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/NCT06006442</url>
    </required_header>
    <id_info>
      <org_study_id>TatumVRS</org_study_id>
      <nct_id>NCT06006442</nct_id>
    </id_info>
    <brief_title>Vaping-Related Seizures - A Prospective Study</brief_title>
    <official_title>Vaping-Related Seizures - A Prospective Case-Crossover Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dartmouth-Hitchcock Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dartmouth-Hitchcock Medical Center</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>
        This case-crossover study evaluates the association between vaping and seizures in patients&#xD;
        of a large academic medical center who admits to vaping and hav a planned ambulatory EEG&#xD;
        ordered.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This case-crossover study will evaluate the short-term effects (seizures) of intermittent&#xD;
        exposure to vaping nicotine and/or marijuana products among Dartmouth Hitchcock Medical&#xD;
        Center (DHMC) patients aged 21 years or older who already have planned ambulatory EEG study&#xD;
        ordered and admit to vaping. The duration of data collection will vary (24-72 hours)&#xD;
        depending on ambulatory EEG length was ordered.&#xD;
  &#xD;
        Inclusion criteria includes any DHMC patient who admits to vaping and has a planned&#xD;
        ambulatory EEG of any duration, regardless of diagnosis or reason for study. Exclusion&#xD;
        criteria will include subjectively admitting to using any illicit drugs other than&#xD;
        cannabinoids since within 7 days of the study and/or anyone who denies smoking since it would&#xD;
        be an ethical issue having someone smoke for the first time during a research study.&#xD;
  &#xD;
        All subjects will sign a DHMC and IRB approved consent form to participate in the study&#xD;
        before it starts. They will receive one copy and another copy will be kept by DHMC in the&#xD;
        patient chart. An optional survey/questionnaire will be obtained before the study to confirm&#xD;
        if the patient vapes, what products and doses they use, and what other medications or drugs&#xD;
        they use. Personal information will also be obtained for later stratification, including age,&#xD;
        sex, sexuality, household income, race, ethnicity, heritage, culture, education level,&#xD;
        medical history, psychiatric history.&#xD;
  &#xD;
        During the study, subjects will keep a vaping diary for 24 to 72 hours depending on how long&#xD;
        their study was ordered for. All patients will document the dates, times, contents, brands,&#xD;
        sources, doses, and durations of use in their vaping diary which will be handed to the&#xD;
        research team at the end of the study.&#xD;
  &#xD;
        Each patient will serve as their own control by assessing EEG for seizures and interictal&#xD;
        discharges at different times as follows:&#xD;
  &#xD;
          -  A 60-minute period starting 60 minutes prior to the start of a vaping event which was&#xD;
             associated with a seizure.&#xD;
  &#xD;
          -  A 30-minute period starting 8 hours prior to the start of a vaping event which was&#xD;
             associated with a seizure.&#xD;
  &#xD;
          -  A 30-minute period starting 24 hours prior to the start of a vaping event which was&#xD;
             associated with a seizure.&#xD;
  &#xD;
          -  A 30-minute period randomly selected during a time that no seizures objectively occurred&#xD;
             on EEG&#xD;
  &#xD;
        During the analysis phase of the study, data will be stratified for age, sex, race,&#xD;
        ethnicity, current socio-economic status, prescription medications with known epileptogenic&#xD;
        side effects, prior diagnosis of psychogenic non-epileptic seizures, prior psychiatric&#xD;
        diagnoses, and prior poly-substance with a negative drug test at time of study.&#xD;
  &#xD;
        Outcome measures will include the odds of having seizures or interictal discharges during the&#xD;
        4 control times will be calculated and compared to the odds of experiencing a seizure or&#xD;
        interictal discharge within the hypothesized one hour after completing vaping. The&#xD;
        quantitative outcome will be odds ratios.&#xD;
  &#xD;
        There is no risk put placed on patients in this study since they are using vaping products&#xD;
        without alteration from their daily life.&#xD;
  &#xD;
        EEG data will be obtained from DHMC epilepsy patients through the NATUS system. Data will be&#xD;
        stored in the patient's electronic medical record system at DHMC. Only members of the&#xD;
        epilepsy team at DHMC will have access to this password protected research data which will&#xD;
        include: EEG recordings, patient and staff member journal entry, pre-study survey, EDH note,&#xD;
        Signed consent&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">May 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Odds of Vaping Related Seizure</measure>
      <time_frame>The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping</time_frame>
      <description>Odds ratio of vaping during periods of seizures versus periods of seizure freedom.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Odds of Increased Interictal Discharges After Vaping</measure>
      <time_frame>The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping</time_frame>
      <description>Odds ratio of vaping during periods of increased epileptiform discharges compared to normal baseline EEG background.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Evaluate the Association of Vaping With Seizures</condition>
    <arm_group>
      <arm_group_label>DHMC Ambulatory EEG Patients</arm_group_label>
      <description>Dartmouth Hitchcock Medical Center (DHMC) patients aged 21 years or older who already have planned ambulatory EEG study ordered and admit to vaping.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Vaping</intervention_name>
      <description>Subjects will be smoking the vapnig products that they admitted to using at baseline in the personal life prior to this study</description>
      <arm_group_label>DHMC Ambulatory EEG Patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Any DHMC patient aged 21 years or above with a planned ambulatory electroencephalogram&#xD;
          (EEG) of any duration, regardless of diagnosis or reason for study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Inclusion criteria includes any DHMC patient who admits to vaping and has a planned&#xD;
               ambulatory EEG of any duration, regardless of diagnosis or reason for study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Exclusion criteria will include subjectively admitting to using any illicit drugs&#xD;
               other than cannabinoids since within 7 days of the study and/or anyone who denies&#xD;
               smoking since it would be an ethical issue having someone smoke for the first time&#xD;
               during a research study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Peter S Tatum, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dartmouth-Hitchcock Medical Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Peter S Tatum, DO</last_name>
      <phone>(603) 650-5104</phone>
      <email>peter.s.tatum@hitchcock.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dartmouth-Hitchcock Medical Center</name>
        <address>
          <city>Lebanon</city>
          <state>New Hampshire</state>
          <zip>03756</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Peter S Tatum, DO</last_name>
        <phone>603-650-5104</phone>
        <email>peters.s.tatum@hitchcock.org</email>
      </contact>
      <contact_backup>
        <phone_ext>Tatum</phone_ext>
        <email>petertatum1@gmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Peter S Tatum, DO</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dartmouth-Hitchcock Medical Center</investigator_affiliation>
      <investigator_full_name>Peter.S.Tatum</investigator_full_name>
      <investigator_title>Epilepsy Fellow</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Seizures</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT06006442
  org study id: TatumVRS
  nct id: NCT06006442
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This case-crossover study evaluates the association between vaping and seizures in patients
        of a large academic medical center who admits to vaping and hav a planned ambulatory EEG
        ordered.
  This case-crossover study will evaluate the short-term effects (seizures) of intermittent
        exposure to vaping nicotine and/or marijuana products among Dartmouth Hitchcock Medical
        Center (DHMC) patients aged 21 years or older who already have planned ambulatory EEG study
        ordered and admit to vaping. The duration of data collection will vary (24-72 hours)
        depending on ambulatory EEG length was ordered.
  
