<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/NCT03788278</url>
  </required_header>
  <id_info>
    <org_study_id>SHEBA-5184-18-SMC</org_study_id>
    <nct_id>NCT03788278</nct_id>
  </id_info>
  <brief_title>An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder</brief_title>
  <official_title>An Advanced Digital Phenotype System Among People Suffering From Post-traumatic Stress Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nadav Goldental</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Chaim Sheba Medical Center</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>
      Psychiatric diagnosis is based mainly on questioning the patient and subjective impression&#xD;
      rather than a quantitative assessment. The assessment is usually done with long time&#xD;
      intervals between assessments and arbitrary in relation to the clinical course of the&#xD;
      disorder. Post-traumatic stress disorder has physiological, physical, and behavioral&#xD;
      manifestations. These changes appear as a response to different situations during the day and&#xD;
      can be measured directly and indirectly in order to obtain an objective, quantitative and&#xD;
      fuller picture of the severity and changes in the disorder. This is a non-interventional&#xD;
      pilot study, using a system that collects data through wearable sensors and smartphone over a&#xD;
      long period of time for patients suffering from PTSD and enables data analysis and&#xD;
      characterization of a personal digital phenotype using a dedicated algorithm. Based on this&#xD;
      pattern, the investigators will attempt to support the establishment of the PTSD diagnosis.&#xD;
      During the course of the study, the therapeutic procedure will not be affected by the study&#xD;
      and will be independent of the research.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 20, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 20, 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Correlations between data changes and PTSD clinical symptoms</measure>
    <time_frame>Three months</time_frame>
    <description>Investigators will use a wearable smart watch to collect physiological data (Heart Rate, Cardiac Output, Blood Pressure, Respiratory Rate, Steps Counter, Electro-Dermal Activity) and will use psychiatric rating score (CAPS 5, CGI, PHQ-SADS) to determine changes in clinical symptoms. The investigators will look for correlations between the collected physiological data and the clinical symptoms according to the psychiatric rating scales</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Post-traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>PTSD patients</arm_group_label>
    <description>Participants will attend clinical surveillance once every week or two. During the follow-up period, the participant will be checked as usual and will have to fill in questionnaires.&#xD;
Participants will be required to wear the smart watch at all times and will need to recharge it at least once every three days.&#xD;
Participants will be required to answer digital questionnaires twice a day via smartphone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non PTSD participants</arm_group_label>
    <description>Participants will attend clinical surveillance once every week or two. During the follow-up period, the participant will be checked as usual and will have to fill in questionnaires.&#xD;
Participants will be required to wear the smart watch at all times and will need to recharge it at least once every three days.&#xD;
Participants will be required to answer digital questionnaires twice a day via smartphone.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioBeat</intervention_name>
    <description>The watch incorporates sensors, a battery, a software system, memory components, and a communications component. the watch will be worn 24 hours a day, 7 days a week.</description>
    <arm_group_label>Non PTSD participants</arm_group_label>
    <arm_group_label>PTSD patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults aged 18 years and older from both sexes. The study group will include 25&#xD;
        participants with a diagnosis of PTSD. The participants will be recruited from among the&#xD;
        patients at the Ministry of Defense clinic at the Sheba Medical Center. The control group&#xD;
        will consist of 25 participants recruited from medical staff and students from the Sheba&#xD;
        Medical Center and Tel-Aviv University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for study group:&#xD;
&#xD;
          -  Current PTSD diagnosis based on DSM-5. We will aim to recruit patients with Clinically&#xD;
             Administered PTSD Scale (CAPS)- 5, medium severity and up.&#xD;
&#xD;
          -  A person who is being monitored by the Ministry of Defense PTSD clinic at the Sheba&#xD;
             Medical Center.&#xD;
&#xD;
          -  Proper ability to give informed consent.&#xD;
&#xD;
          -  A person with a smartphone that is not hacked with an Android version 2.3 or higher&#xD;
             (relevant to smartphones manufactured since 2011).&#xD;
&#xD;
        Inclusion Criteria for control group:&#xD;
&#xD;
          -  Proper ability to give informed consent.&#xD;
&#xD;
          -  A person with a smartphone that is not hacked with an Android version 2.3 or higher&#xD;
             (relevant to smartphones manufactured since 2011).&#xD;
&#xD;
