<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/NCT03030924</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00016409</org_study_id>
    <secondary_id>5K12HL133115</secondary_id>
    <nct_id>NCT03030924</nct_id>
  </id_info>
  <brief_title>Wearable Suicidal Early Warning System for Adolescents</brief_title>
  <official_title>Physiologic Parameters for Monitoring Adolescent Suicidality</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study is prospectively enrolling a cohort of adolescent patients who present to the&#xD;
      Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is prospectively enrolling a cohort of adolescent patients who present to the&#xD;
      Emergency Department with acute suicidality or are admitted to an inpatient psychiatric&#xD;
      adolescent unit. The plan is to monitor basic physiologic parameters to assess for trends&#xD;
      associated with suicidality noninvasively in an objective manner beyond subjective&#xD;
      questionnaires currently available. Upon discharge they will be sent home with a noninvasive&#xD;
      monitor to track physiologic parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 18, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">July 1, 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>Heart Rate Variability</measure>
    <time_frame>1 week</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gender</measure>
    <time_frame>At enrollment</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age</measure>
    <time_frame>at enrollment</time_frame>
    <description>in Years</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Columbia Suicide Severity Score</measure>
    <time_frame>1 week</time_frame>
    <description>Numerical based on severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PHQ-9 Depression Scale</measure>
    <time_frame>1 week</time_frame>
    <description>Numerical based on severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motion</measure>
    <time_frame>1 week</time_frame>
    <description>As detected by an accelerometer in Hz</description>
  </secondary_outcome>
  <other_outcome>
    <measure>past Medical History</measure>
    <time_frame>At enrollment</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Medications</measure>
    <time_frame>At enrollment and daily for one week after discharge</time_frame>
    <description>Daily medications</description>
  </other_outcome>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Suicide</condition>
  <condition>Adolescent Behavior</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Solace</intervention_name>
    <description>Noninvasive physiologic monitor</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adolescents presenting with acute suicidal thoughts or attempts in the pediatric emergency&#xD;
        department (13-19 years of age).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  acute suicidality&#xD;
&#xD;
          -  consenting individual present in the emergency department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  medical admission for an ingestion or other reason&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>19 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>David Sheridan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Sheridan, MD</last_name>
    <phone>5034941691</phone>
    <email>sheridda@ohsu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>David C Sheridan, MD</last_name>
    <phone>5034941691</phone>
    <email>sheridda@ohsu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>OHSU</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>David Sheridan, MD</last_name>
      <phone>503-494-1691</phone>
      <email>sheridda@Ohsu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>September 20, 2022</last_update_submitted>
  <last_update_submitted_qc>September 20, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Dr. David Sheridan</investigator_full_name>
    <investigator_title>Assistant Professor of Emergency Medicine/Pediatrics</investigator_title>
  </responsible_party>
  <keyword>suicide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03030924
org study id: STUDY00016409
secondary id: 5K12HL133115
nct id: NCT03030924
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is prospectively enrolling a cohort of adolescent patients who present to the
      Emergency Department and an inpatient psychiatric adolescent unit with acute suicidality.
This study is prospectively enrolling a cohort of adolescent patients who present to the
      Emergency Department with acute suicidality or are admitted to an inpatient psychiatric
      adolescent unit. The plan is to monitor basic physiologic parameters to assess for trends
      associated with suicidality noninvasively in an objective manner beyond subjective
      questionnaires currently available. Upon discharge they will be sent home with a noninvasive
      monitor to track physiologic parameters.
observational model: Cohort
time perspective: Prospective
measure: Heart Rate Variability
time frame: 1 week
measure: Gender
time frame: At enrollment
measure: Age
time frame: at enrollment
description: in Years
measure: Columbia Suicide Severity Score
time frame: 1 week
description: Numerical based on severity
measure: PHQ-9 Depression Scale
time frame: 1 week
description: Numerical based on severity
measure: Motion
time frame: 1 week
description: As detected by an accelerometer in Hz
measure: past Medical History
time frame: At enrollment
measure: Medications
time frame: At enrollment and daily for one week after discharge
description: Daily medications
intervention type: Device
intervention name: Solace
description: Noninvasive physiologic monitor
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 19 Years
last name: David Sheridan, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
last name: David Sheridan, MD
phone: 5034941691
email: sheridda@ohsu.edu
last name: David C Sheridan, MD
phone: 5034941691
email: sheridda@ohsu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Dr. David Sheridan
investigator title: Assistant Professor of Emergency Medicine/Pediatrics
mesh term: Suicide
sharing ipd: No