<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/NCT02245659</url>
  </required_header>
  <id_info>
    <org_study_id>RN-326488</org_study_id>
    <nct_id>NCT02245659</nct_id>
  </id_info>
  <brief_title>Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial</brief_title>
  <official_title>The Effect of Continuous Positive Airway Pressure (CPAP) Treatment on Glycemic Control in Gestational Diabetes: A Pilot Randomized-Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McGill University Health Centre/Research Institute of the McGill University Health Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in&#xD;
      pregnant patients with sleep-disordered breathing and gestational diabetes&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during&#xD;
      pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing&#xD;
      (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and&#xD;
      intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation&#xD;
      have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy,&#xD;
      SDB may represent a novel risk factor for GDM, as suggested by recent observational studies.&#xD;
      No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet&#xD;
      been published.&#xD;
&#xD;
      General Objective: To perform a pilot study to assess the feasibility of conducting a&#xD;
      randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the&#xD;
      effects of SDB treatment on maternal-fetal outcomes in GDM.&#xD;
&#xD;
      Primary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM.&#xD;
      Secondary Aims: 2) To assess recruitment and retention rates over ~2 months of treatment 3)&#xD;
      To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal&#xD;
      glucose levels to determine sample size calculations for a future large-scale multi-site&#xD;
      randomized-controlled trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Average nightly hours of CPAP use</measure>
    <time_frame>Up to 8 weeks</time_frame>
    <description>Calculated over the course of pregnancy, with objective measurement from CPAP device download. CPAP will be initiated at time of diagnosis of sleep apnea after GDM diagnosis, and up until delivery of the baby (expected duration of 6-8 weeks)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recruitment and retention rates in trial</measure>
    <time_frame>At completion of study (prior to delivery of baby)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal glucose levels</measure>
    <time_frame>Throughout pregnancy until delivery</time_frame>
    <description>Continuous glucose monitoring and capillary blood glucose checks</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Pregnancy</condition>
  <condition>Sleep-disordered Breathing</condition>
  <condition>Gestational Diabetes</condition>
  <arm_group>
    <arm_group_label>CPAP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal dilator strip</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Control</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CPAP</intervention_name>
    <description>Continuous Positive Airway Pressure</description>
    <arm_group_label>CPAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Nasal dilator strip</intervention_name>
    <description>Nasal dilator strip to be worn nightly</description>
    <arm_group_label>Nasal dilator strip</arm_group_label>
    <other_name>Breathe-Right Strip</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women aged ≥ 18 y referred to the GDM clinic at the McGill University Health&#xD;
             Centre&#xD;
&#xD;
          -  &gt;20 weeks and &lt;34 weeks gestational age at time of recruitment&#xD;
&#xD;
          -  Gestational diabetes&#xD;
&#xD;
          -  Sleep-disordered breathing (SDB)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-gestational type 1 or type 2 diabetes&#xD;
&#xD;
          -  Multiple pregnancy&#xD;
&#xD;
          -  Conception by IVF&#xD;
&#xD;
          -  Prior treatment for SDB&#xD;
&#xD;
          -  severe medical illness&#xD;
&#xD;
          -  Severe SDB (AHI &gt;30) and Epworth Sleepiness Scale &gt;15 or oxygen desaturation index &gt;30&#xD;
             or sustained hypoxia &lt; 80%&#xD;
&#xD;
          -  Habitual sleep duration on average less than 5 hours/night (determined by actigraphy)&#xD;
&#xD;
          -  Cigarette smoking, alcohol consumption or illicit drug use&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>McGill University Health Centre</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A2Y3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>April 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2014</study_first_posted>
  <last_update_submitted>February 15, 2021</last_update_submitted>
  <last_update_submitted_qc>February 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McGill University Health Centre/Research Institute of the McGill University Health Centre</investigator_affiliation>
    <investigator_full_name>Sushmita Pamidi</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Diabetes, Gestational</mesh_term>
    <mesh_term>Diabetes Mellitus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>August 3, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02245659
org study id: RN-326488
nct id: NCT02245659
lead sponsor: 
has dmc: No
Clinical trial on effects of continuous positive airway pressure (CPAP) on glucose levels in
      pregnant patients with sleep-disordered breathing and gestational diabetes
Gestational diabetes (GDM), defined as glucose intolerance that is first recognized during
      pregnancy, is associated with adverse maternal and fetal outcomes. Sleep-disordered breathing
      (SDB) is characterized by breathing pauses during sleep leading to recurrent arousals and
      intermittent hypoxia. The resulting increases in sympathetic drive, cortisol and inflammation
      have been shown to lead to glucose dysregulation. In that SDB is prevalent during pregnancy,
      SDB may represent a novel risk factor for GDM, as suggested by recent observational studies.
      No interventional studies evaluating the effects of SDB treatment on GDM outcomes have yet
      been published.

      General Objective: To perform a pilot study to assess the feasibility of conducting a
      randomized-controlled trial using continuous positive airway pressure (CPAP) to evaluate the
      effects of SDB treatment on maternal-fetal outcomes in GDM.

      Primary Aim of Pilot Study: 1) To assess CPAP adherence in pregnant patients with GDM.
      Secondary Aims: 2) To assess recruitment and retention rates over ~2 months of treatment 3)
      To assess adequacy of nasal dilator strips as the control intervention 4) To measure maternal
      glucose levels to determine sample size calculations for a future large-scale multi-site
      randomized-controlled trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Average nightly hours of CPAP use
time frame: Up to 8 weeks
description: Calculated over the course of pregnancy, with objective measurement from CPAP device download. CPAP will be initiated at time of diagnosis of sleep apnea after GDM diagnosis, and up until delivery of the baby (expected duration of 6-8 weeks)
measure: Recruitment and retention rates in trial
time frame: At completion of study (prior to delivery of baby)
measure: Maternal glucose levels
time frame: Throughout pregnancy until delivery
description: Continuous glucose monitoring and capillary blood glucose checks
arm group label: CPAP
arm group type: Experimental
arm group label: Nasal dilator strip
arm group type: Other
description: Control
intervention type: Device
intervention name: CPAP
description: Continuous Positive Airway Pressure
arm group label: CPAP
intervention type: Other
intervention name: Nasal dilator strip
description: Nasal dilator strip to be worn nightly
arm group label: Nasal dilator strip
other name: Breathe-Right Strip
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
investigator full name: Sushmita Pamidi
investigator title: Assistant Professor of Medicine
mesh term: Sleep Apnea Syndromes
mesh term: Diabetes, Gestational
mesh term: Diabetes Mellitus
sharing ipd: No
submitted: August 3, 2023