SleepNCT03964181
Changing School Start Times: Impact on Student, Family, Teacher, and Community Health
An observational study of Sleep, run by National Jewish Health at 1 site in United States.
Trial summary
Sleep is not an optional luxury, but a fundamental biological need, essential for health and well-being. Insufficient sleep is a significant public health issue, with 69% of adolescents in America obtaining less than the minimum requirement of 8 hours of sleep per night. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Sleep
- What is being tested?
- Change in school start times
- How many people
- 118,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2017to 31 Jul 2021
- 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 8 years and older
- All sexes
- Child, Adult, Older adult
Study population: Participants were drawn from the Cherry Creek School District outside of Denver, Colorado
Who may be able to join
- Students in grades 3-12 enrolled in the school district
- Parents of students in grades K-12 enrolled in the school district
- School-based teachers and staff in grades K-12 in the school district
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Sleep is not an optional luxury, but a fundamental biological need, essential for health and well-being. Insufficient sleep is a significant public health issue, with 69% of adolescents in America obtaining less than the minimum requirement of 8 hours of sleep per night. Early school start times has been identified as the most significant and modifiable factor that restricts sleep duration in adolescents. The American Academy of Pediatrics recommended in 2014 that all middle and high schools start no earlier than 8:30 a.m., yet few school districts have implemented this change. In fall 2017, the Cherry Creek School District, a diverse district of almost 55,000 students outside Denver, changed school start times. Although previous studies have shown increased sleep duration, decreased daytime sleepiness, and improved academics following start time changes for secondary students, there remains an urgent need to understand how this policy impacts health and well-being for all students, including youth in elementary school. Recognizing that students are part of a complex system that includes parents, school staff, and the community, this observational study will be a multi-year, broad-based evaluation that includes key stakeholders, multiple sources of quantitative data (i.e., surveys, academic records, district nursing electronic health records), contextual qualitative data (i.e., open-ended surveys and focus groups), and community-based outcomes (i.e., data on vehicle crashes and juvenile crimes). The primary hypothesis is that later school start times will have a positive impact on middle and high school students sleep and health outcomes, while earlier school start times will have a neutral impact on elementary school students sleep and health outcomes.
- Conditions
- Sleep
- Being tested
- Change in school start times
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in school start timesOther
Elementary start times changed from 9:00 a.m. to 8:00 a.m.; middle school start times changed from 8:00 a.m. to 8:50 a.m.; high school start times changed from 7:10 a.m. to 8:20 a.m.
| Study group | Role | What they receive |
|---|---|---|
| Students Grades 3-12 | Not described Receives: Other: Change in school start times | |
| Parents of Students Grades K-12 | Not described Receives: Other: Change in school start times | |
| School Based Teachers and Staff Grades K-12 | Not described Receives: Other: Change in school start times |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in sleep duration from before start time change to 1 and 2 years after start time change
Reported sleep from bedtime to wake time
Measured: Typical bedtime and wake time, assessed prior to start time change, and 1 and 2 years after start time change
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2019
- Study start11 Apr 2017
- Primary completion31 May 2019
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 118,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Jewish Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Meltzer, National Jewish Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03964181
- Sponsor's protocol ID
- HS-3155
- Other IDs
- 75277
- Status last verified
- Sep 2022
- First submitted
- 22 May 2019
- Last updated
- 29 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Meltzer LJ, McNally J, Plog AE, Siegfried SA. Engaging the community in the process of changing school start times: experience of the Cherry Creek School District. Sleep Health. 2017 Dec;3(6):472-478. doi: 10.1016/j.sleh.2017.08.005. Epub 2017 Oct 16.
PubMed 29157642Meltzer LJ, Wahlstrom KL, Plog AE, Strand MJ. Changing school start times: impact on sleep in primary and secondary school students. Sleep. 2021 Jul 9;44(7):zsab048. doi: 10.1093/sleep/zsab048.
PubMed 33855446Meltzer LJ, Wahlstrom KL, Plog AE, McNally J. Impact of changing school start times on parent sleep. Sleep Health. 2022 Feb;8(1):130-134. doi: 10.1016/j.sleh.2021.08.003. Epub 2021 Oct 9.
PubMed 34642123Meltzer LJ, Plog AE, Wahlstrom KL, Strand MJ. Biology vs. ecology: a longitudinal examination of sleep, development, and a change in school start times. Sleep Med. 2022 Feb;90:176-184. doi: 10.1016/j.sleep.2022.01.003. Epub 2022 Jan 10.
