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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04285307
• Other study ID #: 1176849
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 13, 2018
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2021
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 their sleep hygiene.

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

Description:

A. PURPOSE OF THE STUDY

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

B. 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: August 1, 2022
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. Subjects and/or parent/guardian unable to read, understand or speak English

2. Subjects unable to undergo fitness testing

3. Subjects who are pregnant or become pregnant during the course of the study

Related Conditions & MeSH terms

• Sleep
• Sleep Hygiene

Intervention

Behavioral:
• Sleep Hygiene tips
Students receive a packet of information on how to improve their sleep habits and hygiene.

Locations

Country	Name	City	State
United States	Divine Savior Holy Angels High School	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Children's Hospital and Health System Foundation, Wisconsin, Divine Savior Holy Angels High School

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Natale V, Plazzi G, Martoni M. Actigraphy in the assessment of insomnia: a quantitative approach. Sleep. 2009 Jun;32(6):767-71. — View Citation

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

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Stress Levels	Perceived Stress Scale (PSS); 10 questions, scores between 0-4; higher score shows higher stress levels	Week 0 (before actigraphy) and Week 6 (after both actigraphy watch courses)
Secondary	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	6 months (end of August to end of February)
Secondary	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	6 weeks, 2 before intervention and 4 after
Secondary	Total Sleep Time	Difference in total sleep time before and after sleep extension intervention	6 weeks, 2 before intervention and 4 after
Secondary	Sleep Latency	Difference in sleep latency before and after sleep extension intervention	6 weeks, 2 before intervention and 4 after
Secondary	Academic performance	Grade point average (GPA); 0.0-4.0 scale, higher is better	First semester 4 months (August 19th, 2019 - December 20th, 2019)