<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/NCT01719224</url>
  </required_header>
  <id_info>
    <org_study_id>2011P001326</org_study_id>
    <nct_id>NCT01719224</nct_id>
  </id_info>
  <brief_title>Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention</brief_title>
  <official_title>Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases&#xD;
      the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore,&#xD;
      the investigators want to elucidate the anatomical and physiological risk factors that&#xD;
      contribute in the upper airway obstruction in post-partum patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After obtaining study consent, each patient underwent measurements of upper airway&#xD;
      cross-sectional area (CSA) during daytime within 48 h after delivery. The minimum upper&#xD;
      airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry;&#xD;
      Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.&#xD;
      This method has been previously used and validated in pregnant women.&#xD;
&#xD;
      In the patients who further gave consent for the sleep study, polysomnography (PSG) was&#xD;
      performed throughout the entire study night. Within a crossover design, patients were&#xD;
      randomly assigned to receive first either nonelevated or 45° elevated upper body position.&#xD;
      Position was changed after 3.5 h by a member of the team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep</measure>
    <time_frame>48 hours after delivery</time_frame>
    <description>We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients</measure>
    <time_frame>48 hours after delivery</time_frame>
    <description>Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Sleep Disordered Breathing</condition>
  <condition>Upper Airway Collapsibility</condition>
  <condition>Upper Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>Elevated body position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>supine body position</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>elevated body position</intervention_name>
    <description>45 degrees elevated upper body position</description>
    <arm_group_label>Elevated body position</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>supine body position</intervention_name>
    <description>non-elevated upper body position</description>
    <arm_group_label>supine body position</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Postpartum mothers within 48 hours of delivery in a major academic teaching hospital.&#xD;
&#xD;
          2. Age over 18 years.&#xD;
&#xD;
          3. Admitted to the Massachusetts General Hospital OB service for the delivery.&#xD;
&#xD;
          4. Interventions will be randomly assigned to the patients enrolled in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age under 18 years.&#xD;
&#xD;
          2. History of pre-existing pulmonary and cardiac diseases, including bronchial asthma,&#xD;
             cystic fibrosis, chronic obstructive lung disease, neck and chest tumors (thyroid,&#xD;
             mediastinal, etc.), irradiation to the neck and/or chest, and congenital airway&#xD;
             deformities, other critically-ill conditions.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthias Eikermann, MD, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital Department of Anesthesia, Critical Care and Pain Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>October 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <results_first_submitted>March 21, 2017</results_first_submitted>
  <results_first_submitted_qc>May 10, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 15, 2017</results_first_posted>
  <last_update_submitted>May 10, 2017</last_update_submitted>
  <last_update_submitted_qc>May 10, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Matthias Eikermann</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</mesh_term>
    <mesh_term>Sleep Apnea Syndromes</mesh_term>
    <mesh_term>Airway Obstruction</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Women during the first 48 h after delivery were included. Patients with a history of preexisting pulmonary and cardiac diseases or neck and chest tumors, as well as patients with a history of irradiation to the neck and/or chest or congenital airway deformities were not included in the study</recruitment_details>
      <pre_assignment_details>55 patients enrolled in the study and all of them successfully completed acoustic pharyngometry during wakefulness. 36 of 55 participants were randomized to receive one of the two sleeping positions first. Of those not randomized, 19 declined to participate in the overnight PSG recording.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Experimental: Elevated Position, Then Non-Elevated Position</title>
          <description>In the beginning of the study night, participants were placed in a sleeping position at 45 degrees upper body elevation. After 3.5h, a study member changed the patients bed to a non-elevated position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night.</description>
        </group>
        <group group_id="P2">
          <title>Experimental: Non-Elevated Position, Then Elevated Position</title>
          <description>In the beginning of the study night, participants were placed in a non-elevated sleeping position. After 3.5h, a study member changed the patients bed to a 45 degrees upper body position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Intervention 1: Sleeping Position 1</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Intervention 2: Position Change(At 3.5h)</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>55 patients enrolled in the study and all of them successfully completed acoustic pharyngometry during wakefulness. 36 of 55 participants were randomized to receive one of the two sleeping positions first. Of those not randomized, 19 declined to participate in the overnight PSG recording.</population>
      <group_list>
        <group group_id="B1">
          <title>Total Study Population (N=55)</title>
          <description>Fifty-five patients were enrolled within 48 hours after delivery from two newborn family units at MGH hospital.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.13" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI prior to pregnancy</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.82" spread="6.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI end of pregnancy</title>
          <units>kg/m²</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.84" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Delivery method: C-Section</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep</title>
