<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/NCT03269643</url>
  </required_header>
  <id_info>
    <org_study_id>RHEA EL30-2017-003</org_study_id>
    <nct_id>NCT03269643</nct_id>
  </id_info>
  <brief_title>Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients Patients</brief_title>
  <official_title>Pilot Clinical Evaluation of the RHEA Vital Sign Vigilance System in Hospital Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Darma Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medstar Health Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Darma 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>
      This study comparing both of the investigational device and reference device to gold standard&#xD;
      Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary&#xD;
      variables for the analysis of heart rate (HR) and respiratory rate (RR) are each the overall&#xD;
      mean root mean square difference (RMSD). Results of the investigational device and reference&#xD;
      device compared with the patient monitor are evaluated to see if there are equivalent. Motion&#xD;
      and bed exit accuracy will be evaluated by comparing with the manual observation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The testing will be conducted in three periods. In the Accuracy Tests (periods&#xD;
&#xD;
      1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being&#xD;
      compared with the Patient Monitor. The RHEA investigational device and reference device will&#xD;
      be used to monitor the same subject at different times, as the sensors of the two devices are&#xD;
      placed at a similar location of the bed. HR and RR will be recorded for all three devices.&#xD;
&#xD;
      The primary hypotheses for HR, are as follows:&#xD;
&#xD;
      Adults HO: μ = 3.25 vs. HA: μ &lt; 3.25, Children HO: μ = 3.5 vs. HA: μ &lt; 3.5,&#xD;
&#xD;
      The primary hypotheses for RR, are as follows:&#xD;
&#xD;
      Adults HO: μ = 2.25 vs. HA: μ &lt; 2.25, Children HO: μ = 2.5 vs. HA: μ &lt; 2.5, where μ&#xD;
      represents the population mean HR or RR. If the upper bound of the confidence interval is&#xD;
      less than the hypothesized value, the corresponding null hypothesis will be rejected.&#xD;
      Comparison of the performance of the two contact-free devices will be performed on the&#xD;
      recorded results via statistical analysis.&#xD;
&#xD;
      The hypothesis here is that the two devices have equivalent performance. The third test will&#xD;
      assess the ability of the RHEA device to accurately detect motion on or exit from the bed, as&#xD;
      compared to the manual observation. Motion and no motion accuracy will each be calculated&#xD;
      along with their respective two-sided 95% confidence intervals.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">November 24, 2017</completion_date>
  <primary_completion_date type="Actual">November 24, 2017</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>Crossover Assignment</intervention_model>
    <intervention_model_description>The RHEA device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of participants at the same time in Test 1. The reference device and patient monitor are used to monitor the hear rate and respiratory rate of the same participant at the same time at Test 2. The two tests results will be compared and evaluated the accuracy of the two devices. And the RHEA device is used alone to evaluate the accuracy of motion and no motion.</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate</measure>
    <time_frame>30 days</time_frame>
    <description>Record 20 valid pair heart rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the heart rate for the investigational device.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate</measure>
    <time_frame>30 days</time_frame>
    <description>Record 20 valid pair respiratory rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the respiratory rate for the investigational device.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Heart Rate t Test Comparison result between the Investigational Device and the Reference Device</measure>
    <time_frame>30 days</time_frame>
    <description>Record 20 valid heart rate displayed in the reference device and patient monitor at the same time every one minute.&#xD;
Calculate the t test results for heart rate for the reference device and the investigational device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory Rate t Test Comparison result between the Investigational Device and the Reference Device</measure>
    <time_frame>30 days</time_frame>
    <description>Record 20 valid respiratory rate displayed in the reference device and patient monitor at the same time every one minute. Calculate the t test results for respiratory rate for the reference device and the investigational device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motion Notification Accuracy(%)</measure>
    <time_frame>30 days</time_frame>
    <description>Record the time for each instructed movements from manual observation and time for movements notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bed Exit Notification Accuracy(%)</measure>
    <time_frame>30 days</time_frame>
    <description>Record the time for each instructed bed exit from manual observation and time for bed exit notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">15</enrollment>
  <condition>Vital Sign Monitoring</condition>
  <arm_group>
    <arm_group_label>Investigational Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Reference Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Investigational Group</intervention_name>
    <description>The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.</description>
    <arm_group_label>Investigational Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Reference group</intervention_name>
    <description>The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.</description>
    <arm_group_label>Reference Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or female, 18 years old and above.&#xD;
&#xD;
          2. Provide written informed consent.&#xD;
&#xD;
          3. Weight ranging from 20 to 150 kg inclusive.&#xD;
&#xD;
          4. Are located in a non-ICU hospital setting.&#xD;
&#xD;
          5. Agree to not eat during the testing period.&#xD;
&#xD;
          6. Agree to keep still.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Are connected to a device which may interfere with the device monitoring in this&#xD;
             study.&#xD;
&#xD;
          2. Are receiving any bedside care which may be incompatible with the study procedures.&#xD;
&#xD;
          3. Sleep apnea.&#xD;
&#xD;
          4. Pregnant or breastfeeding.&#xD;
&#xD;
          5. A likely need to receive or undergo a procedure during the testing period.&#xD;
&#xD;
          6. Cannot accept a nasal cannula, or have a monitor lead placed on the chest.&#xD;
&#xD;
          7. A significant medical condition in the judgement of the investigator, which may&#xD;
             compromise the study testing procedures.&#xD;
&#xD;
          8. Are wearing pacemaker or defibrillator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arrel Olano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medstar Health Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MedStar Health Research Institute, Inc.</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20770</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>August 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>April 12, 2019</last_update_submitted>
  <last_update_submitted_qc>April 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Vital Sign</keyword>
  <keyword>Vigilance System</keyword>
  <keyword>Heart Rate</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 7, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/43/NCT03269643/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03269643
org study id: RHEA EL30-2017-003
nct id: NCT03269643
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
This study comparing both of the investigational device and reference device to gold standard
      Patient Monitor of the accuracy of heart rate and respiratory rate monitoring. The primary
      variables for the analysis of heart rate (HR) and respiratory rate (RR) are each the overall
      mean root mean square difference (RMSD). Results of the investigational device and reference
      device compared with the patient monitor are evaluated to see if there are equivalent. Motion
      and bed exit accuracy will be evaluated by comparing with the manual observation.
The testing will be conducted in three periods. In the Accuracy Tests (periods