        Inclusion criteria includes any DHMC patient who admits to vaping and has a planned
        ambulatory EEG of any duration, regardless of diagnosis or reason for study. Exclusion
        criteria will include subjectively admitting to using any illicit drugs other than
        cannabinoids since within 7 days of the study and/or anyone who denies smoking since it would
        be an ethical issue having someone smoke for the first time during a research study.
  
        All subjects will sign a DHMC and IRB approved consent form to participate in the study
        before it starts. They will receive one copy and another copy will be kept by DHMC in the
        patient chart. An optional survey/questionnaire will be obtained before the study to confirm
        if the patient vapes, what products and doses they use, and what other medications or drugs
        they use. Personal information will also be obtained for later stratification, including age,
        sex, sexuality, household income, race, ethnicity, heritage, culture, education level,
        medical history, psychiatric history.
  
        During the study, subjects will keep a vaping diary for 24 to 72 hours depending on how long
        their study was ordered for. All patients will document the dates, times, contents, brands,
        sources, doses, and durations of use in their vaping diary which will be handed to the
        research team at the end of the study.
  
        Each patient will serve as their own control by assessing EEG for seizures and interictal
        discharges at different times as follows:
  
          -  A 60-minute period starting 60 minutes prior to the start of a vaping event which was
             associated with a seizure.
  
          -  A 30-minute period starting 8 hours prior to the start of a vaping event which was
             associated with a seizure.
  
          -  A 30-minute period starting 24 hours prior to the start of a vaping event which was
             associated with a seizure.
  
          -  A 30-minute period randomly selected during a time that no seizures objectively occurred
             on EEG
  
        During the analysis phase of the study, data will be stratified for age, sex, race,
        ethnicity, current socio-economic status, prescription medications with known epileptogenic
        side effects, prior diagnosis of psychogenic non-epileptic seizures, prior psychiatric
        diagnoses, and prior poly-substance with a negative drug test at time of study.
  
        Outcome measures will include the odds of having seizures or interictal discharges during the
        4 control times will be calculated and compared to the odds of experiencing a seizure or
        interictal discharge within the hypothesized one hour after completing vaping. The
        quantitative outcome will be odds ratios.
  
        There is no risk put placed on patients in this study since they are using vaping products
        without alteration from their daily life.
  
        EEG data will be obtained from DHMC epilepsy patients through the NATUS system. Data will be
        stored in the patient's electronic medical record system at DHMC. Only members of the
        epilepsy team at DHMC will have access to this password protected research data which will
        include: EEG recordings, patient and staff member journal entry, pre-study survey, EDH note,
        Signed consent
  observational model: Case-Control
  time perspective: Prospective
  measure: Odds of Vaping Related Seizure
  time frame: The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping
  description: Odds ratio of vaping during periods of seizures versus periods of seizure freedom.
  measure: Odds of Increased Interictal Discharges After Vaping
  time frame: The hour before and after vaping, 8 hours prior to vaping, and 24 hours prior to vaping
  description: Odds ratio of vaping during periods of increased epileptiform discharges compared to normal baseline EEG background.
  arm group label: DHMC Ambulatory EEG Patients
  description: Dartmouth Hitchcock Medical Center (DHMC) patients aged 21 years or older who already have planned ambulatory EEG study ordered and admit to vaping.
  intervention type: Behavioral
  intervention name: Vaping
  description: Subjects will be smoking the vapnig products that they admitted to using at baseline in the personal life prior to this study
  arm group label: DHMC Ambulatory EEG Patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  last name: Peter S Tatum, DO
  role: Principal Investigator
  affiliation: Dartmouth-Hitchcock Medical Center
  last name: Peter S Tatum, DO
  phone: (603) 650-5104
  email: peter.s.tatum@hitchcock.org
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Dartmouth-Hitchcock Medical Center
  investigator full name: Peter.S.Tatum
  investigator title: Epilepsy Fellow
  mesh term: Seizures
  sharing ipd: Undecided