Excessive Daytime SomnolenceSTaRtSNCT04049682
Start Times and Restful Sleep
An observational study of Excessive Daytime Somnolence and Sleep Deprivation, run by University of California, San Diego at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Daytime Somnolence, Sleep Deprivation
- What is being tested?
- Delayed School Start Time
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2019to Dec 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 13 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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
Who may be able to join
- 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
Who cannot join
- Under 13 years old
- Over 19 years old
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, San Diego
San Diego, California, 92093
Francis Parker High School
San Diego, California, 92111
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Excessive Daytime Somnolence, Sleep Deprivation
- Being tested
- Delayed School Start Time
- Keywords
- Sleep, Sleep Deprivation, School
- Medical subject headings
- Disorders of Excessive Somnolence, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed School Start TimeBehavioural
Francis Parker High School implemented 45-minute later school start time.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: Delayed School Start Time |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Activity
Physical activity levels in the form of step counts from FitBit data over two distinct 3-month periods
Measured: 6 months
Sleep Duration
Bedtimes and sleep durations using FitBit data over two distinct 3-month periods
Measured: 6 months
Secondary outcomes (2)
Subjective Sleepiness
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'.
Measured: 20 minutes
Response Time
Reaction times measured in milliseconds using the psychomotor vigilance test.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study startSep 2019 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Study never recruited subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Daytime SomnolenceStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Robert Owens, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049682
- Sponsor's protocol ID
- 191306
- Acronym
- STaRtS
- Status last verified
- Jul 2020
- First submitted
- 6 Aug 2019
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STaRtS: Start Times and Restful Sleep
- ClinicalTrials.gov ID
- NCT04049682
- Acronym / sponsor ID
- STaRtS / 191306
- Conditions
- Excessive Daytime Somnolence, Sleep Deprivation
- Keywords
- Sleep, Sleep Deprivation, School
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study never recruited subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Sep 2019 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Aug 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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre Time-change | – | –Daily activity, sleep duration, subjective sleepiness, and response time before change in school start time |
| Post Time-change | – | Behavioral: Delayed School Start TimeDaily activity, sleep duration, subjective sleepiness, and response time after change in school start time |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Under 13 years old
- Over 19 years old
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 |
|---|---|---|
| Delayed School Start TimeFrancis Parker High School implemented 45-minute later school start time. | Behavioural | Post Time-change |
Primary outcome
Daily Activity
Time frame: 6 months
Physical activity levels in the form of step counts from FitBit data over two distinct 3-month periods
Sleep Duration
Time frame: 6 months
Bedtimes and sleep durations using FitBit data over two distinct 3-month periods
2 secondary outcomes
Subjective Sleepiness
Time frame: 20 minutes
Response Time
Time frame: 20 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- 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.
Robert Owens, MD principal investigator
UCSD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Daytime Somnolence and Sleep Deprivation, run by University of California, San Diego at 2 sites 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 2 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: withdrawn, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was withdrawn before enrolling participants, so there are no results.
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?
Daily Activity (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2020.