MigraineNCT03766412
High School Start Time and Teen Migraine Frequency
An observational study of Migraine, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine
- What is being tested?
- High School start time
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2018to 15 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: U.S. High school students with migraine
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco, (UCSF)
San Francisco, California, 94158
About this study
Official title: 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.
Read the 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.
- Conditions
- Migraine
- Being tested
- High School start time
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High School start timeOther
The time that the school starts
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: High School start time | |
| 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). Receives: Other: High School start time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Headache days per month
How many headache days experienced in the last month
Measured: Last 30 days
Secondary outcomes (6)
Hours of sleep on typical school night
Respondent's estimate of hours of sleep on a typical school night
Measured: Last 30 days
Typical bedtime on school night
Respondent's estimate of typical bedtime on school night
Measured: Last 30 days
Typical wake up time on a school day
Respondent's estimate of typical wakeup time on a school day
Measured: Last 30 days
Number of missed breakfasts in a typical school week
Respondent's estimate of how many times they miss breakfast in a typical school week
Measured: Last 30 days
Acute headache medication days per month
How many days per month respondent uses acute headache medication
Measured: Last 30 days
PedMIDAS (Pediatric Migraine Disability Assessment Scale)
Headache related disability score--Total score ranges from 0-246
Measured: Last 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2018
- Study start1 Oct 2018
- Primary completion15 Oct 2018
- Study completion15 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy A Gelfand, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03766412
- Sponsor's protocol ID
- High School Start Time Study
- Status last verified
- Dec 2018
- First submitted
- 11 Oct 2018
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gelfand AA, Pavitt S, Greene K, Szperka CL, Irwin S, Grimes B, Allen IE. High School Start Time and Migraine Frequency in High School Students. Headache. 2019 Jul;59(7):1024-1031. doi: 10.1111/head.13535. Epub 2019 Apr 24.
PubMed 31016722
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High School Start Time and Adolescent Migraine Frequency
- ClinicalTrials.gov ID
- NCT03766412
- Acronym / sponsor ID
- High School Start Time Study
- Conditions
- Migraine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 Oct 2018 (actual)
- First posted
- 6 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| School start time 8:30 AM or later | – | Other: High School start timeThese 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). |
| School start time earlier than 8:30 | – | Other: High School start timeThese 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- U.S. High school students with migraine
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High School start timeThe time that the school starts | Other | School start time 8:30 AM or later, School start time earlier than 8:30 |
Primary outcome
Headache days per month
Time frame: Last 30 days
How many headache days experienced in the last month
6 secondary outcomes
Hours of sleep on typical school night
Time frame: Last 30 days
Typical bedtime on school night
Time frame: Last 30 days
Typical wake up time on a school day
Time frame: Last 30 days
Number of missed breakfasts in a typical school week
Time frame: Last 30 days
Acute headache medication days per month
Time frame: Last 30 days
PedMIDAS (Pediatric Migraine Disability Assessment Scale)
Time frame: Last 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Derived from this study: PubMed 31016722Gelfand AA, Pavitt S, Greene K, Szperka CL, Irwin S, Grimes B, Allen IE. High School Start Time and Migraine Frequency in High School Students. Headache. 2019 Jul;59(7):1024-1031. doi: 10.1111/head.13535. Epub 2019 Apr 24.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy A Gelfand, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Headache days per month (time frame: Last 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03766412, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.