        <description>We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.</description>
        <time_frame>48 hours after delivery</time_frame>
        <population>55 women (older than 18 years) were recruited within 48 h after delivery. Polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.</population>
        <group_list>
          <group group_id="O1">
            <title>Elevated Upper Body Position</title>
            <description>We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.&#xD;
elevated body position: 45 degrees elevated upper body position</description>
          </group>
          <group group_id="O2">
            <title>Non-elevated Upper Body Position</title>
            <description>We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.&#xD;
Supine body position: non-elevated upper body position</description>
          </group>
        </group_list>
        <measure>
          <title>Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep</title>
          <description>We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.</description>
          <population>55 women (older than 18 years) were recruited within 48 h after delivery. Polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.</population>
          <units>Apneas and hypopneas per hour of sleep</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="34"/>
                <count group_id="O2" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.5" spread="1.4"/>
                    <measurement group_id="O2" value="7.7" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients</title>
        <description>Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.</description>
        <time_frame>48 hours after delivery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Sitting Position</title>
            <description>Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a sitting position</description>
          </group>
          <group group_id="O2">
            <title>Non-elevated Position</title>
            <description>Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) position.</description>
          </group>
          <group group_id="O3">
            <title>45 Degree Elevation</title>
            <description>Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) position.</description>
          </group>
        </group_list>
        <measure>
          <title>Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients</title>
          <description>Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.</description>
          <units>cm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.54" spread="0.1"/>
                    <measurement group_id="O2" value="1.35" spread="0.1"/>
                    <measurement group_id="O3" value="1.46" spread="0.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed</desc>
      <group_list>
        <group group_id="E1">
          <title>Elevated Body Position</title>
          <description>We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.&#xD;
elevated body position: 45 degrees elevated upper body position</description>
        </group>
        <group group_id="E2">
          <title>Supine Body Position</title>
          <description>We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.&#xD;
supine body position: non-elevated upper body position</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations include the fact that we report single-center-data and the inability draw conclusions on long-term outcome due to cross-over study-design.&#xD;
No direct implications on sleep-apnea during pregnancy.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Matthias Eikermann, MD, PhD</name_or_title>
      <organization>Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital</organization>
      <phone>617-643-7735</phone>
      <email>meikermann@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01719224
org study id: 2011P001326
nct id: NCT01719224
lead sponsor: 
has dmc: Yes
The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases
      the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore,
      the investigators want to elucidate the anatomical and physiological risk factors that
      contribute in the upper airway obstruction in post-partum patients.
After obtaining study consent, each patient underwent measurements of upper airway
      cross-sectional area (CSA) during daytime within 48 h after delivery. The minimum upper
      airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry;
      Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.
      This method has been previously used and validated in pregnant women.

      In the patients who further gave consent for the sleep study, polysomnography (PSG) was
      performed throughout the entire study night. Within a crossover design, patients were
      randomly assigned to receive first either nonelevated or 45° elevated upper body position.
      Position was changed after 3.5 h by a member of the team.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep
time frame: 48 hours after delivery
description: We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.
measure: Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients
time frame: 48 hours after delivery
description: Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position.
arm group label: Elevated body position
arm group type: Active Comparator
description: We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.
arm group label: supine body position
arm group type: Active Comparator
description: We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.
intervention type: Procedure
intervention name: elevated body position
description: 45 degrees elevated upper body position
arm group label: Elevated body position
intervention type: Procedure
intervention name: supine body position
description: non-elevated upper body position
arm group label: supine body position
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthias Eikermann, MD, Ph.D
role: Principal Investigator
affiliation: Massachusetts General Hospital Department of Anesthesia, Critical Care and Pain Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Matthias Eikermann
investigator title: Associate Professor
mesh term: Respiratory Aspiration
mesh term: Sleep Apnea Syndromes
mesh term: Airway Obstruction
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations include the fact that we report single-center-data and the inability draw conclusions on long-term outcome due to cross-over study-design.
No direct implications on sleep-apnea during pregnancy.
point of contact: 