<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/NCT03785847</url>
  </required_header>
  <id_info>
    <org_study_id>VCS-008</org_study_id>
    <nct_id>NCT03785847</nct_id>
  </id_info>
  <brief_title>Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children</brief_title>
  <official_title>Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Revenio Research</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tampere University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study includes a comprehensive health examination with focus on respiratory health and&#xD;
      the TBFV recordings using impedance pneumography (Ventica®) during sleep at night in healthy&#xD;
      children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Impedance pneumograpy results in healthy children to generate normal values and to stude the&#xD;
      effect of age and gender&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">September 17, 2019</completion_date>
  <primary_completion_date type="Actual">September 17, 2019</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Ventica measurement</measure>
    <time_frame>overnight measurement</time_frame>
    <description>level of overnight tidal breathing flow volume variation</description>
  </primary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Respiration Disorders</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ventica</intervention_name>
    <description>Impedance pneumography measurement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Sample of 40 healthy children aged 12 - 71 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 12 months-71 months, both sexes&#xD;
&#xD;
          -  Healthy at the time of inclusion&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preterm birth&#xD;
&#xD;
          -  Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness&#xD;
&#xD;
          -  Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or&#xD;
             sleep disordered breathing&#xD;
&#xD;
          -  Acute respiratory infection or hospitalization because of an acute illness within 4&#xD;
             weeks prior to inclusion&#xD;
&#xD;
          -  Personal or family history of asthma&#xD;
&#xD;
          -  Recurrent wheezing without respiratory infection&#xD;
&#xD;
          -  Allergic rhinitis, chronic rhinosinusitis, or other chronic respiratory disorders&#xD;
&#xD;
          -  Atopic dermatitis&#xD;
&#xD;
          -  Diagnosed allergic sensitization&#xD;
&#xD;
          -  Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion&#xD;
&#xD;
          -  Any major chronic illness as judged by the investigators&#xD;
&#xD;
          -  Implanted or external active medical devices such as pacemakers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Months</minimum_age>
    <maximum_age>71 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jussi Karjalainen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>TAYS Allergiakeskus</name>
      <address>
        <city>Tampere</city>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <reference>
    <citation>Seppa VP, Hyttinen J, Viik J. A method for suppressing cardiogenic oscillations in impedance pneumography. Physiol Meas. 2011 Mar;32(3):337-45. doi: 10.1088/0967-3334/32/3/005. Epub 2011 Feb 14.</citation>
    <PMID>21321385</PMID>
  </reference>
  <reference>
    <citation>Seppa VP, Hyttinen J, Uitto M, Chrapek W, Viik J. Novel electrode configuration for highly linear impedance pneumography. Biomed Tech (Berl). 2013 Feb;58(1):35-8. doi: 10.1515/bmt-2012-0068.</citation>
    <PMID>23348215</PMID>
  </reference>
  <reference>
    <citation>Seppa VP, Pelkonen AS, Kotaniemi-Syrjanen A, Makela MJ, Viik J, Malmberg LP. Tidal breathing flow measurement in awake young children by using impedance pneumography. J Appl Physiol (1985). 2013 Dec;115(11):1725-31. doi: 10.1152/japplphysiol.00657.2013. Epub 2013 Oct 3.</citation>
    <PMID>24092693</PMID>
  </reference>
  <reference>
    <citation>Malmberg LP, Seppa VP, Kotaniemi-Syrjanen A, Malmstrom K, Kajosaari M, Pelkonen AS, Viik J, Makela MJ. Measurement of tidal breathing flows in infants using impedance pneumography. Eur Respir J. 2017 Feb 15;49(2):1600926. doi: 10.1183/13993003.00926-2016. Print 2017 Feb.</citation>
    <PMID>28182566</PMID>
  </reference>
  <reference>
    <citation>Seppa VP, Pelkonen AS, Kotaniemi-Syrjanen A, Viik J, Makela MJ, Malmberg LP. Tidal flow variability measured by impedance pneumography relates to childhood asthma risk. Eur Respir J. 2016 Jun;47(6):1687-96. doi: 10.1183/13993003.00989-2015. Epub 2016 Mar 17. Erratum In: Eur Respir J. 2016 Jul;48(1):285.</citation>
    <PMID>26989106</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>October 24, 2019</last_update_submitted>
  <last_update_submitted_qc>October 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tampere University Hospital</investigator_affiliation>
    <investigator_full_name>Jussi Karjalainen</investigator_full_name>
    <investigator_title>Head of Department, MD, PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiration Disorders</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/NCT03785847
org study id: VCS-008
nct id: NCT03785847
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study includes a comprehensive health examination with focus on respiratory health and
      the TBFV recordings using impedance pneumography (Ventica®) during sleep at night in healthy
      children.
Impedance pneumograpy results in healthy children to generate normal values and to stude the
      effect of age and gender
observational model: Cohort
time perspective: Cross-Sectional
measure: Ventica measurement
time frame: overnight measurement
description: level of overnight tidal breathing flow volume variation
intervention type: Diagnostic Test
intervention name: Ventica
description: Impedance pneumography measurement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Months
maximum age: 71 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Jussi Karjalainen, MD
role: Principal Investigator
affiliation: Tampere University Hospital
facility: 
country: Finland
citation: Seppa VP, Hyttinen J, Viik J. A method for suppressing cardiogenic oscillations in impedance pneumography. Physiol Meas. 2011 Mar;32(3):337-45. doi: 10.1088/0967-3334/32/3/005. Epub 2011 Feb 14.
PMID: 21321385
citation: Seppa VP, Hyttinen J, Uitto M, Chrapek W, Viik J. Novel electrode configuration for highly linear impedance pneumography. Biomed Tech (Berl). 2013 Feb;58(1):35-8. doi: 10.1515/bmt-2012-0068.
PMID: 23348215
citation: Seppa VP, Pelkonen AS, Kotaniemi-Syrjanen A, Makela MJ, Viik J, Malmberg LP. Tidal breathing flow measurement in awake young children by using impedance pneumography. J Appl Physiol (1985). 2013 Dec;115(11):1725-31. doi: 10.1152/japplphysiol.00657.2013. Epub 2013 Oct 3.
PMID: 24092693
citation: Malmberg LP, Seppa VP, Kotaniemi-Syrjanen A, Malmstrom K, Kajosaari M, Pelkonen AS, Viik J, Makela MJ. Measurement of tidal breathing flows in infants using impedance pneumography. Eur Respir J. 2017 Feb 15;49(2):1600926. doi: 10.1183/13993003.00926-2016. Print 2017 Feb.
PMID: 28182566
citation: Seppa VP, Pelkonen AS, Kotaniemi-Syrjanen A, Viik J, Makela MJ, Malmberg LP. Tidal flow variability measured by impedance pneumography relates to childhood asthma risk. Eur Respir J. 2016 Jun;47(6):1687-96. doi: 10.1183/13993003.00989-2015. Epub 2016 Mar 17. Erratum In: Eur Respir J. 2016 Jul;48(1):285.
PMID: 26989106
responsible party type: Principal Investigator
investigator affiliation: Tampere University Hospital
investigator full name: Jussi Karjalainen
investigator title: Head of Department, MD, PhD
mesh term: Respiration Disorders
sharing ipd: No