PubMed 35182977
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing School Start Times: Impact on Student, Family, Teacher, and Community Health
- ClinicalTrials.gov ID
- NCT03964181
- Acronym / sponsor ID
- HS-3155
- Conditions
- Sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 118,000 participants (actual)
- Lead sponsor
- National Jewish HealthUniversity, hospital or other
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 28 May 2019 (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.
Sleep is not an optional luxury, but a fundamental biological need, essential for health and well-being. Insufficient sleep is a significant public health issue, with 69% of adolescents in America obtaining less than the minimum requirement of 8 hours of sleep per night. Early school start times has been identified as the most significant and modifiable factor that restricts sleep duration in adolescents. The American Academy of Pediatrics recommended in 2014 that all middle and high schools start no earlier than 8:30 a.m., yet few school districts have implemented this change. In fall 2017, the Cherry Creek School District, a diverse district of almost 55,000 students outside Denver, changed school start times. Although previous studies have shown increased sleep duration, decreased daytime sleepiness, and improved academics following start time changes for secondary students, there remains an urgent need to understand how this policy impacts health and well-being for all students, including youth in elementary school. Recognizing that students are part of a complex system that includes parents, school staff, and the community, this observational study will be a multi-year, broad-based evaluation that includes key stakeholders, multiple sources of quantitative data (i.e., surveys, academic records, district nursing electronic health records), contextual qualitative data (i.e., open-ended surveys and focus groups), and community-based outcomes (i.e., data on vehicle crashes and juvenile crimes). The primary hypothesis is that later school start times will have a positive impact on middle and high school students sleep and health outcomes, while earlier school start times will have a neutral impact on elementary school students sleep and health outcomes.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Students Grades 3-12 | – | Other: Change in school start times |
| Parents of Students Grades K-12 | – | Other: Change in school start times |
| School Based Teachers and Staff Grades K-12 | – | Other: Change in school start times |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants were drawn from the Cherry Creek School District outside of Denver, Colorado
Key inclusion criteria (3 listed)
- Students in grades 3-12 enrolled in the school district
- Parents of students in grades K-12 enrolled in the school district
- School-based teachers and staff in grades K-12 in the school district
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Change in school start timesElementary start times changed from 9:00 a.m. to 8:00 a.m.; middle school start times changed from 8:00 a.m. to 8:50 a.m.; high school start times changed from 7:10 a.m. to 8:20 a.m. | Other | Parents of Students Grades K-12, School Based Teachers and Staff Grades K-12, Students Grades 3-12 |
Primary outcome
Change in sleep duration from before start time change to 1 and 2 years after start time change
Time frame: Typical bedtime and wake time, assessed prior to start time change, and 1 and 2 years after start time change
Reported sleep from bedtime to wake time
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 29 Sep 2022.
- Results publication: PubMed 29157642Meltzer LJ, McNally J, Plog AE, Siegfried SA. Engaging the community in the process of changing school start times: experience of the Cherry Creek School District. Sleep Health. 2017 Dec;3(6):472-478. doi: 10.1016/j.sleh.2017.08.005. Epub 2017 Oct 16.
- Results publication: PubMed 33855446Meltzer LJ, Wahlstrom KL, Plog AE, Strand MJ. Changing school start times: impact on sleep in primary and secondary school students. Sleep. 2021 Jul 9;44(7):zsab048. doi: 10.1093/sleep/zsab048.
- Results publication: PubMed 34642123Meltzer LJ, Wahlstrom KL, Plog AE, McNally J. Impact of changing school start times on parent sleep. Sleep Health. 2022 Feb;8(1):130-134. doi: 10.1016/j.sleh.2021.08.003. Epub 2021 Oct 9.
- Results publication: PubMed 35182977Meltzer LJ, Plog AE, Wahlstrom KL, Strand MJ. Biology vs. ecology: a longitudinal examination of sleep, development, and a change in school start times. Sleep Med. 2022 Feb;90:176-184. doi: 10.1016/j.sleep.2022.01.003. Epub 2022 Jan 10.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sleep, run by National Jewish Health 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 3 inclusion and 1 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 29 Sep 2022. 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?
Change in sleep duration from before start time change to 1 and 2 years after start time change (time frame: Typical bedtime and wake time, assessed prior to start time change, and 1 and 2 years after start time change). 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 NCT03964181, which also lists 4 linked publications.
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 29 Sep 2022; AzTrials last refreshed its copy on 7 Nov 2026.