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Sleep HygieneNCT04285307

The Effect of Sleep Extension in Teenage Girls at a College Preparatory High School

A study testing Sleep Hygiene tips in people with Sleep Hygiene and Sleep, run by Medical College of Wisconsin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

If teenagers attain the recommended amount of sleep (9-9.5 hours per night), they will feel less stress and have better athletic and academic performance. The investigators will track students sleep patterns before and after a sleep intervention where they are given a packet of sleep tips and encouraged to improve… Read more about this study

Who is it for?
Ages 14 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for
Sleep Hygiene, Sleep
What is being tested?
Sleep Hygiene tips
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
1 siteUnited States
Study dates
13 Apr 2018to 1 Aug 2022
Phase
Interventional
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 14 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 1. Female students age 14-18 yrs (DSHA students ranging from Freshman to Senior year)

Who cannot join

  • Subjects and/or parent/guardian unable to read, understand or speak English
  • Subjects unable to undergo fitness testing
  • Subjects who are pregnant or become pregnant during the course of the study

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Divine Savior Holy Angels High School

    Milwaukee, Wisconsin, 53222

Other trials in United States

About this study

If teenagers attain the recommended amount of sleep (9-9.5 hours per night), they will feel less stress and have better athletic and academic performance.

The investigators will track students sleep patterns before and after a sleep intervention where they are given a packet of sleep tips and encouraged to improve their sleep hygiene.

Outcomes include stress levels, academic/athletic performance, and sleep cycle data from the sleep tracking watch.

Read the detailed description
  1. PURPOSE OF THE STUDY

To determine the effect of sleep extension on stress levels, cognitive function, and fitness in teenage girls.

  1. HYPOTHESIS / SPECIFIC AIMS

If teenagers attain the recommended amount of sleep (9-9.5 hours per night), they will feel less stress and have better athletic and academic performance.

Primary Objective:

  • The investigators will evaluate stress with a validated questionnaire before and after sleep extension (increased total sleep time per night).

Secondary Objectives:

  • The investigators will evaluate physical fitness and endurance with standardized testing before and after sleep extension.
  • The investigators will measure several sleep variables (total sleep time, sleep efficiency, sleep onset latency, sleep-wake cycle pattern, sleepiness) before and after sleep extension.
  • The investigators will evaluate the association between academic performance (Grade Point Average (GPA) and average total sleep time per night.

Intervention:

Sleep extension: Increasing nightly total sleep time (goal of 9-9.5 hours per night) by improving sleep hygiene, daily exercise, etc.

In a prospective cohort study, up to 40 otherwise healthy teenage girls age 14-18 years at DSHA High School will be approached for consent to participate in the study. Upon consent they will complete the Insomnia Severity Index (ISI), Epworth Sleepiness Scale for Children and Adolescents (ESS-ChAD) and Perceived Stress Scale (PSS) questionnaires and will be issued an actigraphy watch to monitor their sleep-wake cycles daily at home for 2 weeks. They will also keep a sleep diary during the study period.

After the 2 weeks of actigraphy, subjects will have the data from the actigraphy watch downloaded and submit their sleep diary. They will be given sleep hygiene recommendations to try to attain 9-9.5 hours of sleep per night (sleep extension), if not already sleeping this amount. They will then be given a different actigraphy watch to wear and another sleep diary to log their total sleep time for 4 more weeks.

After the 4 weeks, the actigraphy watch will be returned, the actigraphy data will be downloaded and the sleep diary data will be collected. Subjects will complete the ESS-ChAD and PSS upon conclusion of the study. Subjects will be offered a report of their sleep and activity data after completing the sleep extension period. If there is a gap of more than 4 weeks between actigraphy use and the second fitness test, the investigators will ask participants to complete another 1-week sleep diary prior to testing. All study activities except downloading the actigraphy watch data will occur at Divine Savior Holy Angels High School (DSHA).

Conditions
Sleep Hygiene, Sleep
Being tested
Sleep Hygiene tips
Keywords
Actigraphy, Sleep Extension
Medical subject headings
Sleep Hygiene

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sleep Hygiene tipsBehavioural

    Students receive a packet of information on how to improve their sleep habits and hygiene.

