<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/NCT03819023</url>
  </required_header>
  <id_info>
    <org_study_id>BR01</org_study_id>
    <nct_id>NCT03819023</nct_id>
  </id_info>
  <brief_title>Validation of RespiLife for Detection of Respiratory Suppression</brief_title>
  <official_title>Validation of RespiLife for Detection of Respiratory Suppression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioresp Technologies, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bioresp Technologies, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for&#xD;
      detection of respiratory rate and oxygen saturation in human subjects. This includes&#xD;
      evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and&#xD;
      oxygen saturation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for&#xD;
      detection of respiratory rate and oxygen saturation in human subjects. This includes&#xD;
      evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and&#xD;
      oxygen saturation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 20, 2018</start_date>
  <completion_date type="Actual">March 20, 2019</completion_date>
  <primary_completion_date type="Actual">March 2, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Evaluation of the device on people with normal and suppressed respiration</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>oxygen saturation percentage using photoplethysmography</measure>
    <time_frame>6 hours</time_frame>
    <description>The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Respiratory rate, breaths per minute using photoplethysmography</measure>
    <time_frame>6 hours</time_frame>
    <description>The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer and piezo electric and respiratory inductance plethysmography.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Respiration Disorders</condition>
  <arm_group>
    <arm_group_label>Normal subjects</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>respiratory suppressing drugs</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Respilife monitor</intervention_name>
    <description>Respilife monitor</description>
    <arm_group_label>respiratory suppressing drugs</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to understand and sign the informed consent&#xD;
&#xD;
          -  English speaking.&#xD;
&#xD;
          -  Able to comply with visits and follow ups included in this protocol&#xD;
&#xD;
          -  Ages 18-80 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Mentally or cognitively incompetent persons who cannot understand the procedures or&#xD;
             consent to the procedures.&#xD;
&#xD;
          -  An unstable medical condition, acute of chronic, that in the opinion of the&#xD;
             investigator puts the subject at health risks related this trial or interferes with&#xD;
             the clinical trial and data collection.&#xD;
&#xD;
          -  If a subject is not able to stop his CPAP or BiPAP therapy at least one week prior to&#xD;
             the sleep study night. This will be determined ty the principal investigator based on&#xD;
             her judgment.&#xD;
&#xD;
          -  Skin rash on the forehead.&#xD;
&#xD;
          -  A history of skin allergy to medical tape, even hypoallergenic tape.&#xD;
&#xD;
          -  A history of skin cancer on the forehead.&#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>
  <location>
    <facility>
      <name>Peninsula Sleep Center</name>
      <address>
        <city>Burlingame</city>
        <state>California</state>
        <zip>94010-3224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>April 3, 2019</last_update_submitted>
  <last_update_submitted_qc>April 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2019</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>Respiration Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>July 26, 2019</submitted>
    <returned>August 13, 2019</returned>
  </pending_results>
  <!-- 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/NCT03819023
org study id: BR01
nct id: NCT03819023
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for
      detection of respiratory rate and oxygen saturation in human subjects. This includes
      evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and
      oxygen saturation.
The purpose of this study is to evaluate the accuracy of RespiLife diagnostic technology for
      detection of respiratory rate and oxygen saturation in human subjects. This includes
      evaluation of Bioresp's RespiLife and its accuracy for measurement of respiratory rate and
      oxygen saturation.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Evaluation of the device on people with normal and suppressed respiration
primary purpose: Diagnostic
masking: None (Open Label)
measure: oxygen saturation percentage using photoplethysmography
time frame: 6 hours
description: The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer.
measure: Respiratory rate, breaths per minute using photoplethysmography
time frame: 6 hours
description: The Respilife algorithm will calculate the respiratory rate and oxygen saturation. The measurements will be compared and analyzed against the gold standard measurements using FDA -approved clinical tools, such as Nellcor oximeter and photoplethysmographer and piezo electric and respiratory inductance plethysmography.
arm group label: Normal subjects
arm group type: No Intervention
arm group label: respiratory suppressing drugs
arm group type: Active Comparator
intervention type: Diagnostic Test
intervention name: Respilife monitor
description: Respilife monitor
arm group label: respiratory suppressing drugs
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiration Disorders
sharing ipd: Undecided
submitted: July 26, 2019
returned: August 13, 2019