xml: <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/NCT05995613</url>
    </required_header>
    <id_info>
      <org_study_id>23-0812</org_study_id>
      <nct_id>NCT05995613</nct_id>
    </id_info>
    <brief_title>Evaluation of MABOS for Improved Pulse Oximeter Accuracy in Patients of Color</brief_title>
    <official_title>Evaluation of Wearable Melanin-Adjusted Blood Oxygen Sensor (MABOS) for Improved Accuracy in Patients of Color</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of North Carolina, Chapel Hill</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of North Carolina, Chapel Hill</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>
        Purpose: Investigate the safe wearability and basic functionality - epidermal melanin&#xD;
        concentration and blood oxygen estimation - of our developed device: Melanin-Adjusted Blood&#xD;
        Oxygen Sensor (MABOS)&#xD;
  &#xD;
        Participants: Healthy adults 18-65 years of age&#xD;
  &#xD;
        Procedures (methods): The investigators plan to enroll 12 healthy adult participants for the&#xD;
        study. The investigators aim to enroll 4 participants with skin tones associated with those&#xD;
        of African descent (Group A), 4 of East Asian descent (Group B), and 4 of European descent&#xD;
        (Group C). Additionally, the investigators aim to ensure half of group is male, and the other&#xD;
        half female. For the duration of the study, two wearable devices will be placed on the&#xD;
        participant: a Nonin PureSat pulse oximeter on a forefinger, and the novel wearable pulse&#xD;
        oximeter - MABOS - on the other forefinger. Prior to testing, an Ocean HR2 XR Spectrometer&#xD;
        will be used to assess the absorbance of three wavelengths of light - 410, 660, 940 nm - on&#xD;
        each patient's inner wrist. Following this, the two devices will be placed on the patient,&#xD;
        set up, and calibrated for 10 minutes. During the calibration period, MABOS will be used to&#xD;
        measure the same three wavelengths of light utilized by the Ocean HR2 XR Spectrometer (410,&#xD;
        660, and 940 nm). After the calibration period, all participants will be asked to perform the&#xD;
        following procedure 5 times as part of the testing period: a deep inhalation lasting no&#xD;
        longer than 10 seconds, followed by a slow exhalation lasting no longer than 30 seconds.&#xD;
        Between each trial, a five-minute break will be required. For the entire testing period, all&#xD;
        two devices will be continuously acquiring data. After this testing period, all two devices&#xD;
        will continue taking measurements until 90 minutes have elapsed. Skin integrity will be&#xD;
        examined before spectrometer use, after spectrometer use, after the calibration period, every&#xD;
        30 minutes after the start of the testing period, and after the testing period. During the&#xD;
        study, if the participants report any uncomfortable feeling and/or pain or if a change to the&#xD;
        skin at the site of device placement occurs, the measurements will be discontinued, and all&#xD;
        the devices placed on the participants will be removed. Questionnaires will be provided after&#xD;
        the study period and during follow-up visits approximately 48 hours and 96 hours post the&#xD;
        device testing visit for a proof-of-concept evaluation of the safe wearability.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 6, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Initial Device Safety Questionnaire</measure>
      <time_frame>10 minutes following the 90 minute testing period</time_frame>
      <description>Device safety and comfort will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is Strongly Disagree, and 5 is Strongly Agree. In the initial survey, the final 7 pertain to safety.&#xD;
  The Safety Sub-Score is determined by the latter 7 questions, making the score range from 7-35.&#xD;
  In this case, a higher number indicates a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Initial Device Comfort Questionnaire</measure>
      <time_frame>10 minutes following the 90 minute testing period</time_frame>
      <description>Device comfort will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is Strongly Disagree, and 5 is Strongly Agree. In the initial 19-question survey, the first 12 pertain to comfort.&#xD;
  The Comfort Sub-Score is determined by the first 12 questions, making the score range from 12-60.&#xD;
  In this case, a higher number indicates a better outcome.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Final Device Safety Questionnaire</measure>
      <time_frame>Two 10-minute sessions, one 2 days after the testing session, and one 4 days after the testing session</time_frame>
      <description>Device safety will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is &quot;Strongly Disagree&quot;, and 5 is &quot;Strongly Agree&quot; and scores range from 9-45, where a higher score indicates a better outcome. The following 9 questions are asked: &quot;I have noticed a change in skin condition since wearing the device&quot;; &quot;I have experienced a rash since wearing the device&quot;; &quot;I have experienced itching since wearing the device&quot;; &quot;I have experienced swelling since wearing the device&quot;; &quot;I have experienced a burning sensation since wearing the device&quot;; &quot;I have experienced vesicles blistering since wearing the device&quot;; &quot;I have experienced irregular warming of the skin since wearing the device&quot;; &quot;I have experienced a stinging sensation since wearing the device&quot;; and &quot;I have experienced a change in skin sensitivity since wearing the device.&quot;</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Epidermal Melanin Estimation</measure>
      <time_frame>First 10 minutes of the 90-minute testing session, during the calibration phase</time_frame>
      <description>Confirming the device's ability to differentiate skin tone using 3 wavelengths of light by comparison to a spectrometer.&#xD;