Study groups in NCT04285307
Study groupRoleWhat they receive
Study groupExperimentalStudy group
Receives: Behavioral: Sleep Hygiene tips

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Stress Levels

    Perceived Stress Scale (PSS); 10 questions, scores between 0-4; higher score shows higher stress levels

    Measured: Week 0 (before actigraphy) and Week 6 (after both actigraphy watch courses)

Secondary outcomes (5)

  1. Change in Physical Fitness

    Standardized PACER (Progressive Aerobic Cardiovascular Endurance Run) testing; administered in the Fall and Spring of each school year; a series of timed runs that get progressively faster; Out of 25 laps, higher score is better with more laps completed

    Measured: 6 months (end of August to end of February)

  2. Sleepiness

    Difference in sleepiness before and after sleep extension intervention. Measured with the Epworth Sleepiness Scale for Children and Adolescents (ESS-CHAD); scale of 0 to 3; higher score means more likely to fall asleep in a given situation

    Measured: 6 weeks, 2 before intervention and 4 after

  3. Total Sleep Time

    Difference in total sleep time before and after sleep extension intervention

    Measured: 6 weeks, 2 before intervention and 4 after

  4. Sleep Latency

    Difference in sleep latency before and after sleep extension intervention

    Measured: 6 weeks, 2 before intervention and 4 after

  5. Academic performance

    Grade point average (GPA); 0.0-4.0 scale, higher is better

    Measured: First semester 4 months (August 19th, 2019 - December 20th, 2019)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2020
  2. Study start13 Apr 2018
  3. Primary completion1 Aug 2022
  4. Study completion1 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04285307
Sponsor's protocol ID
1176849
Status last verified
Dec 2021
First submitted
1 Jan 2020
Last updated
13 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carskadon MA, Harvey K, Duke P, Anders TF, Litt IF, Dement WC. Pubertal changes in daytime sleepiness. 1980. Sleep. 2002 Sep 15;25(6):453-60. No abstract available.

    PubMed 12224838

  • Wolfson AR, Carskadon MA. Sleep schedules and daytime functioning in adolescents. Child Dev. 1998 Aug;69(4):875-87.

    PubMed 9768476

  • Lee YJ, Park J, Kim S, Cho SJ, Kim SJ. Academic performance among adolescents with behaviorally induced insufficient sleep syndrome. J Clin Sleep Med. 2015 Jan 15;11(1):61-8. doi: 10.5664/jcsm.4368.

    PubMed 25515277

  • Mah CD, Mah KE, Kezirian EJ, Dement WC. The effects of sleep extension on the athletic performance of collegiate basketball players. Sleep. 2011 Jul 1;34(7):943-50. doi: 10.5665/SLEEP.1132.

    PubMed 21731144

  • Schwartz J, Simon RD Jr. Sleep extension improves serving accuracy: A study with college varsity tennis players. Physiol Behav. 2015 Nov 1;151:541-4. doi: 10.1016/j.physbeh.2015.08.035. Epub 2015 Sep 1.

    PubMed 26325012

  • Adolescent Sleep Working Group; Committee on Adolescence; Council on School Health. School start times for adolescents. Pediatrics. 2014 Sep;134(3):642-9. doi: 10.1542/peds.2014-1697.

    PubMed 25156998

  • National Sleep Foundation. Eight major obstacles to delaying school start times. http://sleepfoundation.org/sleep-news/eight-major-obstacles-delaying-school-start-times.

  • Janssen KC, Phillipson S, O'Connor J, Johns MW. Validation of the Epworth Sleepiness Scale for Children and Adolescents using Rasch analysis. Sleep Med. 2017 May;33:30-35. doi: 10.1016/j.sleep.2017.01.014. Epub 2017 Feb 12.

    PubMed 28449902

  • Kanady JC, Drummond SP, Mednick SC. Actigraphic assessment of a polysomnographic-recorded nap: a validation study. J Sleep Res. 2011 Mar;20(1 Pt 2):214-22. doi: 10.1111/j.1365-2869.2010.00858.x.

    PubMed 20626612

  • Natale V, Plazzi G, Martoni M. Actigraphy in the assessment of insomnia: a quantitative approach. Sleep. 2009 Jun;32(6):767-71. doi: 10.1093/sleep/32.6.767.

    PubMed 19544753

Questions about this trial

What is this clinical trial studying?

A study testing Sleep Hygiene tips in people with Sleep Hygiene and Sleep, run by Medical College of Wisconsin 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 1 inclusion and 3 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 13 Apr 2025. 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 Stress Levels (time frame: Week 0 (before actigraphy) and Week 6 (after both actigraphy watch courses)). 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 NCT04285307, which also lists 10 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 13 Apr 2025.

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