<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/NCT02222103</url>
  </required_header>
  <id_info>
    <org_study_id>RDS-Sleep Apnea</org_study_id>
    <nct_id>NCT02222103</nct_id>
  </id_info>
  <brief_title>Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles</brief_title>
  <official_title>Pilot Study of the MultiSense Patch to Record Cardiopulmonary Data During Sleep and Wake Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Scripps Translational Science Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Scripps Clinic</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Scripps Translational Science Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm&#xD;
      Diagnostic Systems, Inc. which has many sensors inside in a &quot;Band-Aid&quot; like strip in order to&#xD;
      see if it can help diagnose capabilities in individuals suspected of having obstructive sleep&#xD;
      apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered,&#xD;
      flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of&#xD;
      physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen&#xD;
      saturation, temperature, respiratory rate, depth of respiration and motion/position. One&#xD;
      advantage of this device over current home diagnostic systems is the capability for recording&#xD;
      over several nights.&#xD;
&#xD;
      The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold&#xD;
      standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will&#xD;
      explore potential findings supportive of sleep apnea while monitoring at home during routine&#xD;
      sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated&#xD;
      sleep study will help us to make these determinations. Subjects will wear the device, which&#xD;
      is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects&#xD;
      will go about their normal daily activities and return the device via mail once completed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea</measure>
    <time_frame>10 days</time_frame>
    <description>To compare multiple biometric parameters tracked by the MultiSenseTM to gold-standard monitoring in an accredited sleep lab using polysomnography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Home monitoring</measure>
    <time_frame>10 days</time_frame>
    <description>Explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">10</enrollment>
  <condition>Obstructive Sleep Apnea of Adult</condition>
  <arm_group>
    <arm_group_label>Suspected obstructive sleep apnea in adults</arm_group_label>
    <description>Already scheduled in-lab sleep study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be adults men and women suspected of having obstructive sleep apnea and&#xD;
        already scheduled for an in-lab sleep study at the Scripps Clinic Viterbi Family Sleep&#xD;
        Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults over age 18&#xD;
&#xD;
          -  Considered to be at high likelihood for sleep apnea and already scheduled for a formal&#xD;
             sleep study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congestive heart failure or other major medical illness that would complicate the&#xD;
             diagnosis of OSA.&#xD;
&#xD;
          -  Psychological or social situation that would make the study difficult for the patient.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steven Steinhubl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>STSI</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Scripps Translational Science Institute</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Scripps Translational Science Institute</investigator_affiliation>
    <investigator_full_name>Steven Steinhubl</investigator_full_name>
    <investigator_title>Director, Digital Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sleep Apnea, Obstructive</mesh_term>
  </condition_browse>
  <!-- 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/NCT02222103
org study id: RDS-Sleep Apnea
nct id: NCT02222103
lead sponsor: 
collaborator: 
has dmc: No
The investigators are proposing to use a wearable device, MultiSenseTM, developed by Rhythm
      Diagnostic Systems, Inc. which has many sensors inside in a "Band-Aid" like strip in order to
      see if it can help diagnose capabilities in individuals suspected of having obstructive sleep
      apnea. The MultiSenseTM sensor is a self-contained, reusable, rechargeable, battery-powered,
      flexible strip, measuring 4 X 1.2 inches that simultaneously tracks and records a number of
      physiological health related parameters such as ECG, heart rate, pulse synchronized oxygen
      saturation, temperature, respiratory rate, depth of respiration and motion/position. One
      advantage of this device over current home diagnostic systems is the capability for recording
      over several nights.

      The objective is to compare multiple biometric parameters tracked by the MultiSenseTM to gold
      standard monitoring in an accredited sleep lab using polysomnography. Home monitoring will
      explore potential findings supportive of sleep apnea while monitoring at home during routine
      sleep over 5 to 7 nights. Enrolling 10 adults already scheduled for a medically indicated
      sleep study will help us to make these determinations. Subjects will wear the device, which
      is the size of a Band-Aid, via adhesive to their chest over a period of 10 days. Subjects
      will go about their normal daily activities and return the device via mail once completed.
observational model: Other
time perspective: Other
measure: Direct Comparison of MultiSenseTM to Polysomnography for detection of sleep apnea
time frame: 10 days
description: To compare multiple biometric parameters tracked by the MultiSenseTM to gold-standard monitoring in an accredited sleep lab using polysomnography.
measure: Home monitoring
time frame: 10 days
description: Explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights.
arm group label: Suspected obstructive sleep apnea in adults
description: Already scheduled in-lab sleep study
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Steven Steinhubl, MD
role: Principal Investigator
affiliation: STSI
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Scripps Translational Science Institute
investigator full name: Steven Steinhubl
investigator title: Director, Digital Medicine
mesh term: Sleep Apnea, Obstructive