<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/NCT03268538</url>
  </required_header>
  <id_info>
    <org_study_id>2016.454</org_study_id>
    <nct_id>NCT03268538</nct_id>
  </id_info>
  <brief_title>Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation</brief_title>
  <official_title>Evaluation of Finger Wearable Device to Monitor Heart Rate Variability and Oxygen Saturation in Older People</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and&#xD;
      the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to&#xD;
      monitor oxygen saturation in older people with COPD. A finger wearable device has been&#xD;
      developed to measure oxygen saturation and heart rate variability. The investigators&#xD;
      therefore will perform a cross sectional study to evaluate the clinical application of this&#xD;
      finger wearable device in the detection and management of COPD in older people.&#xD;
&#xD;
      Subject and method: 100 COPD subjects and 200 community dwelling older people without&#xD;
      diagnosis of COPD will be recruited. Physical functioning and lung function test will be&#xD;
      performed. Subjects will wear a finger wearable device to monitor heart rate variability and&#xD;
      oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical&#xD;
      activity and sleep for 6 days at the same time.&#xD;
&#xD;
      Statistical analysis: Statistical analysis will be made to examine the potential association&#xD;
      between oxygen saturation and physical activity and sleep, and the association between heart&#xD;
      rate variability and physical activity and sleep.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">August 27, 2018</completion_date>
  <primary_completion_date type="Actual">August 27, 2018</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>COPD</measure>
    <time_frame>6 days</time_frame>
    <description>COPD as defined by lung function</description>
  </primary_outcome>
  <enrollment type="Actual">277</enrollment>
  <condition>COPD</condition>
  <eligibility>
    <study_pop>
      <textblock>
        100 COPD and 200 healthy older people&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 60 years old or more with or without COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medicine</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>May 2, 2019</last_update_submitted>
  <last_update_submitted_qc>May 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Timothy Kwok</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03268538
org study id: 2016.454
nct id: NCT03268538
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Introduction: Chronic obstructive airway disease (COPD) is common condition in old age and
      the perception of hypoxia is often impaired in some COPD patients. Therefor it is need to
      monitor oxygen saturation in older people with COPD. A finger wearable device has been
      developed to measure oxygen saturation and heart rate variability. The investigators
      therefore will perform a cross sectional study to evaluate the clinical application of this
      finger wearable device in the detection and management of COPD in older people.

      Subject and method: 100 COPD subjects and 200 community dwelling older people without
      diagnosis of COPD will be recruited. Physical functioning and lung function test will be
      performed. Subjects will wear a finger wearable device to monitor heart rate variability and
      oxygen saturation and wear another wrist wearable device (Actigraph) to monitor physical
      activity and sleep for 6 days at the same time.

      Statistical analysis: Statistical analysis will be made to examine the potential association
      between oxygen saturation and physical activity and sleep, and the association between heart
      rate variability and physical activity and sleep.
observational model: Cohort
time perspective: Prospective
measure: COPD
time frame: 6 days
description: COPD as defined by lung function
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Timothy Kwok
investigator title: Professor