Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03964181
Other study ID # HS-3155
Secondary ID 75277
Status Completed
Phase
First received
Last updated
Start date April 11, 2017
Est. completion date July 31, 2021

Study information

Verified date September 2022
Source National Jewish Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 118000
Est. completion date July 31, 2021
Est. primary completion date May 31, 2019
Accepts healthy volunteers
Gender All
Age group 8 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - None

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Change in school start times
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.

Locations

Country Name City State
United States National Jewish Health Denver Colorado

Sponsors (1)

Lead Sponsor Collaborator
National Jewish Health

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Meltzer 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. — View Citation

Meltzer 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. — View Citation

Meltzer 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). pii: zsab048. doi: 10.1093/sleep/zsab048. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Typical bedtime and wake time, assessed prior to start time change, and 1 and 2 years after start time change
See also
  Status Clinical Trial Phase
Completed NCT04044495 - Sleep, Rhythms and Risk of Alzheimer's Disease N/A
Recruiting NCT06079853 - Nurse Suicide: Physiologic Sleep Health Promotion Trial N/A
Completed NCT05017974 - Research on Improving Sleep During Pregnancy N/A
Recruiting NCT05206747 - Ottawa Sunglasses at Night for Mania Study N/A
Enrolling by invitation NCT04253054 - Chinese Multi-provincial Cohort Study-Beijing Project
Completed NCT04513743 - Ultra Long-Term Sleep Monitoring Using UNEEG™ Medical 24/7 EEG™ SubQ N/A
Completed NCT03251274 - Bath Machine on Sleep Quality in Nursing Home N/A
Completed NCT04102345 - Lavender vs Zolpidem Sleep Quality During Diagnostic PSG Early Phase 1
Completed NCT03725943 - Comparison of Dreem to Clinical PSG for Sleep Monitoring in Healthy Adults N/A
Active, not recruiting NCT05062161 - Sleep Duration and Blood Pressure During Sleep N/A
Completed NCT04562181 - Consistency Evaluation of the qCON, qNOX Indices and Bispectral Index N/A
Completed NCT05102565 - A Dyadic Telehealth Program for Alzheimer's Patients/Caregivers N/A
Completed NCT05576844 - Ai Youmian (Love Better Sleep) for People Living With HIV N/A
Completed NCT04688099 - Synovial Fluid Sleep Study
Recruiting NCT04171245 - Prescribing Laughter for Sleep and Wellbeing in UAE University Students N/A
Completed NCT03758768 - The Effects of a Blue Monochromatic Light Intervention on Evening-type Individuals' Sleep and Circadian Rhythms N/A
Completed NCT03163498 - Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Completed NCT04093271 - Investigating the Efficacy of Rest-ZZZ Formula in Healthy Participants With Difficulty Falling Asleep or Staying a Sleep Phase 1
Completed NCT03673397 - The Acute Effect of Aerobic Exercise on Sleep in Patients With Depression N/A
Completed NCT04120363 - Trial of Testosterone Undecanoate for Optimizing Performance During Military Operations Phase 4