xml: <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/NCT06027424</url>
    </required_header>
    <id_info>
      <org_study_id>2022-07-013CC</org_study_id>
      <nct_id>NCT06027424</nct_id>
    </id_info>
    <brief_title>Blood Pressure and Obstructive Sleep Apnea</brief_title>
    <official_title>The Changes in Blood Pressure in Patients With Obstructive Sleep Apnea Following an Overnight Sleep</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taipei Veterans General Hospital, Taiwan</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taipei Veterans General Hospital, Taiwan</source>
    <oversight_info>
      <has_dmc>No</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>
        Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and&#xD;
        hypertension in a dose-response manner, independent of confounding variables such as age,&#xD;
        smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea&#xD;
        index (AHI). The relationship between AHI and changes of blood pressure deserves further&#xD;
        investigation.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Approximately 50% of patients with obstructive sleep apnea (OSA) have hypertension; up to 30%&#xD;
        of patients with hypertension have OSA, and the prevalence is even higher in those of&#xD;
        resistant hypertension. OSA is conventionally diagnosed and graded by apnea-hypopnea index&#xD;
        (AHI). This retrospective study aimed to determine if OSA severity and AHI have effect on&#xD;
        blood pressure measurements and the nocturnal changes following an overnight sleep.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">October 26, 2022</start_date>
    <completion_date type="Actual">July 16, 2023</completion_date>
    <primary_completion_date type="Actual">February 28, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Blood pressure, before sleep and after awakening</measure>
      <time_frame>20:30 pm ~ 06:00 am next day</time_frame>
      <description>Measurement of blood pressure at two time points: before sleep and after awakening</description>
    </primary_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Actual">2037</enrollment>
    <condition>The Effects of Obstructive Sleep Apnea on Blood Pressure Measurement</condition>
    <arm_group>
      <arm_group_label>Non-OSA</arm_group_label>
      <description>AHI &lt; 5 events/h (AHI, apnea-hypopnea index, the number of apneas and hypopneas per hour of total sleep time)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Mild OSA</arm_group_label>
      <description>5 events/h ≤ AHI &lt; 15 events/h</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Moderate OSA</arm_group_label>
      <description>15 events/h ≤ AHI &lt; 30 events/h</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Severe OSA</arm_group_label>
      <description>AHI ≥ 30 events/h</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals who underwent full-night polysomnography at Taipei VGH for symptoms related to&#xD;
          obstructive sleep apnea, such as snoring and daytime somnolence&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          (1). Individuals who underwent full-night polysomnography at Taipei VGH for symptoms&#xD;
          related to obstructive sleep apnea, such as snoring and daytime somnolence; (2).&#xD;
          Feasibility to measure BP via wrist monitors; (3). Confirmation of wakefulness through&#xD;
          electroencephalography.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (1). Failure to measure BP via wrist monitors; (2). Age younger than 18 years; (3). Sleep&#xD;
          efficiency less than 50%; (4). Central sleep apnea ≥ 50%&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Taipei Veterans General Hospital</name>
        <address>
          <city>Taipei</city>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 31, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </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>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06027424
  org study id: 2022-07-013CC
  nct id: NCT06027424
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Bidirectional and causal relationship exists between obstructive sleep apnea (OSA) and
        hypertension in a dose-response manner, independent of confounding variables such as age,
        smoking, and body mass index. OSA is conventionally diagnosed and graded by apnea-hypopnea
        index (AHI). The relationship between AHI and changes of blood pressure deserves further
        investigation.
  Approximately 50% of patients with obstructive sleep apnea (OSA) have hypertension; up to 30%
        of patients with hypertension have OSA, and the prevalence is even higher in those of
        resistant hypertension. OSA is conventionally diagnosed and graded by apnea-hypopnea index
        (AHI). This retrospective study aimed to determine if OSA severity and AHI have effect on
        blood pressure measurements and the nocturnal changes following an overnight sleep.
  observational model: Case-Only
  time perspective: Retrospective
  measure: Blood pressure, before sleep and after awakening
  time frame: 20:30 pm ~ 06:00 am next day
  description: Measurement of blood pressure at two time points: before sleep and after awakening
  arm group label: Non-OSA
  description: AHI < 5 events/h (AHI, apnea-hypopnea index, the number of apneas and hypopneas per hour of total sleep time)
  arm group label: Mild OSA
  description: 5 events/h ≤ AHI < 15 events/h
  arm group label: Moderate OSA
  description: 15 events/h ≤ AHI < 30 events/h
  arm group label: Severe OSA
  description: AHI ≥ 30 events/h
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Taiwan
  responsible party type: Sponsor
  mesh term: Apnea
  mesh term: Sleep Apnea Syndromes
  mesh term: Sleep Apnea, Obstructive
  sharing ipd: No