Start Times and Restful Sleep

NCT04049682 | Withdrawn

• 1 other identifier: 191306
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate the efficacy of later school start times in increasing student sleep, and examine the association between later start times and physical activity, screen time, and commute time. Subjects will wear a FitBit activity tracker wristband for two separate 3-month periods (the year before and the year after the Francis Parker High School start time change in the Fall of 2020) and be advised to wear it as much as possible, especially while sleeping or performing physical activity. At the beginning and end of each study period (at 4 occasions), subjects will fill out a few short, non-invasive surveys about their commute, after-school activities, sleepiness, and preferences for morning or evening, and perform the non-invasive psychomotor vigilance test to measure alertness.

Conditions

Excessive Daytime Somnolence; Sleep Deprivation

Keywords

Sleep; Sleep Deprivation; School

Outcome Measures

Primary Outcomes (2)

• Daily Activity

  Physical activity levels in the form of step counts from FitBit data over two distinct 3-month periods

  6 months

• Sleep Duration

  Bedtimes and sleep durations using FitBit data over two distinct 3-month periods

  6 months

Secondary Outcomes (2)

• Subjective Sleepiness

  20 minutes

• Response Time

  20 minutes

Study Arms (2)

Pre Time-change

Daily activity, sleep duration, subjective sleepiness, and response time before change in school start time

Post Time-change

Daily activity, sleep duration, subjective sleepiness, and response time after change in school start time

Behavioral: Delayed School Start Time

Interventions

Delayed School Start Time BEHAVIORAL

Francis Parker High School implemented 45-minute later school start time.

Post Time-change

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

40 High school students (freshmen, sophomores, and juniors during the 2019-20 school year) primarily younger than 18 years old, enrolled at Francis Parker High School

You may qualify if:

• Age 12 or older.
• Enrolled as a freshman, sophomore, or junior at Francis Parker High School.
• In possession of a smartphone compatible with the mobile applications used for the study

You may not qualify if:

• Under 13 years old
• Over 19 years old

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (2)

University of California, San Diego

San Diego, California, 92093, United States

Location

Francis Parker High School

San Diego, California, 92111, United States

Location

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Sleep Deprivation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert Owens, MD

  UCSD

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: September 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)