<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/NCT02967367</url>
  </required_header>
  <id_info>
    <org_study_id>AK/15-06-67/4522</org_study_id>
    <nct_id>NCT02967367</nct_id>
  </id_info>
  <brief_title>Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome</brief_title>
  <official_title>Reliability of Consumer Sleep Trackers in Patients Suffering From Obstructive Sleep Apnea Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Saint Pierre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Saint Pierre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During last years, numerous sleep trackers have been commercialized. They are intended to&#xD;
      give indications about sleep quality/duration in order to give people an internet-based&#xD;
      feedback about their own sleep.&#xD;
&#xD;
      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used&#xD;
      routinely to assess objective sleep quality/patterns. Their use is also validated to estimate&#xD;
      sleep in obstructive sleep apnea syndrome (OSA).&#xD;
&#xD;
      The purpose of the present study is to compare the accuracy of consumer-level sleep trackers&#xD;
      and validated tools to measure sleep in OSA patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During last years, numerous sleep trackers have been commercialized. They are working on&#xD;
      accelerometer-based technology. They are intended to give indications about sleep&#xD;
      quality/duration in order to give people an internet-based feedback about their own sleep..&#xD;
&#xD;
      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used&#xD;
      routinely to assess objective sleep quality/patterns. Their use is also validated to estimate&#xD;
      sleep in obstructive sleep apnea syndrome (OSA).&#xD;
&#xD;
      The purpose of our study is to compare the accuracy of consumer-level sleep trackers and&#xD;
      validated tools to measure sleep in OSA patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <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>Time in Bed</measure>
    <time_frame>one night (up to 600 minutes)</time_frame>
    <description>time spent in bed during the night (minutes)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sleep Efficiency</measure>
    <time_frame>one night (up to 600 minutes)</time_frame>
    <description>a percentage corresponding to total sleep time divided by time in bed</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Total Sleep Time</measure>
    <time_frame>one night (up to 600 minutes)</time_frame>
    <description>time spent sleeping during the night (minutes)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Deep Sleep</measure>
    <time_frame>one night (up to 600 minutes)</time_frame>
    <description>a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Light Sleep</measure>
    <time_frame>one night (up to 600 minutes)</time_frame>
    <description>a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Obstructive Sleep Apnea Syndrome</condition>
  <arm_group>
    <arm_group_label>Jawbone/Withings sleep trackers, Bodymedia Sensewear</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Jawbone sleep tracker</intervention_name>
    <description>During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
    <arm_group_label>Jawbone/Withings sleep trackers, Bodymedia Sensewear</arm_group_label>
    <other_name>accelerometer</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Withings sleep tracker</intervention_name>
    <description>During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
    <arm_group_label>Jawbone/Withings sleep trackers, Bodymedia Sensewear</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BodyMedia Sense Wear accelerometer</intervention_name>
    <description>During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
    <arm_group_label>Jawbone/Withings sleep trackers, Bodymedia Sensewear</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  high clinical suspicion of obstructive sleep apnea syndrome&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other associated sleep disorder&#xD;
&#xD;
          -  inability to sign informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Bruyneel, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Centre Hospitalier Universitaire Saint Pierre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHu Saint Pierre</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 5, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>February 7, 2019</results_first_submitted>
  <results_first_submitted_qc>March 12, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 24, 2020</results_first_posted>
  <last_update_submitted>March 12, 2020</last_update_submitted>
  <last_update_submitted_qc>March 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</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>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02967367/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 24, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/67/NCT02967367/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
          <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
          <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="53" spread="13"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="22"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time in Bed</title>
        <description>time spent in bed during the night (minutes)</description>
        <time_frame>one night (up to 600 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
            <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
          </group>
        </group_list>
        <measure>
          <title>Time in Bed</title>
          <description>time spent in bed during the night (minutes)</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="519" spread="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodymedia Sensewear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="446" spread="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jawbone sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="522" spread="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withings sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="524" spread="122"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Sleep Efficiency</title>
        <description>a percentage corresponding to total sleep time divided by time in bed</description>
        <time_frame>one night (up to 600 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
            <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
          </group>
        </group_list>
        <measure>
          <title>Sleep Efficiency</title>
          <description>a percentage corresponding to total sleep time divided by time in bed</description>
          <units>percentage of time in bed</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67" spread="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodymedia Sensewear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="80" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jawbone sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withings sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Total Sleep Time</title>
        <description>time spent sleeping during the night (minutes)</description>
        <time_frame>one night (up to 600 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
            <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
          </group>
        </group_list>
        <measure>
          <title>Total Sleep Time</title>
          <description>time spent sleeping during the night (minutes)</description>
          <units>min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="344" spread="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bodymedia Sensewear</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="358" spread="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jawbone sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="407" spread="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withings sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="431" spread="68"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Deep Sleep</title>
        <description>a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time</description>
        <time_frame>one night (up to 600 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
            <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
          </group>
        </group_list>
        <measure>
          <title>Deep Sleep</title>
          <description>a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time</description>
          <units>a percentage of total sleep time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="83" spread="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jawbone sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="243" spread="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withings sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="192" spread="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Light Sleep</title>
        <description>a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time</description>
        <time_frame>one night (up to 600 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
            <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</description>
          </group>
        </group_list>
        <measure>
          <title>Light Sleep</title>
          <description>a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time</description>
          <units>a percentage of total sleep time</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>PSG</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="190" spread="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Jawbone sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="163" spread="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Withings sleep tracker</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="239" spread="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>one night, up to 600 minutes</time_frame>
      <desc>22 participants were at risk for any adverse events, as usually described</desc>
      <group_list>
        <group group_id="E1">
          <title>Jawbone/Withings Sleep Trackers, Bodymedia Sensewear</title>
          <description>2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients&#xD;
Jawbone sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
Withings sleep tracker: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient&#xD;
BodyMedia Sense Wear accelerometer: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient</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="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
              </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="22"/>
              </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>Pr. Marie Bruyneel</name_or_title>
      <organization>CHU Saint-pierre</organization>
      <phone>00325354219</phone>
      <email>marie_bruyneel@stpierre-bru.be</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/NCT02967367
org study id: AK/15-06-67/4522
nct id: NCT02967367
lead sponsor: 
has dmc: No
During last years, numerous sleep trackers have been commercialized. They are intended to
      give indications about sleep quality/duration in order to give people an internet-based
      feedback about their own sleep.

