 10 cm H2O (SKH). Compared to traditional CPAP machine, only a power switch&#xD;
      button is attached on the body, and the additional adjustment devices including display&#xD;
      screen are removed, which not only reduces the cost of the CPAP machine, but also facilitates&#xD;
      the operation of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Design: A randomized, cross-over and double blind study . Objective: To investigate the&#xD;
      efficacy of simple device of continuous positive airway pressure (CPAP) in the treatment of&#xD;
      obstructive sleep apnea (OSA). Methods: A randomized, cross-over and double blind study would&#xD;
      be performed on 100 OSA patients using both simple CPAP and traditional CPAP during overnight&#xD;
      polysomnography. Pressure for CPAP treatment would be manual titrated. The sleep apnea&#xD;
      hypopnea index (AHI), arousal index (ArI), Oxygen desaturation Index (ODI), sleep structure&#xD;
      and the preference of CPAP model were to be observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2019</start_date>
  <completion_date type="Actual">October 15, 2019</completion_date>
  <primary_completion_date type="Actual">October 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea Hypopnea Index</measure>
    <time_frame>One full night</time_frame>
    <description>Total number of apneas and hypopneas×60/total sleep time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Arousal Index</measure>
    <time_frame>One full night</time_frame>
    <description>Total number of arousals×60/total sleep time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oxygen Desaturation Index</measure>
    <time_frame>One full night</time_frame>
    <description>Total number of oxygen desaturations≥3%×60/total sleep time</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep structure</measure>
    <time_frame>One full night</time_frame>
    <description>Sleep stage distribution(N1, N2, N3, NREM)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse effects</measure>
    <time_frame>Onefull night</time_frame>
    <description>Using questionnaire to assess adverse effects including dyspnea, noise, bloating, et al</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Continuous Positive Airway Pressure</condition>
  <condition>Polysomnography</condition>
  <arm_group>
    <arm_group_label>Conventional fixed CPAP and simple CPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group were manually titrated . They were treated with conventional fixed pressure CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Auto CPAP and simple CPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group after being manually titrated were treated with Auto RemStar CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Simple CPAP+Conventional fixed CPAP</intervention_name>
    <description>Patients used simple CPAP and conventional fixed CPAP during overnight polysomnography.</description>
    <arm_group_label>Conventional fixed CPAP and simple CPAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Simple CPAP + Auto CPAP</intervention_name>
    <description>Patients used simple CPAP and Auto CPAP during overnight polysomnography.</description>
    <arm_group_label>Auto CPAP and simple CPAP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Willing to participate after informed consent&#xD;
&#xD;
          2. Males and females, any race and aged≥18yeras&#xD;
&#xD;
          3. Objectively confirmed OSA with an apnoea-hypopnoea- index (AHI)≥5/h by overnight&#xD;
             polysomnography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Central Sleep Apnoea/Cheyne Stokes Respiration&#xD;
&#xD;
          2. Opioid or sedative use; Alcohol abuse&#xD;
&#xD;
          3. Nasal congestion or tonsils more than Ⅱ degrees enlarged&#xD;
&#xD;
          4. Optimal treatment CPAP pressure over 10cmH2O&#xD;
&#xD;
          5. Poor understanding or being disabled&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>May 20, 2021</last_update_submitted>
  <last_update_submitted_qc>May 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 25, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>State Key Laboratory of Respiratory Disease</investigator_affiliation>
    <investigator_full_name>Yuan-Ming Luo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03782844
org study id: 2011 No. 5
nct id: NCT03782844
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Obstructive sleep apnea (OSA) is a common and frequently-occurring disease. The incidence of
      OSA is more than 4% in general population, and as high as 20% - 40% in the elderly. At
      present, CPAP machines commonly used for OSA treatment includes traditional pressure fixed
      single-level CPAP machine and automatic pressure regulation CPAP machine. Studies have shown
      that the CPAP treatment pressure of OSA patients is normally below 11 cmH2O. Since the
      condition of OSA patients and the required CPAP treatment pressure may change over time, a
      CPAP machine with automatic pressure regulation function may theoretically better meet the
      needs of treatment. However, a recent large-scale clinical study with an average follow-up of
      four years showed that there was little need to change CPAP treatment pressure after
      titration. Although different types of CPAP have different functions, the basic principle is
      to keep the upper airway open and unobstructed to eliminate sleep apnea and hypopnea by
      continuously applying positive pressure to the upper respiratory tract through an air pump. A
      complex CPAP machine with functions such as pressure regulation, boost delay, end-expiratory
      pressure release will cost more than a single-function CPAP machine. Some patients from poor
      areas, even with severe OSA, may give up treatment when they can not afford CPAP machines
      that have not yet been included in national health insurance in China. In view of the current
      economic level in China, it is urgent to find an inexpensive and effective CPAP machine for
      the treatment of OSA and related complications. Recently, Guangzhou Yinghui Medical
      Technology Co., Ltd.and State Key Laboratory of Respiratory Disease have developed a new
      simple CPAP machine. The CPAP treatment pressure is fixed at the factory to 6 cm H2O (SKL), 8
      cm H2O (SKM) and 10 cm H2O (SKH). Compared to traditional CPAP machine, only a power switch
      button is attached on the body, and the additional adjustment devices including display
      screen are removed, which not only reduces the cost of the CPAP machine, but also facilitates
      the operation of patients.
Study Design: A randomized, cross-over and double blind study . Objective: To investigate the
      efficacy of simple device of continuous positive airway pressure (CPAP) in the treatment of
      obstructive sleep apnea (OSA). Methods: A randomized, cross-over and double blind study would
      be performed on 100 OSA patients using both simple CPAP and traditional CPAP during overnight
      polysomnography. Pressure for CPAP treatment would be manual titrated. The sleep apnea
      hypopnea index (AHI), arousal index (ArI), Oxygen desaturation Index (ODI), sleep structure
      and the preference of CPAP model were to be observed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Apnea Hypopnea Index
time frame: One full night
description: Total number of apneas and hypopneas×60/total sleep time
measure: Arousal Index
time frame: One full night
description: Total number of arousals×60/total sleep time
measure: Oxygen Desaturation Index
time frame: One full night
description: Total number of oxygen desaturations≥3%×60/total sleep time
measure: Sleep structure
time frame: One full night
description: Sleep stage distribution(N1, N2, N3, NREM)
measure: Adverse effects
time frame: Onefull night
description: Using questionnaire to assess adverse effects including dyspnea, noise, bloating, et al
arm group label: Conventional fixed CPAP and simple CPAP
arm group type: Experimental
description: Participants in this group were manually titrated . They were treated with conventional fixed pressure CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography.
arm group label: Auto CPAP and simple CPAP
arm group type: Experimental
description: Participants in this group after being manually titrated were treated with Auto RemStar CPAP and Simple CPAP for two separate nights in random order monitored by full polysomnography.
intervention type: Device
intervention name: Simple CPAP+Conventional fixed CPAP
description: Patients used simple CPAP and conventional fixed CPAP during overnight polysomnography.
arm group label: Conventional fixed CPAP and simple CPAP
intervention type: Device
intervention name: Simple CPAP + Auto CPAP
description: Patients used simple CPAP and Auto CPAP during overnight polysomnography.
arm group label: Auto CPAP and simple CPAP
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: State Key Laboratory of Respiratory Disease
investigator full name: Yuan-Ming Luo
investigator title: Professor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: Undecided