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/NCT06027047</url>
    </required_header>
    <id_info>
      <org_study_id>ROA101</org_study_id>
      <nct_id>NCT06027047</nct_id>
    </id_info>
    <brief_title>Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)</brief_title>
    <acronym>BASEL</acronym>
    <official_title>Breakthrough Anxiety and Sleep Evaluation Using Linked Devices and Smartphone Application Onar (BASEL)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Raivotech</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Raivotech</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>
        Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally&#xD;
        happening every night, and is absolutely vital. Good sleep is essential for our well-being.&#xD;
        Survival without food can be further than without sleep. Work time and commuting time seem to&#xD;
        affect total sleep time and night bedtime. Social and work obligation can, therefore,&#xD;
        suppress sleep time. Sleep deprived individuals may be facing anxiety and depression&#xD;
        symptoms.&#xD;
  &#xD;
        The aim of this study is to investigate the presence of anxiety and depression symptoms among&#xD;
        adults with the use of the smartphone application Onar. Onar app will be used to gather&#xD;
        information from wearable devices of the users including total sleep time, sleep efficiency,&#xD;
        wake after sleep onset time. An established questionnaire (Hospital Anxiety Depression Scale/&#xD;
        HADS) will be used to quantify and detect the presence of anxiety and depression in the study&#xD;
        population.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">January 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 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>To determine the existence of depression and anxiety symptoms in the study population.</measure>
      <time_frame>2 weeks</time_frame>
      <description>Comparison of HADS score with population standardized mean value.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation of depression and anxiety symptoms with Total sleep time (TST).</measure>
      <time_frame>2 weeks</time_frame>
      <description>Total sleep time (TST).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).</measure>
      <time_frame>2 weeks</time_frame>
      <description>Wake after sleep onset time (WASO).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).</measure>
      <time_frame>2 weeks</time_frame>
      <description>Sleep Onset Latency (SOL).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).</measure>
      <time_frame>2 weeks</time_frame>
      <description>Epworth Sleepiness Scale (ESS).</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Sleep Deprivation</condition>
    <condition>Sleep Hygiene</condition>
    <condition>Sleepiness</condition>
    <condition>Sleep Driving</condition>
    <condition>Depression, Anxiety</condition>
    <condition>Anxiety Disorders</condition>
    <condition>Depressive Symptoms</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Subjects using the application on a daily basis for at least 1 week prior to participation&#xD;
          will be eligible for participation. After the first full week of data will be over, the&#xD;
          application will show a message asking for participation in the study and acceptance of&#xD;
          terms.&#xD;
  &#xD;
          Participants will continue using their smartwatch as usual and data will be collected from&#xD;
          a period of 2 week for each subject. At the end of the 2-week period a new message will be&#xD;
          asking the participant to complete the Hospital Anxiety and Depression Questionnaire (HADS)&#xD;
          and the Epworth Sleepiness Scale (ESS) and the total score will be stored.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Acceptance of terms of use of the application must be done prior to participation in&#xD;
               the study.&#xD;
  &#xD;
            -  Male and female adults aged ≥18 years old and ≤60 years old.&#xD;
  &#xD;
            -  Subjects using the application on a daily basis for at least 1 week prior to&#xD;
               participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of alcohol or other substance abuse.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Kyriakos Karkoulias, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospital of Patras, Greece</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Emmanouil Bakopoulos, MSc</last_name>
      <phone>+306945108313</phone>
      <email>info@raivotech.com</email>
    </overall_contact>
    <reference>
      <citation>Sforza E, de Saint Hilaire Z, Pelissolo A, Rochat T, Ibanez V. Personality, anxiety and mood traits in patients with sleep-related breathing disorders: effect of reduced daytime alertness. Sleep Med. 2002 Mar;3(2):139-45. doi: 10.1016/s1389-9457(01)00128-9.</citation>
      <PMID>14592233</PMID>
    </reference>
    <reference>
      <citation>Bixler EO, Vgontzas AN, Lin HM, Calhoun SL, Vela-Bueno A, Kales A. Excessive daytime sleepiness in a general population sample: the role of sleep apnea, age, obesity, diabetes, and depression. J Clin Endocrinol Metab. 2005 Aug;90(8):4510-5. doi: 10.1210/jc.2005-0035. Epub 2005 Jun 7.</citation>
      <PMID>15941867</PMID>
    </reference>
    <reference>
      <citation>Horenstein A, Morrison AS, Goldin P, Ten Brink M, Gross JJ, Heimberg RG. Sleep quality and treatment of social anxiety disorder. Anxiety Stress Coping. 2019 Jul;32(4):387-398. doi: 10.1080/10615806.2019.1617854. Epub 2019 May 13.</citation>
      <PMID>31082285</PMID>
    </reference>
    <reference>
      <citation>Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.</citation>
      <PMID>12914662</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 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>
    <keyword>smartphone</keyword>
    <keyword>wearables</keyword>
    <keyword>app</keyword>
    <keyword>sleep</keyword>
    <keyword>anxiety</keyword>
    <keyword>depression</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Deprivation</mesh_term>
      <mesh_term>Sleepiness</mesh_term>
      <mesh_term>Depression</mesh_term>
      <mesh_term>Anxiety Disorders</mesh_term>
    </condition_browse>
    <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/NCT06027047
  org study id: ROA101
  nct id: NCT06027047
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Sleep is not simply the absence of wakefulness. Sleep is an active procedure, normally
        happening every night, and is absolutely vital. Good sleep is essential for our well-being.
