<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/NCT04496843</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A01347-50</org_study_id>
    <nct_id>NCT04496843</nct_id>
  </id_info>
  <brief_title>Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device</brief_title>
  <acronym>VPASH</acronym>
  <official_title>Validation of the Diagnostic Performance of the Sleep Apnea Syndrome by the Withings HWA09 Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Withings</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Withings</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general&#xD;
      population. It aggravates morbidity and cardio-metabolic mortality and is responsible for&#xD;
      accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not&#xD;
      diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test&#xD;
      of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and&#xD;
      insufficient availability of these exams. It would therefore be useful to carry out a&#xD;
      screening test before directing the patient to a complete test.&#xD;
&#xD;
      Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula,&#xD;
      oximetry, heart rate) but they generally record only one night and remain intrusive enough to&#xD;
      perturb the sleep.&#xD;
&#xD;
      The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals:&#xD;
      movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the&#xD;
      present study is to validate the diagnostic performance of the Withings HWA09 for the&#xD;
      detection of SAS compared to PSG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects are patients having a prescription for a one-night polysomnographic consultation in&#xD;
      order to diagnose potential sleep disorders. The investigator will collect the consent before&#xD;
      including any patient in this study. The study last one night per patient, during which&#xD;
      saturation signal recordings and the sleep apnea detection will be made by the HWA09 watch,&#xD;
      in comparison to the polysomnography.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 16, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 5/h in PSG</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at apnea-hypopnea index (AHI) threshold value of 5/h in PSG.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 15/h in PSG</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 15/h in PSG.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 30/h in PSG</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 30/h in PSG.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and Specificity of the desaturation detected by Withings HWA09</measure>
    <time_frame>1 year</time_frame>
    <description>Sensitivity and specificity of the desaturation detection by Withings HWA09 compared to an oximeter with the Oxygen Desaturation Index (ODI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG</measure>
    <time_frame>1 year</time_frame>
    <description>Bias and mean absolute error (MAE)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the proportion of apnea events on the performance of Withings HWA09</measure>
    <time_frame>1 year</time_frame>
    <description>Bias and MAE for apnea index (AI) estimated by Withings HWA09 compared to PSG results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of the proportion of hypopnea events on the performance of Withings HWA09</measure>
    <time_frame>1 year</time_frame>
    <description>Bias and MAE for hypopnea index (HI) estimated by Withings HWA09 compared to PSG results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Influence of the position of the sleeper (supine vs prone/lateral decubitus position) on the error of the AHI predicted by Withings HWA09 compared with PSG</measure>
    <time_frame>1 year</time_frame>
    <description>Average difference of AHI between Withings HWA09 and the PSG in each position</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reliability of Withings HWA09</measure>
    <time_frame>1 year</time_frame>
    <description>Rate of unusable of lost nights</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">220</enrollment>
  <condition>Sleep Apnea</condition>
  <arm_group>
    <arm_group_label>Patients referred for an overnight in-lab PSG</arm_group_label>
    <description>Simultaneous assessment of SAS with Withings HWA09 Device and overnight PSG</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HWA09 Measurement</intervention_name>
    <description>Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.</description>
    <arm_group_label>Patients referred for an overnight in-lab PSG</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred for an in-lab polysomnography&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults, men and women, between 18 and 70 y/o&#xD;
&#xD;
          -  Patient addressed for a polysomnography because of a suspicion of sleep respiratory&#xD;
             disorders&#xD;
&#xD;
          -  Subject having expressed his/her consent to take part in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Recording under continuous positive pressure&#xD;
&#xD;
          -  Subject having refuse to give his/her consent&#xD;
&#xD;
          -  Vulnerable subjects according to regulation in force :&#xD;
&#xD;
          -  Pregnant, parturient or breastfeeding women&#xD;
&#xD;
          -  Subjects having a known allergy to one of the components of the sensor (silicon,&#xD;
             stainless steel, sapphire glass)&#xD;
&#xD;
          -  Subjects deprived of liberty by a court, medical or administrative order&#xD;
&#xD;
          -  Subjects legally protected or unable to express their non-opposition to take part in&#xD;
             the study&#xD;
&#xD;
          -  Subjects unable to express their consent due to linguistic or mental incapacities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Gabriel Roisman</last_name>
    <role>Principal Investigator</role>
    <affiliation>Antoine Béclère Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Delphine Ladarré, PhD</last_name>
    <phone>+33 6 75 12 23 80</phone>
    <email>delphine.ladarre@withings.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ruiyi Yang, PhD</last_name>
    <phone>+33 6 19 78 25 54</phone>
    <email>ruiyi.yang@withings.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>St Pierre Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Antoine Béclère Hospital</name>
      <address>
        <city>Clamart</city>
        <state>Ile-de-France</state>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriel Roisman</last_name>
      <phone>+ 33 1 45 37 48 19</phone>
      <email>gabriel.roisman@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04496843
org study id: 2019-A01347-50
nct id: NCT04496843
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Sleep Apnea Syndrome (SAS) is a common pathology affecting between 4 and 8% of the general
      population. It aggravates morbidity and cardio-metabolic mortality and is responsible for
      accidents related to vigilance disorders. It is estimated that 80%% of SAS cases are not
      diagnosed and therefore not treated. It is however impracticable to propose a diagnostic test
      of polygraphy (PG) or polysomnography (PSG) to every patient because of the cost and
      insufficient availability of these exams. It would therefore be useful to carry out a
      screening test before directing the patient to a complete test.