      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used
      routinely to assess objective sleep quality/patterns. Their use is also validated to estimate
      sleep in obstructive sleep apnea syndrome (OSA).

      The purpose of the present study is to compare the accuracy of consumer-level sleep trackers
      and validated tools to measure sleep in OSA patients.
During last years, numerous sleep trackers have been commercialized. They are working on
      accelerometer-based technology. They are intended to give indications about sleep
      quality/duration in order to give people an internet-based feedback about their own sleep..

      For clinical and research purposes, tri-axial accelerometers/multi-sensors devices are used
      routinely to assess objective sleep quality/patterns. Their use is also validated to estimate
      sleep in obstructive sleep apnea syndrome (OSA).

      The purpose of our study is to compare the accuracy of consumer-level sleep trackers and
      validated tools to measure sleep in OSA patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Time in Bed
time frame: one night (up to 600 minutes)
description: time spent in bed during the night (minutes)
measure: Sleep Efficiency
time frame: one night (up to 600 minutes)
description: a percentage corresponding to total sleep time divided by time in bed
measure: Total Sleep Time
time frame: one night (up to 600 minutes)
description: time spent sleeping during the night (minutes)
measure: Deep Sleep
time frame: one night (up to 600 minutes)
description: a percentage corresponding to sleep time spent in deep sleep (stage N3 on polysomnography) divided by total sleep time
measure: Light Sleep
time frame: one night (up to 600 minutes)
description: a percentage corresponding to sleep time spent in light sleep (stage N1 and N2 on polysomnography) divided by total sleep time
arm group label: Jawbone/Withings sleep trackers, Bodymedia Sensewear
arm group type: Experimental
description: 2 types of Consumer sleep trackers, including Jawbone and Withings, and one research actigraph (Bodymedia Sensewear) are added to classical polysomnography in order to assess their accuracy to measure sleep parameters in obstructive sleep apnea patients
intervention type: Device
intervention name: Jawbone sleep tracker
description: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
arm group label: Jawbone/Withings sleep trackers, Bodymedia Sensewear
other name: accelerometer
intervention type: Device
intervention name: Withings sleep tracker
description: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
arm group label: Jawbone/Withings sleep trackers, Bodymedia Sensewear
intervention type: Device
intervention name: BodyMedia Sense Wear accelerometer
description: During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
arm group label: Jawbone/Withings sleep trackers, Bodymedia Sensewear
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Marie Bruyneel, MD PhD
role: Principal Investigator
affiliation: Centre Hospitalier Universitaire Saint Pierre
facility: 
country: Belgium
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
mesh term: Sleep Apnea, Obstructive
mesh term: Syndrome
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 