- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03766412
High School Start Time and Teen Migraine Frequency
High School Start Time and Adolescent Migraine Frequency
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 Overview
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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San Francisco, California, United States, 94158
- University of California, San Francisco, (UCSF)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion criteria:
- Live in the U.S.
- In 9th-12th grade
- Attends a high school that is outside of the home (i.e. not home-schooled or online schooled)
- High school has a consistent start time all 5 days of the week
- Has migraine by International Classification of Headache Disorders criteria
- Can read and write in English
Exclusion criteria: NA
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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).
|
The time that the school starts
|
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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).
|
The time that the school starts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Headache days per month
Time Frame: Last 30 days
|
How many headache days experienced in the last month
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Last 30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hours of sleep on typical school night
Time Frame: Last 30 days
|
Respondent's estimate of hours of sleep on a typical school night
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Last 30 days
|
|
Typical bedtime on school night
Time Frame: Last 30 days
|
Respondent's estimate of typical bedtime on school night
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Last 30 days
|
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Typical wake up time on a school day
Time Frame: Last 30 days
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Respondent's estimate of typical wakeup time on a school day
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Last 30 days
|
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Number of missed breakfasts in a typical school week
Time Frame: Last 30 days
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Respondent's estimate of how many times they miss breakfast in a typical school week
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Last 30 days
|
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Acute headache medication days per month
Time Frame: Last 30 days
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How many days per month respondent uses acute headache medication
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Last 30 days
|
|
PedMIDAS (Pediatric Migraine Disability Assessment Scale)
Time Frame: Last 90 days
|
Headache related disability score--Total score ranges from 0-246
|
Last 90 days
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amy A Gelfand, MD, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- High School Start Time Study
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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