<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/NCT03753386</url>
  </required_header>
  <id_info>
    <org_study_id>2018-A01999-46</org_study_id>
    <nct_id>NCT03753386</nct_id>
  </id_info>
  <brief_title>Identification of Respiratory Profiles From Nasal Pressure Signals</brief_title>
  <acronym>IPR-SAINS</acronym>
  <official_title>Identification of Respiratory Profiles From Nasal Pressure Signals</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>SRETT</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil</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>
      Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by&#xD;
      smoking and associated with significant morbidity due to recurrent exacerbations or even&#xD;
      hospitalizations. It is one of the leading causes of death in rich countries.&#xD;
&#xD;
      Early detection of exacerbations of the disease is thus an economic and public health issue&#xD;
      in the world. Finding tools for automatic and early detection of an exacerbation is the&#xD;
      subject of the study. A continuous analysis of the frequency and shape of the patients'&#xD;
      breathing will be used.&#xD;
&#xD;
      As a first step in this study, investigators want to measure the frequency and shape of&#xD;
      breathing in healthy subjects as they execute standard activities. These activities include&#xD;
      resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and&#xD;
      recuperation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 16, 2019</start_date>
  <completion_date type="Actual">May 28, 2019</completion_date>
  <primary_completion_date type="Actual">May 16, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pressure</measure>
    <time_frame>10 Hz for 30 minutes</time_frame>
    <description>The monitoring device used records the nasal pressure from users at 10 Hz (one measure every 0.1 seconds).</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>Healthy subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects not presenting any pulmonary pathology that will follow the intervention Oxygen therapy simulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oxygen therapy simulation</intervention_name>
    <description>The intervention consists of reproducing oxygen therapy situations in healthy individuals by replacing oxygen bottles with bottles of air. A TeleOx® device will be placed on the circuit between the source and the nasal cannula for respiratory signals recording.&#xD;
The intervention will last 30 minutes, containing the following activities in the given order:&#xD;
rest (9 minutes);&#xD;
drinking water (1 minute);&#xD;
rest (1 minute);&#xD;
coughing (1 minute);&#xD;
rest (1 minute);&#xD;
reading aloud (1 minute);&#xD;
rest (1 minute);&#xD;
breathing by the mouth (1 minute);&#xD;
rest (1 minute);&#xD;
exercising (running) (3 minutes) and&#xD;
rest (10 minutes)&#xD;
Recordings will be retrieved after each test.</description>
    <arm_group_label>Healthy subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age of majority&#xD;
&#xD;
          -  Health volunteers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Age of minority&#xD;
&#xD;
          -  Protected adult&#xD;
&#xD;
          -  Person deprived of liberty&#xD;
&#xD;
          -  Respiratory pathology&#xD;
&#xD;
          -  Non affiliation to the health care system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jesus Gonzalez-Bermejo</last_name>
    <role>Principal Investigator</role>
    <affiliation>Groupe Hospitalier Pitié-Salpêtrière</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière</name>
      <address>
        <city>Paris</city>
        <zip>75013</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03753386
org study id: 2018-A01999-46
nct id: NCT03753386
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by
      smoking and associated with significant morbidity due to recurrent exacerbations or even
      hospitalizations. It is one of the leading causes of death in rich countries.

      Early detection of exacerbations of the disease is thus an economic and public health issue
      in the world. Finding tools for automatic and early detection of an exacerbation is the
      subject of the study. A continuous analysis of the frequency and shape of the patients'
      breathing will be used.

      As a first step in this study, investigators want to measure the frequency and shape of
      breathing in healthy subjects as they execute standard activities. These activities include
      resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and
      recuperation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Pressure
time frame: 10 Hz for 30 minutes
description: The monitoring device used records the nasal pressure from users at 10 Hz (one measure every 0.1 seconds).
arm group label: Healthy subjects
arm group type: Experimental
description: Subjects not presenting any pulmonary pathology that will follow the intervention Oxygen therapy simulation.
intervention type: Other
intervention name: Oxygen therapy simulation
description: The intervention consists of reproducing oxygen therapy situations in healthy individuals by replacing oxygen bottles with bottles of air. A TeleOx® device will be placed on the circuit between the source and the nasal cannula for respiratory signals recording.
The intervention will last 30 minutes, containing the following activities in the given order:
rest (9 minutes);
drinking water (1 minute);
rest (1 minute);
coughing (1 minute);
rest (1 minute);
reading aloud (1 minute);
rest (1 minute);
breathing by the mouth (1 minute);
rest (1 minute);
exercising (running) (3 minutes) and
rest (10 minutes)
Recordings will be retrieved after each test.
arm group label: Healthy subjects
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jesus Gonzalez-Bermejo
role: Principal Investigator
affiliation: Groupe Hospitalier Pitié-Salpêtrière
facility: 
country: France
responsible party type: Sponsor