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/NCT05991492</url>
    </required_header>
    <id_info>
      <org_study_id>2023P001950</org_study_id>
      <nct_id>NCT05991492</nct_id>
    </id_info>
    <brief_title>Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application</brief_title>
    <acronym>STELLAR</acronym>
    <official_title>Improving Sleep With a Digital Cognitive Behavioral Therapy for Insomnia Application</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Brigham and Women's Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Brigham and Women's Hospital</source>
    <oversight_info>
      <has_dmc>No</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>
        Insomnia is an important public health problem and the most common sleep disorder in the&#xD;
        general population. Up to 20% of adults in the United States suffer from insomnia disorder,&#xD;
        and it has been associated with increased morbidity, mortality, and healthcare costs.&#xD;
        Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment&#xD;
        approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over&#xD;
        CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and&#xD;
        availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and&#xD;
        effective self-management tool for treatment of insomnia.&#xD;
  &#xD;
        This pilot study would test the efficacy of a new digital CBT-I application called Stellar&#xD;
        Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This&#xD;
        is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable&#xD;
        devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the&#xD;
        efficacy of this application will provide the preliminary data necessary for larger trials to&#xD;
        further validate the application and determine its role for future patients. Use of this&#xD;
        application can help bridge the gap in providing care to insomnia patients with&#xD;
        transportation and cost barriers and to accommodate the long wait times for traditional&#xD;
        in-person CBT-I. It will also be the first web-based CBT-I application that can directly&#xD;
        upload data from a wearable device.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Crossover Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Insomnia Severity Index (ISI)</measure>
      <time_frame>6-8 weeks</time_frame>
      <description>Mean change in Insomnia Severity Index (ISI) score from baseline to end of intervention. Score ranges from 0 to 28, with higher scores indicating a worse outcome.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Insomnia</condition>
    <arm_group>
      <arm_group_label>Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I) with general sleep education</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>General Sleep Education</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I</intervention_name>
      <description>Digital insomnia treatment</description>
      <arm_group_label>Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I) with general sleep education</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  Daily access to a computer or smartphone with reliable internet connection&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently pregnant or planning to become pregnant in the next year&#xD;
  &#xD;
            -  Visual impairment that prevents use of a computer&#xD;
  &#xD;
            -  Serious health conditions that will prevent taking part in the study over the next 3 -&#xD;
               6 months, such as severe medical or psychiatric disease, such as treatments for cancer&#xD;
               or congestive heart failure, OR a condition that may require hospitalization or&#xD;
               surgery&#xD;
  &#xD;
            -  Self-reported history of drowsy driving or fallen asleep while driving&#xD;
  &#xD;
            -  Night shift worker&#xD;
  &#xD;
            -  Prior exposure to Cognitive Behavioral Therapy for Insomnia (CBT-I) treatment&#xD;
  &#xD;
            -  Insomnia severity index score &lt; 14&#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_contact>
      <last_name>Michelle Reid</last_name>
      <phone>5164760541</phone>
      <email>mlreid@bwh.harvard.edu</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 6, 2023</study_first_submitted>
    <study_first_submitted_qc>August 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
      <investigator_full_name>Sogol Javaheri</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sleep Initiation and Maintenance 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/NCT05991492
  org study id: 2023P001950
  nct id: NCT05991492
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Insomnia is an important public health problem and the most common sleep disorder in the
        general population. Up to 20% of adults in the United States suffer from insomnia disorder,
        and it has been associated with increased morbidity, mortality, and healthcare costs.
        Cognitive behavioral therapy for insomnia (CBT-I) is the initial recommended treatment
        approach for insomnia. Combined therapy with CBT-I and medication has shown no advantage over
        CBT-I alone. CBT-I is not always accessible to patients, however, due to cost and
        availability of trained healthcare professionals. Web-based CBT-I is an inexpensive and
        effective self-management tool for treatment of insomnia.
  
        This pilot study would test the efficacy of a new digital CBT-I application called Stellar
        Sleep, a cost effective and user-friendly version of wCBT-I, in patients with insomnia. This
        is the first digital CBT-I app that allows automatic entry of sleep diary data from wearable
        devices that track sleep (such as the Mi Band 5 or a FitBit, for instance). Testing the
        efficacy of this application will provide the preliminary data necessary for larger trials to
        further validate the application and determine its role for future patients. Use of this
        application can help bridge the gap in providing care to insomnia patients with
        transportation and cost barriers and to accommodate the long wait times for traditional
        in-person CBT-I. It will also be the first web-based CBT-I application that can directly
        upload data from a wearable device.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Insomnia Severity Index (ISI)
  time frame: 6-8 weeks
  description: Mean change in Insomnia Severity Index (ISI) score from baseline to end of intervention. Score ranges from 0 to 28, with higher scores indicating a worse outcome.
  arm group label: Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I) with general sleep education
  arm group type: Active Comparator
  arm group label: General Sleep Education
  arm group type: No Intervention
  intervention type: Device
  intervention name: Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I
  description: Digital insomnia treatment
  arm group label: Web-based Cognitive Behavioral Therapy for Insomnia (wCBT-I) with general sleep education
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Michelle Reid
  phone: 5164760541
  email: mlreid@bwh.harvard.edu
  responsible party type: Principal Investigator
  investigator affiliation: Brigham and Women's Hospital
  investigator full name: Sogol Javaheri
  investigator title: Principal Investigator
  mesh term: Sleep Initiation and Maintenance Disorders
  sharing ipd: No