<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/NCT04489186</url>
  </required_header>
  <id_info>
    <org_study_id>BF0001</org_study_id>
    <nct_id>NCT04489186</nct_id>
  </id_info>
  <brief_title>Continuous Cardiorespiratory Monitoring in Cystic Fibrosis</brief_title>
  <official_title>Piloting the Clinical Value of Wearable Cardiorespiratory Monitoring for People With Cystic Fibrosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Byteflies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospitals Cleveland Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Byteflies</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>
      Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is&#xD;
      characterized by pulmonary exacerbations (PEx). Wearable devices could provide a way for&#xD;
      long-term monitoring of disease progression and early signs of PEx to intervene as early as&#xD;
      possible, thereby improving long-term outcomes.&#xD;
&#xD;
      This in-hospital feasibility study will assess the ability of Byteflies Sensor Dots to&#xD;
      collect relevant cardiorespiratory data in people with CF and its compatibility with clinical&#xD;
      workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from&#xD;
      patients and healthcare providers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>The study is intended to evaluate the feasibility of a prototype wearable device for continuous cardiorespiratory monitoring in an inpatient and outpatient population with CF in preparation of a larger ambulatory clinical trial.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sensor Dot usability</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Assessed via user (healthcare professional and patient) surveys.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sensor Dot data quality</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Evaluated by visual examination of recorded electrocardiography (ECG), bioimpedance (bioZ), and accelerometry (ACC) data.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of calculated vital signs: heart rate</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Compare Sensor Dot heart rate (derived from ECG) in beats-per-minute against heart rate as measured by standard hospital equipment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of calculated vital signs: respiratory rate</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Compare Sensor Dot respiratory rate (derived from bioZ) in breaths-per-minute against respiratory rate as measured by standard hospital equipment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cough detection</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Assess if cough events can be derived from the wearable data, as compared to self-reported outcomes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Screen for candidate digital biomarkers in CF</measure>
    <time_frame>Up to 24 hours</time_frame>
    <description>Evaluate correlations between the recorded vital sign data (Sensor Dot) and CF severity scores derived from routine pulmonary function testing (PFT, based on Global Lung Function Initiative) and PEx.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Cystic Fibrosis</condition>
  <arm_group>
    <arm_group_label>All subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Wearable device</intervention_name>
    <description>Multimodal electrocardiography (ECG), bioimpedance (bioZ) and tri-axial accelerometry (ACC) monitoring with a single wearable device (Byteflies Sensor Dot) to derive heart rate, respiratory rate and actigraphy.</description>
    <arm_group_label>All subjects</arm_group_label>
    <other_name>Byteflies Sensor Dot</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old&#xD;
&#xD;
          -  Confirmed CF diagnosis as determined by a sweat chloride ≥ 60 mmol/L or the presence&#xD;
             of two known disease-causing mutations&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to provide written informed consent&#xD;
&#xD;
          -  A known allergy to any of the used medical adhesives&#xD;
&#xD;
          -  Presence of any type of electronic implanted medical device&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erica A Roesch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospitals Cleveland Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospitals Cleveland Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>wearable</keyword>
  <keyword>cardiorespiratory monitoring</keyword>
  <keyword>digital medicine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystic Fibrosis</mesh_term>
    <mesh_term>Fibrosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is a device feasibility study. The results will be shared via a publication.</ipd_description>
  </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/NCT04489186
org study id: BF0001
nct id: NCT04489186
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Cystic Fibrosis (CF) is a disease without a primary cure that requires lifelong care and is
      characterized by pulmonary exacerbations (PEx). Wearable devices could provide a way for
      long-term monitoring of disease progression and early signs of PEx to intervene as early as
      possible, thereby improving long-term outcomes.

      This in-hospital feasibility study will assess the ability of Byteflies Sensor Dots to
      collect relevant cardiorespiratory data in people with CF and its compatibility with clinical
      workflows, 2) identify candidate digital biomarkers, and 3) collect user feedback from
      patients and healthcare providers.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: The study is intended to evaluate the feasibility of a prototype wearable device for continuous cardiorespiratory monitoring in an inpatient and outpatient population with CF in preparation of a larger ambulatory clinical trial.
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Sensor Dot usability
time frame: Up to 24 hours
description: Assessed via user (healthcare professional and patient) surveys.
measure: Sensor Dot data quality
time frame: Up to 24 hours
description: Evaluated by visual examination of recorded electrocardiography (ECG), bioimpedance (bioZ), and accelerometry (ACC) data.
measure: Quality of calculated vital signs: heart rate
time frame: Up to 24 hours
description: Compare Sensor Dot heart rate (derived from ECG) in beats-per-minute against heart rate as measured by standard hospital equipment.
measure: Quality of calculated vital signs: respiratory rate
time frame: Up to 24 hours
description: Compare Sensor Dot respiratory rate (derived from bioZ) in breaths-per-minute against respiratory rate as measured by standard hospital equipment.
measure: Cough detection
time frame: Up to 24 hours
description: Assess if cough events can be derived from the wearable data, as compared to self-reported outcomes.
measure: Screen for candidate digital biomarkers in CF
time frame: Up to 24 hours
description: Evaluate correlations between the recorded vital sign data (Sensor Dot) and CF severity scores derived from routine pulmonary function testing (PFT, based on Global Lung Function Initiative) and PEx.
arm group label: All subjects
arm group type: Experimental
description: Single arm feasibility study with a wearable device intervention for cardiorespiratory and activity monitoring in subjects with cystic fibrosis.
intervention type: Device
intervention name: Wearable device
description: Multimodal electrocardiography (ECG), bioimpedance (bioZ) and tri-axial accelerometry (ACC) monitoring with a single wearable device (Byteflies Sensor Dot) to derive heart rate, respiratory rate and actigraphy.
arm group label: All subjects
other name: Byteflies Sensor Dot
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Erica A Roesch, MD
role: Principal Investigator
affiliation: University Hospitals Cleveland Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cystic Fibrosis
mesh term: Fibrosis
sharing ipd: No
ipd description: This is a device feasibility study. The results will be shared via a publication.