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/NCT05983731</url>
    </required_header>
    <id_info>
      <org_study_id>321547</org_study_id>
      <nct_id>NCT05983731</nct_id>
    </id_info>
    <brief_title>A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment</brief_title>
    <official_title>A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Surrey</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Guy's and St Thomas' NHS Foundation Trust</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>
        The goal of this pilot observational study is to assess the ability of continuous 'home' EEG&#xD;
        to accurately diagnose Narcolepsy in children and young people with hypersomnia. The main&#xD;
        question[s]it aims to answer are:&#xD;
  &#xD;
          -  can ambulatory home monitoring using a Dreem headband with a 'life as usual'&#xD;
             unrestricted protocol allow accurate diagnosis of Narcolepsy, compared to gold standard&#xD;
             in-patient PSG and MSLT&#xD;
  &#xD;
          -  which EEG derived sleep parameters and study duration yield most diagnostic accuracy&#xD;
  &#xD;
        Participants undergoing investigation for hypersomnia will additionally be asked to wear a&#xD;
        Dream Headband at night for weeknights, then continuously for 48 hours over the weekend. The&#xD;
        data from the headband will then be analysed to see if it can predict the results of the&#xD;
        polysomnography and MSLT that form routine clinical care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">August 2025</completion_date>
    <primary_completion_date type="Anticipated">April 2025</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>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Sensitivity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol</measure>
      <time_frame>2 years</time_frame>
      <description>Sensitivity (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Specificity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol</measure>
      <time_frame>2 years</time_frame>
      <description>Specificity (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Positive predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol</measure>
      <time_frame>2 years</time_frame>
      <description>Positive predictive value (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Negative predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol</measure>
      <time_frame>2 years</time_frame>
      <description>Negative predictive value (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.</description>
    </primary_outcome>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Narcolepsy Type 1</condition>
    <condition>Hypersomnia</condition>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will comprise children and young adults seen in the hypersomnia&#xD;
          clinics of the LifeSpan sleep service at Guys and St Thomas' Hospital and The Evelina&#xD;
          London Children's Hospital.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Participants already under investigation within GSTT children and adult sleep service&#xD;
               for hypersomnolence&#xD;
  &#xD;
            -  Age 12 to 25 years of age at recruitment&#xD;
  &#xD;
            -  Participants able to understand patient information (information including DH&#xD;
               instructions written only in English for this initial observational study) and who can&#xD;
               provide written informed consent or assent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Any physician diagnosed sleep disorder (e.g. sleep apnea)&#xD;
  &#xD;
            -  Any physician diagnosed medical or psychiatric disorder that could explain their&#xD;
               excessive daytime sleepiness&#xD;
  &#xD;
            -  Regular use of either prescribed or recreational medication that affects sleep&#xD;
  &#xD;
            -  Participation in another concurrent research study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Thomas Rossor, PhD</last_name>
      <phone>+442071887188</phone>
      <email>thomas.rossor@gstt.nhs.uk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Paul Gringras</last_name>
      <email>paul.gringras@gstt.nhs.uk</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Narcolepsy</mesh_term>
      <mesh_term>Disorders of Excessive Somnolence</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/NCT05983731
  org study id: 321547
  nct id: NCT05983731
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this pilot observational study is to assess the ability of continuous 'home' EEG
        to accurately diagnose Narcolepsy in children and young people with hypersomnia. The main
        question[s]it aims to answer are:
  
          -  can ambulatory home monitoring using a Dreem headband with a 'life as usual'
             unrestricted protocol allow accurate diagnosis of Narcolepsy, compared to gold standard
             in-patient PSG and MSLT
  
          -  which EEG derived sleep parameters and study duration yield most diagnostic accuracy
  
        Participants undergoing investigation for hypersomnia will additionally be asked to wear a
        Dream Headband at night for weeknights, then continuously for 48 hours over the weekend. The
        data from the headband will then be analysed to see if it can predict the results of the
        polysomnography and MSLT that form routine clinical care.
  observational model: Other
  time perspective: Prospective
  measure: Sensitivity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol
  time frame: 2 years
  description: Sensitivity (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.
  measure: Specificity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol
  time frame: 2 years
  description: Specificity (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.
  measure: Positive predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol
  time frame: 2 years
  description: Positive predictive value (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.
  measure: Negative predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol
  time frame: 2 years
  description: Negative predictive value (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Thomas Rossor, PhD
  phone: +442071887188
  email: thomas.rossor@gstt.nhs.uk
  last name: Paul Gringras
  email: paul.gringras@gstt.nhs.uk
  responsible party type: Sponsor
  mesh term: Narcolepsy
  mesh term: Disorders of Excessive Somnolence
  sharing ipd: No