<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/NCT03300037</url>
  </required_header>
  <id_info>
    <org_study_id>IAHO02</org_study_id>
    <nct_id>NCT03300037</nct_id>
  </id_info>
  <brief_title>HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor</brief_title>
  <acronym>HYPNOS</acronym>
  <official_title>HYpopnea and Apnea Detection and Treatment Performance of a New cardiOreSpiratory Holter Monitor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LivaNova</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>LivaNova</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>
      The HYPNOS study is an acute feasibility study to validate a new device for automatic&#xD;
      detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system&#xD;
      and it will perform the following tasks:&#xD;
&#xD;
        -  Detect apneas and hypopneas in real time, based on physiological signals acquired with a&#xD;
           cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))&#xD;
&#xD;
        -  Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of&#xD;
           mechanoreceptors of the skin close to the mastoid bone&#xD;
&#xD;
      The primary objective is to verify that the PASITHEA system is able to detect apneas and&#xD;
      hypopneas reliably.&#xD;
&#xD;
      The main secondary objective of the study is to assess the effect of kinesthetic stimulation&#xD;
      on reducing the number of sleep respiratory disorders.&#xD;
&#xD;
      Another objective of the study is to verify the safety of the PASITHEA system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2014</start_date>
  <completion_date type="Actual">April 16, 2015</completion_date>
  <primary_completion_date type="Actual">April 16, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Performance of real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events.</measure>
    <time_frame>1 night</time_frame>
    <description>During the night of the recording, the PASITHEA system and the PSG will be positioned in parallel. PSG-scored events will be matched with the output of the real-time detector: a true positive event is defined as an event detected less than 10 seconds before or within the duration of a PSG-annotated events. Apneas detected as hypopneas (and reciprocally) will be regarded as true positives. Sensitivity and positive predictive value will be calculated as per conventional definintion and the 9% confidence interval will be calculated using the Wilson score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011</measure>
    <time_frame>1 night</time_frame>
    <description>All adverse events will be recorded and assessed according to ISO 14155, rev 2011</description>
  </secondary_outcome>
  <enrollment type="Actual">46</enrollment>
  <condition>Sleep Apnea, Obstructive</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Kinesthetic stimulation</intervention_name>
    <description>The kinesthetic actuator is placed on the skin near the ear and emits vibrations.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Severe untreated obstructive SAS patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  above 18 years.&#xD;
&#xD;
          -  Patient with diagnosed severe obstructive sleep apnea syndrome (AHI &gt; 30/h and &gt; 80%&#xD;
             of obstructive events diagnosed on polysomnography or polygraphy performed less than 6&#xD;
             months ago )&#xD;
&#xD;
          -  Patient free from CPAP treatment or any other SAS treatment for at least 3 months&#xD;
&#xD;
          -  Patient with stable psychotropic medication since the diagnostic polysomnography or&#xD;
             polygraphy exam&#xD;
&#xD;
          -  Patient has signed the informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients sleeping less than 4 hours per night&#xD;
&#xD;
          -  Patients suffering from respiratory failure or periodic breathing (cheynes stokes)&#xD;
&#xD;
          -  Obese patient (BMI&gt;40kg/m2)&#xD;
&#xD;
          -  Diabetic patient with autonomic dysfunction&#xD;
&#xD;
          -  Vulnerable patient in accordance with article L1121-6 of CSP&#xD;
&#xD;
          -  Patient with progressive malignant pathology&#xD;
&#xD;
          -  Patient already involved in another clinical study that could affect the result of&#xD;
             this study&#xD;
&#xD;
          -  Pregnant patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Laboratoire du sommeil et d'EFCR; Hopital Michallon</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Montpellier</name>
      <address>
        <city>Montpellier</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rennes</name>
      <address>
        <city>Rennes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Tours</name>
      <address>
        <city>Tours</city>
        <zip>37 044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 3, 2017</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, Obstructive</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/NCT03300037
org study id: IAHO02
nct id: NCT03300037
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The HYPNOS study is an acute feasibility study to validate a new device for automatic
      detection and treatment of sleep apnea syndrome. The system is known as the PASITHEA system
      and it will perform the following tasks:

        -  Detect apneas and hypopneas in real time, based on physiological signals acquired with a
           cardiorespiratory holter (nasal air flow, heart rate and blood oxygen saturation (SaO2))

        -  Upon detection of apnea or hypopnea events, trigger kinesthetic stimulation of
           mechanoreceptors of the skin close to the mastoid bone

      The primary objective is to verify that the PASITHEA system is able to detect apneas and
      hypopneas reliably.

      The main secondary objective of the study is to assess the effect of kinesthetic stimulation
      on reducing the number of sleep respiratory disorders.

      Another objective of the study is to verify the safety of the PASITHEA system.
observational model: Cohort
time perspective: Prospective
measure: Performance of real-time detector of apnea and hypopnea: sensitivity and positive predictive value of the detector will be calculated when comparing automatically detected respiratory events to gold-standard PSG scoring of apnea/hypopnea events.
time frame: 1 night
description: During the night of the recording, the PASITHEA system and the PSG will be positioned in parallel. PSG-scored events will be matched with the output of the real-time detector: a true positive event is defined as an event detected less than 10 seconds before or within the duration of a PSG-annotated events. Apneas detected as hypopneas (and reciprocally) will be regarded as true positives. Sensitivity and positive predictive value will be calculated as per conventional definintion and the 9% confidence interval will be calculated using the Wilson score.
measure: Safety: number of adverse events with treatment ON or OFF as defined by ISO 14155, rev 2011
time frame: 1 night
description: All adverse events will be recorded and assessed according to ISO 14155, rev 2011
intervention type: Device
intervention name: Kinesthetic stimulation
description: The kinesthetic actuator is placed on the skin near the ear and emits vibrations.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Apnea
mesh term: Sleep Apnea, Obstructive
sharing ipd: No