        Survival without food can be further than without sleep. Work time and commuting time seem to
        affect total sleep time and night bedtime. Social and work obligation can, therefore,
        suppress sleep time. Sleep deprived individuals may be facing anxiety and depression
        symptoms.
  
        The aim of this study is to investigate the presence of anxiety and depression symptoms among
        adults with the use of the smartphone application Onar. Onar app will be used to gather
        information from wearable devices of the users including total sleep time, sleep efficiency,
        wake after sleep onset time. An established questionnaire (Hospital Anxiety Depression Scale/
        HADS) will be used to quantify and detect the presence of anxiety and depression in the study
        population.
  observational model: Cohort
  time perspective: Prospective
  measure: To determine the existence of depression and anxiety symptoms in the study population.
  time frame: 2 weeks
  description: Comparison of HADS score with population standardized mean value.
  measure: Correlation of depression and anxiety symptoms with Total sleep time (TST).
  time frame: 2 weeks
  description: Total sleep time (TST).
  measure: Correlation of depression and anxiety symptoms with Wake after sleep onset time (WASO).
  time frame: 2 weeks
  description: Wake after sleep onset time (WASO).
  measure: Correlation of depression and anxiety symptoms with Sleep Onset Latency (SOL).
  time frame: 2 weeks
  description: Sleep Onset Latency (SOL).
  measure: Correlation of depression and anxiety symptoms with Epworth Sleepiness Scale (ESS).
  time frame: 2 weeks
  description: Epworth Sleepiness Scale (ESS).
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Kyriakos Karkoulias, Prof.
  role: Principal Investigator
  affiliation: University Hospital of Patras, Greece
  last name: Emmanouil Bakopoulos, MSc
  phone: +306945108313
  email: info@raivotech.com
  citation: Sforza E, de Saint Hilaire Z, Pelissolo A, Rochat T, Ibanez V. Personality, anxiety and mood traits in patients with sleep-related breathing disorders: effect of reduced daytime alertness. Sleep Med. 2002 Mar;3(2):139-45. doi: 10.1016/s1389-9457(01)00128-9.
  PMID: 14592233
  citation: Bixler EO, Vgontzas AN, Lin HM, Calhoun SL, Vela-Bueno A, Kales A. Excessive daytime sleepiness in a general population sample: the role of sleep apnea, age, obesity, diabetes, and depression. J Clin Endocrinol Metab. 2005 Aug;90(8):4510-5. doi: 10.1210/jc.2005-0035. Epub 2005 Jun 7.
  PMID: 15941867
  citation: Horenstein A, Morrison AS, Goldin P, Ten Brink M, Gross JJ, Heimberg RG. Sleep quality and treatment of social anxiety disorder. Anxiety Stress Coping. 2019 Jul;32(4):387-398. doi: 10.1080/10615806.2019.1617854. Epub 2019 May 13.
  PMID: 31082285
  citation: Snaith RP. The Hospital Anxiety And Depression Scale. Health Qual Life Outcomes. 2003 Aug 1;1:29. doi: 10.1186/1477-7525-1-29.
  PMID: 12914662
  responsible party type: Sponsor
  mesh term: Sleep Deprivation
  mesh term: Sleepiness
  mesh term: Depression
  mesh term: Anxiety Disorders
  sharing ipd: No