<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/NCT03230110</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00081272</org_study_id>
    <nct_id>NCT03230110</nct_id>
  </id_info>
  <brief_title>OSA in Pregnant Women With Chronic HTN</brief_title>
  <acronym>OSA-CHTN</acronym>
  <official_title>Obstructive Sleep Apnea Among Pregnant Women With Chronic Hypertension</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society for Obstetric Anesthesia and Perinatology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to identify whether pregnant women with chronic hypertension are&#xD;
      at significantly higher risk of having undiagnosed OSA and should be routinely screened with&#xD;
      home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks&#xD;
      gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be&#xD;
      enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood&#xD;
      pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment&#xD;
      for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the&#xD;
      chronic HTN group. The two groups will be matched for BMI to control for the effect of&#xD;
      obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs&#xD;
      between patients with chronic HTN and normotensive controls, will be assessed with a&#xD;
      two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided&#xD;
      significance level will have 92% power to detect the difference between a normotensive OSA&#xD;
      rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group&#xD;
      is 50. There are no risks associated with the use of the home sleep test device, but subjects&#xD;
      that have a severe latex allergy should not participate, as the device&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 16, 2017</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 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>Prevalence of OSA in pregnant women with chronic HTN</measure>
    <time_frame>20 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN</measure>
    <time_frame>20 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN</measure>
    <time_frame>20 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.</measure>
    <time_frame>20 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN</measure>
    <time_frame>20 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.</measure>
    <time_frame>20 months</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <condition>Pregnancy</condition>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Chronic Hypretension in Pregnancy</arm_group_label>
    <description>Pregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Normotensive in Pregnancy</arm_group_label>
    <description>Pregnant subjects between 10-20 weeks gestation with normal blood pressure, and not on any treatment for chronic hypertension and no history of chronic hypertension, and matched for body mass index (+/- 3 kg/m2) with the chronic hypertension group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>WP200U home sleep study device</intervention_name>
    <description>WP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time.</description>
    <arm_group_label>Chronic Hypretension in Pregnancy</arm_group_label>
    <arm_group_label>Normotensive in Pregnancy</arm_group_label>
    <other_name>WatchPAT</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The investigators will recruit 120 adult pregnant subjects between 10-20 weeks gestation&#xD;
        from Duke Hospital and clinics in Durham, NC over a 20-month period. They will be enrolled&#xD;
        into one of two groups: 1) chronic hypertension (on medication or hypertensive blood&#xD;
        pressures documented on two clinic visits); 2) normal blood pressure, and not on any&#xD;
        treatment for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2)&#xD;
        with the chronic HTN group. The two groups will be matched for BMI to control for the&#xD;
        effect of obesity on OSA diagnosis and cHTN.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant woman who are patients of:Duke Hospital, Duke Birthing Center (DBC), Duke&#xD;
             Perinatal Durham clinic, Inpatients will be recruited from the obstetric antepartum&#xD;
             service.&#xD;
&#xD;
          -  Gestational age 10 weeks, 0 days to 20 weeks, 6 days&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  They will be enrolled into one of two groups:-Chronic hypertension (on medication or&#xD;
             hypertensive blood pressures documented on two clinic visits (including prior to&#xD;
             pregnancy), -Normal blood pressure, and not on any treatment for chronic HTN and no&#xD;
             history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the chronic HTN group&#xD;
&#xD;
          -  The two groups will be matched for body mass index to control for the effect of&#xD;
             obesity on OSA diagnosis and HTN.&#xD;
&#xD;
          -  Subjects will be not be excluded if they have an established diagnosis of OSA that is&#xD;
             not currently being treated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Being treated for OSA&#xD;
&#xD;
          -  On chronic opioids&#xD;
&#xD;
          -  On alpha-blockers (which can interfere with the PAT signal)&#xD;
&#xD;
          -  Have secondary HTN&#xD;
&#xD;
          -  Unwilling to remove nail polish and/or shorten one nail (which can also interfere with&#xD;
             the PAT signal)&#xD;
&#xD;
          -  Have a severe allergy to latex&#xD;
&#xD;
          -  Do not speak English.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Limited to pregnant women</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jennifer Dominguez, MD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University Medical Center, Dept Anesthesiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>September 20, 2019</last_update_submitted>
  <last_update_submitted_qc>September 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sleep disordered breathing</keyword>
  <keyword>Obstructive sleep apnea</keyword>
  <keyword>Hypertension</keyword>
  <keyword>Pregnancy</keyword>
  <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>
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03230110
org study id: Pro00081272
nct id: NCT03230110
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this study is to identify whether pregnant women with chronic hypertension are
      at significantly higher risk of having undiagnosed OSA and should be routinely screened with
      home sleep tests. The investigators will recruit 120 pregnant subjects between 10-20 weeks
      gestation from the Duke High Risk Obstetrics Clinic over a 20-month period. They will be
      enrolled into one of two groups: 1) chronic hypertension (on medication or hypertensive blood
      pressures documented at 3 clinic visits); 2) normal blood pressure, and not on any treatment
      for chronic HTN and no history of chronic HTN, and matched for BMI (+/- 3 kg/m2) with the
      chronic HTN group. The two groups will be matched for BMI to control for the effect of
      obesity on OSA diagnosis and cHTN. The primary hypothesis, that OSA prevalence differs
      between patients with chronic HTN and normotensive controls, will be assessed with a
      two-group two-sided Fisher's exact test. A Fisher's exact test with a 0.05 two-sided
      significance level will have 92% power to detect the difference between a normotensive OSA
      rate of 0.10 and a chronic hypertensive OSA rate of 0.40 when the sample size in each group
      is 50. There are no risks associated with the use of the home sleep test device, but subjects
      that have a severe latex allergy should not participate, as the device
observational model: Case-Control
time perspective: Prospective
measure: Prevalence of OSA in pregnant women with chronic HTN
time frame: 20 months
measure: Prevalence of OSA in pregnant women who are normotensive and BMI-matched to women with chronic HTN
time frame: 20 months
measure: Apnea-hypopnea indices in pregnant women with untreated OSA and cHTN
time frame: 20 months
measure: Apnea-hypopnea indices in pregnant women with untreated OSA and normotensive.
time frame: 20 months
measure: Oxygen-desaturation indices in pregnant women with untreated OSA and cHTN
time frame: 20 months
measure: Oxygen-desaturation indices in pregnant women with untreated OSA and normotensive.
time frame: 20 months
arm group label: Chronic Hypretension in Pregnancy
description: Pregnant subjects between 10-20 weeks gestation with chronic hypertension (on medication or hypertensive blood pressures documented at 2 clinic visits)
arm group label: Normotensive in Pregnancy
description: Pregnant subjects between 10-20 weeks gestation with normal blood pressure, and not on any treatment for chronic hypertension and no history of chronic hypertension, and matched for body mass index (+/- 3 kg/m2) with the chronic hypertension group.
intervention type: Diagnostic Test
intervention name: WP200U home sleep study device
description: WP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time.
arm group label: Chronic Hypretension in Pregnancy
arm group label: Normotensive in Pregnancy
other name: WatchPAT
Serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Limited to pregnant women
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jennifer Dominguez, MD, MHS
role: Principal Investigator
affiliation: Duke University Medical Center, Dept Anesthesiology
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Hypertension
sharing ipd: No