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High School Start Time and Teen Migraine Frequency

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ClinicalTrials.gov Identifier: NCT03766412
Recruitment Status : Completed
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Amy Gelfand, University of California, San Francisco

Brief Summary:

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.


Condition or disease Intervention/treatment
Migraine Other: High School start time

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 256 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: High School Start Time and Adolescent Migraine Frequency
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : October 15, 2018
Actual Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Group/Cohort Intervention/treatment
School start time 8:30 AM or later
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).
Other: High School start time
The time that the school starts

School start time earlier than 8:30
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).
Other: High School start time
The time that the school starts




Primary Outcome Measures :
  1. Headache days per month [ Time Frame: Last 30 days ]
    How many headache days experienced in the last month


Secondary Outcome Measures :
  1. Hours of sleep on typical school night [ Time Frame: Last 30 days ]
    Respondent's estimate of hours of sleep on a typical school night

  2. Typical bedtime on school night [ Time Frame: Last 30 days ]
    Respondent's estimate of typical bedtime on school night

  3. Typical wake up time on a school day [ Time Frame: Last 30 days ]
    Respondent's estimate of typical wakeup time on a school day

  4. Number of missed breakfasts in a typical school week [ Time Frame: Last 30 days ]
    Respondent's estimate of how many times they miss breakfast in a typical school week

  5. Acute headache medication days per month [ Time Frame: Last 30 days ]
    How many days per month respondent uses acute headache medication

  6. PedMIDAS (Pediatric Migraine Disability Assessment Scale) [ Time Frame: Last 90 days ]
    Headache related disability score--Total score ranges from 0-246



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
U.S. High school students with migraine
Criteria

Inclusion criteria:

  1. Live in the U.S.
  2. In 9th-12th grade
  3. Attends a high school that is outside of the home (i.e. not home-schooled or online schooled)
  4. High school has a consistent start time all 5 days of the week
  5. Has migraine by International Classification of Headache Disorders criteria
  6. Can read and write in English

Exclusion criteria: NA


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766412


Locations
United States, California
University of California, San Francisco, (UCSF)
San Francisco, California, United States, 94158
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Amy A Gelfand, MD University of California, San Francisco

Responsible Party: Amy Gelfand, Assistant Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03766412     History of Changes
Other Study ID Numbers: High School Start Time Study
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases