<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/NCT03748771</url>
  </required_header>
  <id_info>
    <org_study_id>UCSD 171173</org_study_id>
    <nct_id>NCT03748771</nct_id>
  </id_info>
  <brief_title>Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children</brief_title>
  <official_title>Validation of ApneaLink Air Home Sleep Testing in the Diagnosis of Obstructive Sleep Apnea in Adolescent Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be&#xD;
      tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of&#xD;
      obstructive sleep apnea (OSA) in adults..&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to&#xD;
      10% of obese children. The reported prevalence is likely underestimated due to the lack of&#xD;
      available laboratory polysomnography (PSG) testing for children. The high prevalence of OSA&#xD;
      coupled with an increase in obesity, a major risk factor of OSA in children, has resulted in&#xD;
      a significant strain for in laboratory PSG including children in the greater San Diego&#xD;
      county. Currently, HST in children is restricted based on the limited availability of HST&#xD;
      devices on children that have attained clearance by the US Food and Drug Administration&#xD;
      (FDA). In this study, the feasibility and the validity of the ApneaLink Air HST device will&#xD;
      be tested in children 12 years old and over. The ApneaLink Air HST device is cleared for the&#xD;
      diagnosis of OSA in adults and is frequently used amongst adult sleep medicine physicians.&#xD;
      Adolescent children will be recruited whose clinically indicated in laboratory PSG will be&#xD;
      performed at Rady Children's Hospital. Concurrent to their in-laboratory PSG, they will have&#xD;
      their sleep assessed using the ApneaLink Air device. Ten children will repeat the ApneaLink&#xD;
      Air HST at home following their sleep study within one week, and the remaining ten children&#xD;
      will have their ApneaLink Air HST performed within one week prior to their in laboratory&#xD;
      clinically indicated PSG.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">February 28, 2020</completion_date>
  <primary_completion_date type="Actual">February 28, 2020</primary_completion_date>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)</measure>
    <time_frame>Day 1</time_frame>
    <description>Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index)&#xD;
The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep.&#xD;
The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Day 1</time_frame>
    <description>Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: &quot;Do you prefer HST over PSG?&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Successful HST Evaluations</measure>
    <time_frame>Day 1</time_frame>
    <description>An unsuccesful HST or HST failure will be defined as:&#xD;
Loss of the nasal flow channel, or thoracic or abdominal sensor&#xD;
Recordings with less than 4h of artifact-free recording time&#xD;
Less than 4h of Sp02 signal</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <arm_group>
    <arm_group_label>ApneaLink Air</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Half of the participants will undergo HST no greater than one week prior to their in-laboratory PSG, while the other half will undergo HST no greater than one week following their in laboratory PSG. All participants will also undergo their HST concurrent to their in-laboratory PSG. The rational for splitting participants in these two groups is to equally distribute the effects of the first night evenly, in which the sleep architecture including reduced total rapid eye movement (REM) sleep time can vary during the first ever sleep study. As the HST will be compared to the in-lab PSG, we would like to evenly distribute this effect by having two groups of ten participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ApneaLink Air</intervention_name>
    <description>The ApneaLink Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients.&#xD;
ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.</description>
    <arm_group_label>ApneaLink Air</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with symptoms of OSA needing a sleep study&#xD;
&#xD;
          -  Patients between the ages of 12 and 17 years, inclusive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients less than 12 years old&#xD;
&#xD;
          -  Patients 18 years old or older&#xD;
&#xD;
          -  Children with syndromes or congenital disease including Down Syndrome, Prader-Willi&#xD;
             syndrome, children with craniofacial disorders, and finally children with congenital&#xD;
             heart disease or pulmonary hypertension&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rady Children's Hospital</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 12, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 21, 2018</study_first_posted>
  <results_first_submitted>May 20, 2021</results_first_submitted>
  <results_first_submitted_qc>October 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">November 15, 2021</results_first_posted>
  <last_update_submitted>October 17, 2021</last_update_submitted>
  <last_update_submitted_qc>October 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2021</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>October 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/71/NCT03748771/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>ApneaLink Air Cohort</title>
          <description>Patients underwent HST no greater than one week prior to or following their in-lab PSG.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>ApneaLink Air Cohort</title>
          <description>Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="20"/>
          </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="14.5" spread="1.72"/>
                  </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="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White Non-Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/square meters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)</title>
        <description>Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index)&#xD;
The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep.&#xD;
The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ApneaLink Air Cohort</title>
            <description>Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.</description>
          </group>
        </group_list>
        <measure>
          <title>Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)</title>
          <description>Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index)&#xD;
The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep.&#xD;
The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour</description>
          <units>events per hour</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AHI from HST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.2" spread="10.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ODI from HST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.9" spread="11.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AHI from ALT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.6" spread="21.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ODI from ALT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.9" spread="24.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AHI from PSG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.6" spread="35.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ODI from PSG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13.5" spread="26.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction</title>