      1 and 2), one of the contact-free devices will be used to monitor the HR and RR, while being
      compared with the Patient Monitor. The RHEA investigational device and reference device will
      be used to monitor the same subject at different times, as the sensors of the two devices are
      placed at a similar location of the bed. HR and RR will be recorded for all three devices.

      The primary hypotheses for HR, are as follows:

      Adults HO: μ = 3.25 vs. HA: μ < 3.25, Children HO: μ = 3.5 vs. HA: μ < 3.5,

      The primary hypotheses for RR, are as follows:

      Adults HO: μ = 2.25 vs. HA: μ < 2.25, Children HO: μ = 2.5 vs. HA: μ < 2.5, where μ
      represents the population mean HR or RR. If the upper bound of the confidence interval is
      less than the hypothesized value, the corresponding null hypothesis will be rejected.
      Comparison of the performance of the two contact-free devices will be performed on the
      recorded results via statistical analysis.

      The hypothesis here is that the two devices have equivalent performance. The third test will
      assess the ability of the RHEA device to accurately detect motion on or exit from the bed, as
      compared to the manual observation. Motion and no motion accuracy will each be calculated
      along with their respective two-sided 95% confidence intervals.
allocation: Non-Randomized
intervention model: Crossover Assignment
intervention model description: The RHEA device and Patient Monitor are used to monitor the heart rate (HR) and respiratory rate (RR) of participants at the same time in Test 1. The reference device and patient monitor are used to monitor the hear rate and respiratory rate of the same participant at the same time at Test 2. The two tests results will be compared and evaluated the accuracy of the two devices. And the RHEA device is used alone to evaluate the accuracy of motion and no motion.
primary purpose: Screening
masking: None (Open Label)
measure: RMSD of Investigational Device's Heart Rate and Gold Standard Device's heart rate
time frame: 30 days
description: Record 20 valid pair heart rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the heart rate for the investigational device.
measure: RMSD of Investigational Device's Respiratory Rate and Gold Standard Device's Respiratory rate
time frame: 30 days
description: Record 20 valid pair respiratory rate displayed in the investigational device and patient monitor at the same time every one minutes.Calculate the root mean square difference(RMSD) of the respiratory rate for the investigational device.
measure: Heart Rate t Test Comparison result between the Investigational Device and the Reference Device
time frame: 30 days
description: Record 20 valid heart rate displayed in the reference device and patient monitor at the same time every one minute.
Calculate the t test results for heart rate for the reference device and the investigational device.
measure: Respiratory Rate t Test Comparison result between the Investigational Device and the Reference Device
time frame: 30 days
description: Record 20 valid respiratory rate displayed in the reference device and patient monitor at the same time every one minute. Calculate the t test results for respiratory rate for the reference device and the investigational device.
measure: Motion Notification Accuracy(%)
time frame: 30 days
description: Record the time for each instructed movements from manual observation and time for movements notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.
measure: Bed Exit Notification Accuracy(%)
time frame: 30 days
description: Record the time for each instructed bed exit from manual observation and time for bed exit notification shown in the investigational device. Calculate the times matched between these two to get the accuracy.
arm group label: Investigational Group
arm group type: Experimental
description: The RHEA device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
arm group label: Reference Group
arm group type: Active Comparator
description: The reference device and Patient Monitor Device are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
intervention type: Device
intervention name: Investigational Group
description: The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
arm group label: Investigational Group
intervention type: Device
intervention name: Reference group
description: The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
arm group label: Reference Group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Arrel Olano, MD
role: Principal Investigator
affiliation: Medstar Health Research Institute
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 