      Several simplified polygraph systems with 2 or 3 channels have been proposed (nasal cannula,
      oximetry, heart rate) but they generally record only one night and remain intrusive enough to
      perturb the sleep.

      The Withings HWA09 is a wrist-worn watch, which allows screening of SAS from four signals:
      movement, heart rate, breathing rate and blood oxygen saturation (SpO2). The objective of the
      present study is to validate the diagnostic performance of the Withings HWA09 for the
      detection of SAS compared to PSG.
Subjects are patients having a prescription for a one-night polysomnographic consultation in
      order to diagnose potential sleep disorders. The investigator will collect the consent before
      including any patient in this study. The study last one night per patient, during which
      saturation signal recordings and the sleep apnea detection will be made by the HWA09 watch,
      in comparison to the polysomnography.
observational model: Case-Control
time perspective: Prospective
measure: Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 5/h in PSG
time frame: 1 year
description: Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at apnea-hypopnea index (AHI) threshold value of 5/h in PSG.
measure: Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 15/h in PSG
time frame: 1 year
description: Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 15/h in PSG.
measure: Sensitivity and Specificity of Withings HWA09 at AHI threshold value of 30/h in PSG
time frame: 1 year
description: Sensitivity and specificity for SAS detection by Withings HWA09 compared to PSG at AHI threshold value of 30/h in PSG.
measure: Sensitivity and Specificity of the desaturation detected by Withings HWA09
time frame: 1 year
description: Sensitivity and specificity of the desaturation detection by Withings HWA09 compared to an oximeter with the Oxygen Desaturation Index (ODI)
measure: Accuracy of Withings HWA09 to estimate total sleep time (TST) given by PSG
time frame: 1 year
description: Bias and mean absolute error (MAE)
measure: Impact of the proportion of apnea events on the performance of Withings HWA09
time frame: 1 year
description: Bias and MAE for apnea index (AI) estimated by Withings HWA09 compared to PSG results
measure: Impact of the proportion of hypopnea events on the performance of Withings HWA09
time frame: 1 year
description: Bias and MAE for hypopnea index (HI) estimated by Withings HWA09 compared to PSG results
measure: Influence of the position of the sleeper (supine vs prone/lateral decubitus position) on the error of the AHI predicted by Withings HWA09 compared with PSG
time frame: 1 year
description: Average difference of AHI between Withings HWA09 and the PSG in each position
measure: Reliability of Withings HWA09
time frame: 1 year
description: Rate of unusable of lost nights
arm group label: Patients referred for an overnight in-lab PSG
description: Simultaneous assessment of SAS with Withings HWA09 Device and overnight PSG
intervention type: Diagnostic Test
intervention name: HWA09 Measurement
description: Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.
arm group label: Patients referred for an overnight in-lab PSG
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
last name: Gabriel Roisman
role: Principal Investigator
affiliation: Antoine Béclère Hospital
last name: Delphine Ladarré, PhD
phone: +33 6 75 12 23 80
email: delphine.ladarre@withings.com
last name: Ruiyi Yang, PhD
phone: +33 6 19 78 25 54
email: ruiyi.yang@withings.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
country: Belgium
country: France
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea Syndromes
sharing ipd: No