        <description>Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: &quot;Do you prefer HST over PSG?&quot;</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ApneaLink Air Cohort</title>
            <description>Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: &quot;Do you prefer HST over PSG?&quot;</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="O1" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No Difference</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Successful HST Evaluations</title>
        <description>An unsuccesful HST or HST failure will be defined as:&#xD;
Loss of the nasal flow channel, or thoracic or abdominal sensor&#xD;
Recordings with less than 4h of artifact-free recording time&#xD;
Less than 4h of Sp02 signal</description>
        <time_frame>Day 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>ApneaLink Air Cohort</title>
            <description>Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Successful HST Evaluations</title>
          <description>An unsuccesful HST or HST failure will be defined as:&#xD;
Loss of the nasal flow channel, or thoracic or abdominal sensor&#xD;
Recordings with less than 4h of artifact-free recording time&#xD;
Less than 4h of Sp02 signal</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Successful HST</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Successful ALT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was collected for the duration of the study. For each patient this began from when they were enrolled in the study, and was completed when they finished all study activities including the home sleep test. The duration of each patients enrollment in the study was &lt;7 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>ApneaLink Air Cohort</title>
          <description>Patients underwent HST (home sleep apnea testing) no greater than one week prior to or following their in-lab PSG.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</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="20"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Rakesh Bhattacharjee</name_or_title>
      <organization>University of California San Diego</organization>
      <phone>858-966-5846</phone>
      <email>rlbhattacharjee@ucsd.edu</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/NCT03748771
org study id: UCSD 171173
nct id: NCT03748771
lead sponsor: 
has dmc: No
is unapproved device: Yes
The feasibility and the validity of the ApneaLink Air home sleep testing (HST) device will be
      tested in adolescent children. The ApneaLink Air HST device is cleared for the diagnosis of
      obstructive sleep apnea (OSA) in adults..
Obstructive sleep apnea is highly prevalent in children affecting 2-3% of children and up to
      10% of obese children. The reported prevalence is likely underestimated due to the lack of
      available laboratory polysomnography (PSG) testing for children. The high prevalence of OSA
      coupled with an increase in obesity, a major risk factor of OSA in children, has resulted in
      a significant strain for in laboratory PSG including children in the greater San Diego
      county. Currently, HST in children is restricted based on the limited availability of HST
      devices on children that have attained clearance by the US Food and Drug Administration
      (FDA). In this study, the feasibility and the validity of the ApneaLink Air HST device will
      be tested in children 12 years old and over. The ApneaLink Air HST device is cleared for the
      diagnosis of OSA in adults and is frequently used amongst adult sleep medicine physicians.
      Adolescent children will be recruited whose clinically indicated in laboratory PSG will be
      performed at Rady Children's Hospital. Concurrent to their in-laboratory PSG, they will have
      their sleep assessed using the ApneaLink Air device. Ten children will repeat the ApneaLink
      Air HST at home following their sleep study within one week, and the remaining ten children
      will have their ApneaLink Air HST performed within one week prior to their in laboratory
      clinically indicated PSG.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Accuracy of HST Compared to ALT (ApneaLink Lab Testing) and PSG (Polysomnography)
time frame: Day 1
description: Accuracy is measured by ODI (oxygen desaturation index) and AHI (apnea hypopnea index)
The ODI is defined as the number of episodes of oxygen desaturation per hour of sleep, with oxygen desaturation defined as a decrease in blood oxygen saturation (SpO2) to lower than 3% below baseline. The ODI is presented as an index to indicate the number of oxygen dips per hour of sleep.
The AHI indicates the number of apneas or hypopneas which occured during the sleep study, divided by the hours of sleep. The AHI is an Index which indicates how many events occurred each hour
measure: Patient Satisfaction
time frame: Day 1
description: Patient satisfaction with the HST and PSG procedures were determined by interview. Question read: "Do you prefer HST over PSG?"
measure: Number of Successful HST Evaluations
time frame: Day 1
description: An unsuccesful HST or HST failure will be defined as:
Loss of the nasal flow channel, or thoracic or abdominal sensor
Recordings with less than 4h of artifact-free recording time
Less than 4h of Sp02 signal
arm group label: ApneaLink Air
arm group type: Experimental
description: Half of the participants will undergo HST no greater than one week prior to their in-laboratory PSG, while the other half will undergo HST no greater than one week following their in laboratory PSG. All participants will also undergo their HST concurrent to their in-laboratory PSG. The rational for splitting participants in these two groups is to equally distribute the effects of the first night evenly, in which the sleep architecture including reduced total rapid eye movement (REM) sleep time can vary during the first ever sleep study. As the HST will be compared to the in-lab PSG, we would like to evenly distribute this effect by having two groups of ten participants.
intervention type: Device
intervention name: ApneaLink Air
description: The ApneaLink Air device is indicated for use by Health Care Professionals (HCP), where it may aid in the diagnosis of sleep disordered breathing for adult patients.
ApneaLink Air records the following data: patient respiratory nasal airflow, snoring, blood oxygen saturation, pulse and respiratory effort during sleep. The device uses these recordings to produce a report for the HCP that may aid in the diagnosis of sleep disordered breathing or for further clinical investigation. The device is intended for home and hospital use under the direction of a HCP.
arm group label: ApneaLink Air
criteria: 
gender: All
minimum age: 12 Years
maximum age: 17 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 