Clinical trial NCT04285307: The Effect of Sleep Extension in Teenage Girls at a College Preparatory High School
Official title: The Effect of Sleep Extension in Teenage Girls at a College Preparatory High School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Hygiene
Sleep
Keywords: Actigraphy
Sleep Extension
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: Divine Savior Holy Angels High School
name: Children's Hospital and Health System Foundation, Wisconsin
First posted: 2020-02-26
Enrollment: 35
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Change in Stress Levels
timeFrame: Week 0 (before actigraphy) and Week 6 (after both actigraphy watch courses)
Secondary outcomes:
measure: Change in Physical Fitness
timeFrame: 6 months (end of August to end of February)
measure: Sleepiness
timeFrame: 6 weeks, 2 before intervention and 4 after
measure: Total Sleep Time
timeFrame: 6 weeks, 2 before intervention and 4 after
measure: Sleep Latency
timeFrame: 6 weeks, 2 before intervention and 4 after
measure: Academic performance
timeFrame: First semester 4 months (August 19th, 2019 - December 20th, 2019)
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Divine Savior Holy Angels High School
state: Wisconsin
Study officials:
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