  Metric of Accuracy: Take the average 410 nm light absorption of each individual (an average of intensity of absorbance over time during the 10-minute calibration period), using both the spectrometer and the device. Find the regression line that best fits the 12 data points (where each data point is a paired observation of spectrometer and device 410-nm light absorption for a given participant). A positive R value, with an R-squared value &gt;80% for a simple linear regression, is considered a positive indication of a trend.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood Oxygen Level Estimation</measure>
      <time_frame>The latter 80 minutes of the testing period on the testing day, following the calibration period</time_frame>
      <description>Comparing the device's blood oxygen estimation to the FDA approved device to confirm accuracy.&#xD;
  Metric of Accuracy: Upon calibration of the device, each 60-second sample will constitute one 'estimate' of SpO2 (blood oxygen saturation). For the latter 80 minutes of the study, 80 samples will be derived. Each sample will be compared to what was recorded by the FDA-approved oximeter. The comparison will be accomplished by finding the regression line that best fits the cumulative 80-minute data from all 12 participants. A positive R value, with an R-squared value &gt;80% for a simple linear regression, is considered a positive indication of a trend.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Oxygen Saturation</condition>
    <arm_group>
      <arm_group_label>MABOS</arm_group_label>
      <description>Participants will have one FDA-approved pulse oximeter (Nonin PureSat) along with our novel pulse oximeter placed to acquire 90 minutes of biometric data</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MABOS</intervention_name>
      <description>The novel pulse oximeter (MABOS) will be placed to acquire two biometrics: blood oxygen saturation and epidermal melanin concentration.</description>
      <arm_group_label>MABOS</arm_group_label>
      <other_name>pulse oximeter</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Nonin PureSat</intervention_name>
      <description>An FDA approved pulse oximeter will be placed to acquire blood oxygen saturation.</description>
      <arm_group_label>MABOS</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals of African, East Asian, and European descent; equal proportions of male and&#xD;
          female individuals from each group.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male and females, with age between 18-65&#xD;
  &#xD;
            -  Health individuals (defined as: not known to suffer any significant illnesses relevant&#xD;
               to the proposed study, cited from The Textbook of Pharmaceutical Medicine)&#xD;
  &#xD;
            -  The investigators aim to enroll 4 participants with skin tones associated with those&#xD;
               of African descent, 4 of East Asian Descent, and 4 of European Descent. Additionally,&#xD;
               the investigators aim to ensure half of the group is male, the other half female.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant or lactating&#xD;
  &#xD;
            -  History of active (clinically significant) skin disorders that make skin vulnerable to&#xD;
               contact conventional electronic devices.&#xD;
  &#xD;
            -  History of allergic response to silicones or adhesives (such as 3M Tegaderm)&#xD;
  &#xD;
            -  Broken, damaged, or irritated skin or rashes near the sensor application sites&#xD;
  &#xD;
            -  Subjects who are physically or cognitively unable to perform activities of daily&#xD;
               living, assessed at the discretion of the investigator to ensure safe completion of&#xD;
               study tasks.&#xD;
  &#xD;
            -  Inability to perform the breathing tests - deep inhalation for 10 seconds, followed by&#xD;
               a slow exhalation no longer than 30 seconds.&#xD;
  &#xD;
            -  Presence of tattoos on fingers, hands, or forearms.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wubin Bai, Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>UNC Chapel Hill</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Wubin Bai, Ph.D.</last_name>
      <phone>617-949-9089</phone>
      <email>wbai@unc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Arjun Putcha, B.S.</last_name>
      <phone>704-954-4398</phone>
      <email>arjun22@live.unc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of North Carolina at Chapel Hill</name>
        <address>
          <city>Chapel Hill</city>
          <state>North Carolina</state>
          <zip>27514</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Arjun Putcha, B.S.</last_name>
        <phone>704-954-4398</phone>
        <email>arjun22@live.unc.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05995613
  org study id: 23-0812
  nct id: NCT05995613
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Purpose: Investigate the safe wearability and basic functionality - epidermal melanin
        concentration and blood oxygen estimation - of our developed device: Melanin-Adjusted Blood
        Oxygen Sensor (MABOS)
  
        Participants: Healthy adults 18-65 years of age
  
        Procedures (methods): The investigators plan to enroll 12 healthy adult participants for the
        study. The investigators aim to enroll 4 participants with skin tones associated with those
        of African descent (Group A), 4 of East Asian descent (Group B), and 4 of European descent
        (Group C). Additionally, the investigators aim to ensure half of group is male, and the other
        half female. For the duration of the study, two wearable devices will be placed on the
        participant: a Nonin PureSat pulse oximeter on a forefinger, and the novel wearable pulse
        oximeter - MABOS - on the other forefinger. Prior to testing, an Ocean HR2 XR Spectrometer
        will be used to assess the absorbance of three wavelengths of light - 410, 660, 940 nm - on
        each patient's inner wrist. Following this, the two devices will be placed on the patient,
        set up, and calibrated for 10 minutes. During the calibration period, MABOS will be used to
        measure the same three wavelengths of light utilized by the Ocean HR2 XR Spectrometer (410,
        660, and 940 nm). After the calibration period, all participants will be asked to perform the
        following procedure 5 times as part of the testing period: a deep inhalation lasting no
        longer than 10 seconds, followed by a slow exhalation lasting no longer than 30 seconds.
