<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/NCT03280914</url>
  </required_header>
  <id_info>
    <org_study_id>GDREC2016275H(R1)</org_study_id>
    <nct_id>NCT03280914</nct_id>
  </id_info>
  <brief_title>Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community</brief_title>
  <official_title>Epidemiology and Intervention of Obstructive Sleep Apnea Based on Community: a Real World Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This observational study in a real-world community was designed to perform epidemiological&#xD;
      investigation and assess effect of CPAP intervention of obstructive sleep apnea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with obstructive sleep apnea receiving CPAP or not would be observed in years.&#xD;
      Primarily Impact of CPAP on health assessment andx control rate of hypertension would&#xD;
      evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Health assessment</measure>
    <time_frame>From 1st Aug 2017 to 31st Dec 2020</time_frame>
    <description>Health assessment would be performed by 36-Item Short-Form Health Survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep quality</measure>
    <time_frame>From 1st Aug 2017 to 31st Dec 2020</time_frame>
    <description>Sleep quality would be performed by Pittsburgh Sleep Quality Index.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Psychological assessment</measure>
    <time_frame>From 1st Aug 2017 to 31st Dec 2020</time_frame>
    <description>Psychological assessment would be performed by Hospital Anxiety and Depression Scale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Control rate of hypertension</measure>
    <time_frame>From 1st Aug 2017 to 31st Dec 2020</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of chronic diseases</measure>
    <time_frame>From 1st Aug 2017 to 31st Dec 2025</time_frame>
    <description>Chronic diseases include hypertension, coronary heart disease, stroke and diabetes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death from all-cause</measure>
    <time_frame>From 1st Aug 2017 to 31st Dec 2025</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medical cost</measure>
    <time_frame>From 1st Aug 2017 to 31st Dec 2025</time_frame>
    <description>Medical fee, annually time of outpatient visit and hospitalization</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">103</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Hypertension</condition>
  <condition>Obesity</condition>
  <condition>Diabetes</condition>
  <condition>Hyperdiploid</condition>
  <condition>Fatigue Syndrome, Chronic</condition>
  <condition>Insomnia Chronic</condition>
  <condition>Quality of Life</condition>
  <condition>Economic Problems</condition>
  <condition>Compliance, Patient</condition>
  <condition>Health Impairment</condition>
  <arm_group>
    <arm_group_label>CPAP group</arm_group_label>
    <description>Automatic Continuous Positive Airway Pressure treatment and usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care group</arm_group_label>
    <description>Usual care without Continuous Positive Airway Pressure treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Auto-CPAP</intervention_name>
    <description>Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea</description>
    <arm_group_label>CPAP group</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum lipid, glucose.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients would be recruited from Community of Huanghua Road.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1) AHI &gt;= 5 events/h&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Any condition which in the opinion of researched makes the eligible participants&#xD;
             unsuitable for this study, such as severe COPD, heart failure in NYHA class III to IV,&#xD;
             and others&#xD;
&#xD;
          2. Any condition potentially precluding follow-up visits, such as sereve insomnia,&#xD;
             cognitive behavioral disorder, and others&#xD;
&#xD;
          3. Patients receiving CPAP treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qiong Ou, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Community of Huanghua Road</name>
      <address>
        <city>Guangzhou</city>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>August 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>February 5, 2020</last_update_submitted>
  <last_update_submitted_qc>February 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>obstructive sleep apnea</keyword>
  <keyword>real world</keyword>
  <keyword>community</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fatigue Syndrome, Chronic</mesh_term>
    <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>No</sharing_ipd>
    <ipd_description>Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.</ipd_description>
  </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/NCT03280914
org study id: GDREC2016275H(R1)
nct id: NCT03280914
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This observational study in a real-world community was designed to perform epidemiological
      investigation and assess effect of CPAP intervention of obstructive sleep apnea.
Patients with obstructive sleep apnea receiving CPAP or not would be observed in years.
      Primarily Impact of CPAP on health assessment andx control rate of hypertension would
      evaluated.
observational model: Case-Control
time perspective: Prospective
measure: Health assessment
time frame: From 1st Aug 2017 to 31st Dec 2020
description: Health assessment would be performed by 36-Item Short-Form Health Survey.
measure: Sleep quality
time frame: From 1st Aug 2017 to 31st Dec 2020
description: Sleep quality would be performed by Pittsburgh Sleep Quality Index.
measure: Psychological assessment
time frame: From 1st Aug 2017 to 31st Dec 2020
description: Psychological assessment would be performed by Hospital Anxiety and Depression Scale.
measure: Control rate of hypertension
time frame: From 1st Aug 2017 to 31st Dec 2020
measure: Incidence of chronic diseases
time frame: From 1st Aug 2017 to 31st Dec 2025
description: Chronic diseases include hypertension, coronary heart disease, stroke and diabetes.
measure: Death from all-cause
time frame: From 1st Aug 2017 to 31st Dec 2025
measure: Medical cost
time frame: From 1st Aug 2017 to 31st Dec 2025
description: Medical fee, annually time of outpatient visit and hospitalization
arm group label: CPAP group
description: Automatic Continuous Positive Airway Pressure treatment and usual care
arm group label: Usual care group
description: Usual care without Continuous Positive Airway Pressure treatment
intervention type: Device
intervention name: Auto-CPAP
description: Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea
arm group label: CPAP group
Serum lipid, glucose.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Qiong Ou, M.D.
role: Principal Investigator
affiliation: Guangdong Provincial People's Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Fatigue Syndrome, Chronic
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No
ipd description: Previous research plan submitted to the Ethics Committee has stated the participant information not be shared.