<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/NCT03766412</url>
  </required_header>
  <id_info>
    <org_study_id>High School Start Time Study</org_study_id>
    <nct_id>NCT03766412</nct_id>
  </id_info>
  <brief_title>High School Start Time and Teen Migraine Frequency</brief_title>
  <official_title>High School Start Time and Adolescent Migraine Frequency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</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>
      Migraine is common in adolescents and can cause missed school and disability.&#xD;
&#xD;
      The American Academy of Pediatrics (AAP) recommends that high schools start no earlier than&#xD;
      8:30 AM in order to accommodate the physiologic needs of adolescents-whose brains naturally&#xD;
      want to fall asleep later and wake up later and who still need to get at least 8 hours of&#xD;
      sleep per night to function optimally-however, only about 18% of US high schools comply with&#xD;
      this AAP recommendation. There is a relationship between adequate sleep and migraine. The&#xD;
      investigators aim to determine whether high school students with migraine who attend high&#xD;
      schools that comply with this AAP recommendation have lower migraine frequency than those&#xD;
      that do not.&#xD;
&#xD;
      If so, it would argue for advocating for changes in high school policy to optimize health of&#xD;
      adolescents with migraine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design: This is an observational study of high-school students in the U.S. who have&#xD;
      migraine and who attend a standard high school (i.e. are not home schooled or online&#xD;
      schooled). They will complete a one-time online survey answering questions about their&#xD;
      headaches and their schedule--particularly schedule aspects related to school and sleep.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">October 15, 2018</completion_date>
  <primary_completion_date type="Actual">October 15, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Headache days per month</measure>
    <time_frame>Last 30 days</time_frame>
    <description>How many headache days experienced in the last month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hours of sleep on typical school night</measure>
    <time_frame>Last 30 days</time_frame>
    <description>Respondent's estimate of hours of sleep on a typical school night</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Typical bedtime on school night</measure>
    <time_frame>Last 30 days</time_frame>
    <description>Respondent's estimate of typical bedtime on school night</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Typical wake up time on a school day</measure>
    <time_frame>Last 30 days</time_frame>
    <description>Respondent's estimate of typical wakeup time on a school day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of missed breakfasts in a typical school week</measure>
    <time_frame>Last 30 days</time_frame>
    <description>Respondent's estimate of how many times they miss breakfast in a typical school week</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute headache medication days per month</measure>
    <time_frame>Last 30 days</time_frame>
    <description>How many days per month respondent uses acute headache medication</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PedMIDAS (Pediatric Migraine Disability Assessment Scale)</measure>
    <time_frame>Last 90 days</time_frame>
    <description>Headache related disability score--Total score ranges from 0-246</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">256</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>School start time 8:30 AM or later</arm_group_label>
    <description>These are high schoolers with migraine who attend a school that begins at 8:30 AM or later (i.e. follows AAP recommendation re: high school start time).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>School start time earlier than 8:30</arm_group_label>
    <description>These are high schoolers with migraine who attend a school that begins earlier than 8:30 AM (i.e. does not follow AAP recommendation re: high school start time).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High School start time</intervention_name>
    <description>The time that the school starts</description>
    <arm_group_label>School start time 8:30 AM or later</arm_group_label>
    <arm_group_label>School start time earlier than 8:30</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        U.S. High school students with migraine&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          1. Live in the U.S.&#xD;
&#xD;
          2. In 9th-12th grade&#xD;
&#xD;
          3. Attends a high school that is outside of the home (i.e. not home-schooled or online&#xD;
             schooled)&#xD;
&#xD;
          4. High school has a consistent start time all 5 days of the week&#xD;
&#xD;
          5. Has migraine by International Classification of Headache Disorders criteria&#xD;
&#xD;
          6. Can read and write in English&#xD;
&#xD;
        Exclusion criteria: NA&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amy A Gelfand, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco, (UCSF)</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Amy Gelfand</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine 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>


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/NCT03766412
org study id: High School Start Time Study
nct id: NCT03766412
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Migraine is common in adolescents and can cause missed school and disability.

      The American Academy of Pediatrics (AAP) recommends that high schools start no earlier than
      8:30 AM in order to accommodate the physiologic needs of adolescents-whose brains naturally
      want to fall asleep later and wake up later and who still need to get at least 8 hours of
      sleep per night to function optimally-however, only about 18% of US high schools comply with
      this AAP recommendation. There is a relationship between adequate sleep and migraine. The
      investigators aim to determine whether high school students with migraine who attend high
      schools that comply with this AAP recommendation have lower migraine frequency than those
      that do not.

      If so, it would argue for advocating for changes in high school policy to optimize health of
      adolescents with migraine.
Study design: This is an observational study of high-school students in the U.S. who have
      migraine and who attend a standard high school (i.e. are not home schooled or online
      schooled). They will complete a one-time online survey answering questions about their
      headaches and their schedule--particularly schedule aspects related to school and sleep.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Headache days per month
time frame: Last 30 days
description: How many headache days experienced in the last month
measure: Hours of sleep on typical school night
time frame: Last 30 days
description: Respondent's estimate of hours of sleep on a typical school night
measure: Typical bedtime on school night
time frame: Last 30 days
description: Respondent's estimate of typical bedtime on school night
measure: Typical wake up time on a school day
time frame: Last 30 days
description: Respondent's estimate of typical wakeup time on a school day
measure: Number of missed breakfasts in a typical school week
time frame: Last 30 days
description: Respondent's estimate of how many times they miss breakfast in a typical school week
measure: Acute headache medication days per month
time frame: Last 30 days
description: How many days per month respondent uses acute headache medication
measure: PedMIDAS (Pediatric Migraine Disability Assessment Scale)
time frame: Last 90 days
description: Headache related disability score--Total score ranges from 0-246
arm group label: School start time 8:30 AM or later
description: These are high schoolers with migraine who attend a school that begins at 8:30 AM or later (i.e. follows AAP recommendation re: high school start time).
arm group label: School start time earlier than 8:30
description: These are high schoolers with migraine who attend a school that begins earlier than 8:30 AM (i.e. does not follow AAP recommendation re: high school start time).
intervention type: Other
intervention name: High School start time
description: The time that the school starts
arm group label: School start time 8:30 AM or later
arm group label: School start time earlier than 8:30
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Amy A Gelfand, MD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Amy Gelfand
investigator title: Assistant Professor
mesh term: Migraine Disorders
sharing ipd: No