        Exclusion Criteria for study group:&#xD;
&#xD;
          -  A person defined as a violent or suicidal person (significant events of physical&#xD;
             violence or suicidal behavior in the past year, according to the treating psychiatrist&#xD;
             professional opinion).&#xD;
&#xD;
          -  An active or terminal oncology disease or a dialysis patient.&#xD;
&#xD;
          -  A person who is not independent or reports that he/she will not meet the requirement&#xD;
             to wear the watch, recharge it or any other requirement arising from the use of the&#xD;
             watch.&#xD;
&#xD;
          -  A person without a smartphone that is not hacked or without Android version 2.3 or&#xD;
             higher (relevant to smartphones manufactured since 2011).&#xD;
&#xD;
        Exclusion Criteria for control group:&#xD;
&#xD;
          -  Current mental health diagnosis.&#xD;
&#xD;
          -  A person defined as a violent or suicidal person (significant events of physical&#xD;
             violence or suicidal behavior in the past year, according to the treating psychiatrist&#xD;
             professional opinion).&#xD;
&#xD;
          -  An active or terminal oncology disease or a dialysis patient.&#xD;
&#xD;
          -  A person who is not independent or reports that he/she will not meet the requirement&#xD;
             to wear the watch, recharge it or any other requirement arising from the use of the&#xD;
             watch.&#xD;
&#xD;
          -  A person without a smartphone that is not hacked or without Android version 2.3 or&#xD;
             higher (relevant to smartphones manufactured since 2011).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 26, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 27, 2018</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>The Chaim Sheba Medical Center</investigator_affiliation>
    <investigator_full_name>Nadav Goldental</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Digital psychiatry</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</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/NCT03788278
org study id: SHEBA-5184-18-SMC
nct id: NCT03788278
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Psychiatric diagnosis is based mainly on questioning the patient and subjective impression
      rather than a quantitative assessment. The assessment is usually done with long time
      intervals between assessments and arbitrary in relation to the clinical course of the
      disorder. Post-traumatic stress disorder has physiological, physical, and behavioral
      manifestations. These changes appear as a response to different situations during the day and
      can be measured directly and indirectly in order to obtain an objective, quantitative and
      fuller picture of the severity and changes in the disorder. This is a non-interventional
      pilot study, using a system that collects data through wearable sensors and smartphone over a
      long period of time for patients suffering from PTSD and enables data analysis and
      characterization of a personal digital phenotype using a dedicated algorithm. Based on this
      pattern, the investigators will attempt to support the establishment of the PTSD diagnosis.
      During the course of the study, the therapeutic procedure will not be affected by the study
      and will be independent of the research.
observational model: Cohort
time perspective: Prospective
measure: Correlations between data changes and PTSD clinical symptoms
time frame: Three months
description: Investigators will use a wearable smart watch to collect physiological data (Heart Rate, Cardiac Output, Blood Pressure, Respiratory Rate, Steps Counter, Electro-Dermal Activity) and will use psychiatric rating score (CAPS 5, CGI, PHQ-SADS) to determine changes in clinical symptoms. The investigators will look for correlations between the collected physiological data and the clinical symptoms according to the psychiatric rating scales
arm group label: PTSD patients
description: Participants will attend clinical surveillance once every week or two. During the follow-up period, the participant will be checked as usual and will have to fill in questionnaires.
Participants will be required to wear the smart watch at all times and will need to recharge it at least once every three days.
Participants will be required to answer digital questionnaires twice a day via smartphone.
arm group label: Non PTSD participants
description: Participants will attend clinical surveillance once every week or two. During the follow-up period, the participant will be checked as usual and will have to fill in questionnaires.
Participants will be required to wear the smart watch at all times and will need to recharge it at least once every three days.
Participants will be required to answer digital questionnaires twice a day via smartphone.
intervention type: Device
intervention name: BioBeat
description: The watch incorporates sensors, a battery, a software system, memory components, and a communications component. the watch will be worn 24 hours a day, 7 days a week.
arm group label: Non PTSD participants
arm group label: PTSD patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor-Investigator
investigator affiliation: The Chaim Sheba Medical Center
investigator full name: Nadav Goldental
investigator title: Principal investigator
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No