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Start Times and Restful Sleep (STaRtS)

2020年7月13日 更新者:Robert L. Owens、University of California, San Diego

STaRtS: Start Times and Restful Sleep

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.

研究概览

详细说明

Visit 1: Fall 2019, Enrollment and baseline measurements After obtaining informed consent from the parent and assent from the student, baseline data will be obtained. Visit #1 will take place on campus during free periods, lunch or immediately after school and would not interfere with studies. This will include basic demographic data (age, gender) and a questionnaire asking about their average commute time and type, their afterschool activities, as well as an Epworth Sleepiness scale and validated survey of chronotype (Horne-Ostenberg). Subjects will also undergo a standard 10-minute Psychomotor Vigilance Test (PVT) and be given a FitBit. Investigators will assist them in installing the FitBit app and a screen time app, Moment for on their phones. Including the informational part of this visit, enrollment and questionnaires will take about an hour.

Of note, neither the app nor the FitBit will collect geolocalized data. The app does not track and record content, but only gives us the number of minutes per day the phone is on. There is no cost for the app nor does it use cellular data or wireless connection. The data will be collected during study visits rather than in real time.

At this meeting, subjects will be instructed to wear their FitBits as much as possible, especially while sleeping or during physical activity, and to make sure that the screen time app is working on their phone. The investigators recognize that the students will not likely be able to wear their FitBit at all times, but investigators will ask them to use their devices as much as possible. Periodic email communications will be sent out every other week reminding them to continue wearing their FitBit.

Visit 2: Winter 2019, 12-week time point and FitBit collection. Investigators plan to end the study period on December 19, 2019, the Thursday before students go on winter vacation. Depending on when investigators start the study, this would be about 12 weeks after the beginning of the study period (including a non-school week and a few long weekends). At this visit, investigators will repeat all study procedures from visit 1. Investigators will collect the FitBits, facilitate the export of screen time data and allow them to delete the Moment app on their phones. Subjects will be instructed to look for further communications from us at the beginning of the next year. This visit will likely take about 30 minutes.

Visit 3: Fall 2020, Start time change, FitBit redistribution. Francis Parker will switch to a 45 minute later start time for the 2020-21 school year. On the same week of school as the first visit, investigators will hold a meeting in which subjects will repeat all study procedures as in visit 1 Subjects will be given the same FitBit as subjects used in the last study period. Investigators will supervise them as subjects install the FitBit and Moment app on their phones. This visit will likely take about 30 minutes.

At this meeting, subjects will again be instructed to wear their FitBits as much as possible, especially while sleeping or during physical activity, and to make sure that the screen time app is working on their phone. The Periodic email communications will again be sent out every week reminding them to continue wearing their FitBit.

Visit 4: Winter 2020, 12 week time point, final collection. Again, the study period will end on the Thursday before the students go on winter vacation, about 12 weeks from the beginning of the study period. Subjects will fill out another Epworth Sleepiness scale and undergo a PVT, and undergo a brief survey on their perception of how the start time change has affected their sleep and well-being. Investigators will collect FitBits and instruct subjects to delete the Moment app on their phones.

Data Collection and Analysis Epworth and PVT data will be collected and scored according to the standard guidelines for each battery, and our own surveys will be aggregated and analyzed. Moment data is exported as a CSV file which can be opened with Excel.

The information from the FitBit devices will be obtained via Fitabase (a FitBit partner) , which is a data platform designed to aggregate information from FitBits for research purposes. The FitBit device collects and stores information about an individual's activity; this information is automatically synced (e.g., up to every 10-20 minutes when the smartphone's Bluetooth capability is enabled) with the user's smartphone via the FitBit smartphone application using Bluetooth technology. This data is concurrently transmitted to FitBit servers. For subjects enrolled in research studies, Fitabase collects the information from the FitBit servers in near real time and aggregates the information. Investigators can access this data using a secure login provided by Fitabase. A document with more detail on Fitabase security is included with this application.

研究类型

观察性的

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • San Diego、California、美国、92093
        • University of California, San Diego
      • San Diego、California、美国、92111
        • Francis Parker High School

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

13年 至 18年 (孩子、成人)

接受健康志愿者

有资格学习的性别

全部

取样方法

概率样本

研究人群

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

描述

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Under 13 years old
  • Over 19 years old

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 观测模型:队列
  • 时间观点:预期

队列和干预

团体/队列
干预/治疗
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
Francis Parker High School implemented 45-minute later school start time.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Daily Activity
大体时间:6 months
Physical activity levels in the form of step counts from FitBit data over two distinct 3-month periods
6 months
Sleep Duration
大体时间:6 months
Bedtimes and sleep durations using FitBit data over two distinct 3-month periods
6 months

次要结果测量

结果测量
措施说明
大体时间
Subjective Sleepiness
大体时间:20 minutes

A subjective measure of daytime sleepiness, measured as an Epworth Sleepiness Score using a questionnaire (Epworth Sleepiness Scale) that combines.

The Epworth Sleepiness Scale (ESS) is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3), their usual chances of dozing off or falling asleep while engaged in eight different activities. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

20 minutes
Response Time
大体时间:20 minutes
Reaction times measured in milliseconds using the psychomotor vigilance test.
20 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Robert Owens, MD、UCSD

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2019年9月1日

初级完成 (预期的)

2021年5月1日

研究完成 (预期的)

2021年12月1日

研究注册日期

首次提交

2019年8月6日

首先提交符合 QC 标准的

2019年8月6日

首次发布 (实际的)

2019年8月8日

研究记录更新

最后更新发布 (实际的)

2020年7月15日

上次提交的符合 QC 标准的更新

2020年7月13日

最后验证

2020年7月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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