        Between each trial, a five-minute break will be required. For the entire testing period, all
        two devices will be continuously acquiring data. After this testing period, all two devices
        will continue taking measurements until 90 minutes have elapsed. Skin integrity will be
        examined before spectrometer use, after spectrometer use, after the calibration period, every
        30 minutes after the start of the testing period, and after the testing period. During the
        study, if the participants report any uncomfortable feeling and/or pain or if a change to the
        skin at the site of device placement occurs, the measurements will be discontinued, and all
        the devices placed on the participants will be removed. Questionnaires will be provided after
        the study period and during follow-up visits approximately 48 hours and 96 hours post the
        device testing visit for a proof-of-concept evaluation of the safe wearability.
  observational model: Cohort
  time perspective: Prospective
  measure: Initial Device Safety Questionnaire
  time frame: 10 minutes following the 90 minute testing period
  description: Device safety and comfort will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is Strongly Disagree, and 5 is Strongly Agree. In the initial survey, the final 7 pertain to safety.
  The Safety Sub-Score is determined by the latter 7 questions, making the score range from 7-35.
  In this case, a higher number indicates a better outcome.
  measure: Initial Device Comfort Questionnaire
  time frame: 10 minutes following the 90 minute testing period
  description: Device comfort will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is Strongly Disagree, and 5 is Strongly Agree. In the initial 19-question survey, the first 12 pertain to comfort.
  The Comfort Sub-Score is determined by the first 12 questions, making the score range from 12-60.
  In this case, a higher number indicates a better outcome.
  measure: Final Device Safety Questionnaire
  time frame: Two 10-minute sessions, one 2 days after the testing session, and one 4 days after the testing session
  description: Device safety will be assessed by qualitative survey. All questions are rated from 1-5, where 1 is "Strongly Disagree", and 5 is "Strongly Agree" and scores range from 9-45, where a higher score indicates a better outcome. The following 9 questions are asked: "I have noticed a change in skin condition since wearing the device"; "I have experienced a rash since wearing the device"; "I have experienced itching since wearing the device"; "I have experienced swelling since wearing the device"; "I have experienced a burning sensation since wearing the device"; "I have experienced vesicles blistering since wearing the device"; "I have experienced irregular warming of the skin since wearing the device"; "I have experienced a stinging sensation since wearing the device"; and "I have experienced a change in skin sensitivity since wearing the device."
  measure: Epidermal Melanin Estimation
  time frame: First 10 minutes of the 90-minute testing session, during the calibration phase
  description: Confirming the device's ability to differentiate skin tone using 3 wavelengths of light by comparison to a spectrometer.
  Metric of Accuracy: Take the average 410 nm light absorption of each individual (an average of intensity of absorbance over time during the 10-minute calibration period), using both the spectrometer and the device. Find the regression line that best fits the 12 data points (where each data point is a paired observation of spectrometer and device 410-nm light absorption for a given participant). A positive R value, with an R-squared value >80% for a simple linear regression, is considered a positive indication of a trend.
  measure: Blood Oxygen Level Estimation
  time frame: The latter 80 minutes of the testing period on the testing day, following the calibration period
  description: Comparing the device's blood oxygen estimation to the FDA approved device to confirm accuracy.
  Metric of Accuracy: Upon calibration of the device, each 60-second sample will constitute one 'estimate' of SpO2 (blood oxygen saturation). For the latter 80 minutes of the study, 80 samples will be derived. Each sample will be compared to what was recorded by the FDA-approved oximeter. The comparison will be accomplished by finding the regression line that best fits the cumulative 80-minute data from all 12 participants. A positive R value, with an R-squared value >80% for a simple linear regression, is considered a positive indication of a trend.
  arm group label: MABOS
  description: Participants will have one FDA-approved pulse oximeter (Nonin PureSat) along with our novel pulse oximeter placed to acquire 90 minutes of biometric data
  intervention type: Device
  intervention name: MABOS
  description: The novel pulse oximeter (MABOS) will be placed to acquire two biometrics: blood oxygen saturation and epidermal melanin concentration.
  arm group label: MABOS
  other name: pulse oximeter
  intervention type: Device
  intervention name: Nonin PureSat
  description: An FDA approved pulse oximeter will be placed to acquire blood oxygen saturation.
  arm group label: MABOS
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wubin Bai, Ph.D.
  role: Principal Investigator
  affiliation: UNC Chapel Hill
  last name: Wubin Bai, Ph.D.
  phone: 617-949-9089
  email: wbai@unc.edu
  last name: Arjun Putcha, B.S.
  phone: 704-954-4398
  email: arjun22@live.unc.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: No