Teen Sleep Health Study

Teen School-Night Sleep Extension: An Intervention Targeting the Circadian System

The objective of this project is to develop an effective, yet feasible strategy to extend school-night sleep duration of older adolescents.

Study Overview

• Status: Completed
• Conditions: Adolescent Behavior; Sleep Disorders, Circadian Rhythm
• Intervention / Treatment: Behavioral: Weekend Morning Bright Light & Early Bedtime

Detailed Description

The investigators are developing and testing a feasible behavioral intervention to increase school-night sleep duration by shifting the circadian system earlier and providing a time management plan for after-school activities in youngsters between 14 and 17 years and enrolled in high school. This study tests morning bright light and a school-night time management plan to facilitate earlier bedtimes to increase sleep duration. Circadian phase, sleep, neurobehavioral functioning and mood are measured before and immediately after the 2-week intervention and compared to a control group. Long-term effectiveness, adherence, and acceptability are also examined in a 3-week extension study. These data will provide evidence-based treatment strategies for delayed and sleep-restricted adolescents, and acceptability of and adherence to the treatment in this age group.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 17 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 14- 17 years; enrolled in high school; lives in or near Chicago, IL

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Weekend Morning Bright Light & Early Bedtime; Assigned a set sleep schedule for 2 weeks; Receives evening time management goals to help facilitate scheduled bedtime; Receives morning bright light from 2 light boxes (Phillips EnergyLights) on two weekend mornings.	Behavioral: Weekend Morning Bright Light & Early Bedtime
No Intervention: Healthy Control; - Sleep as usual at home for 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in circadian phase	A change in the timing of the circadian system is measured using the Dim Light Melatonin Onset (DLMO), the most reliable measure of circadian phase in humans. Salivary melatonin is measured every 30 minutes in dim light and assayed using standard commercially-available radioimmunoassay (RIA) kits. The time at which melatonin rises above a 4 pg/mL threshold is the DLMO. The DLMO is measured before starting the intervention ("baseline DLMO") and then again after completing the 2-week intervention ("final DLMO"). The primary outcome is DLMO phase shift (baseline DLMO - final DLMO).	Saturday evening before and Saturday evening after the 2-week intervention
Change in sleep duration	Sleep duration is measured from a wrist actigraph (Actiwatch Spectrum) worn on the non-dominant wrist throughout the month-long study. For the first 2 weeks, participants sleep as usual at home (baseline). During the last two weeks, the experimental group shifts their bedtime earlier and the control group does not. The main outcome is the change in average sleep duration from baseline to intervention weeks.	2-week baseline period and 2-week intervention period
Change in daytime sleepiness	Daytime sleepiness is derived from the Stanford Sleepiness scale (1=Feeling active, vital, alert, or wide awake; 7= no longer fighting sleep, sleep onset soon; having dream-like thoughts) administered as part of the Automated Neuropsychological Assessment Metrics (ANAM). Participants complete the ANAM on the Saturday preceding the intervention period and again on a Saturday after the intervention is over. The ANAM is administered 3 times throughout the day.	Saturday before and Saturday after the 2-week intervention
Change in daytime vigilance/attention	Vigilance/attention is derived from simple reaction time test administered as part of the Automated Neuropsychological Assessment Metrics (ANAM). Participants complete the ANAM on the Saturday preceding the intervention period and again on a Saturday after the intervention is over. The ANAM is administered 3 times throughout the day. Outcomes include number of lapses (responses < 500 ms) and median reaction time. Changes in the the number of lapses and median reaction times are the main outcomes.	Saturday before and Saturday after the 2-week intervention
Change in inhibitory control	Participants complete executive tests from the Delis-Kaplan Executive Function System (D-KEFS) on the Saturday preceding the intervention period and again on a Saturday after the intervention is over. The D-KEFS is a battery of executive-function tests that assess a broad range of higher-level cognitive skills. Inhibitory control is derived from the D-KEFS Color-Word Interference Test. Changes in completion time on this test is the main outcome.	Saturday before and Saturday after the 2-week intervention
Change in cognitive processing	Participants complete executive tests from the Delis-Kaplan Executive Function System (D-KEFS) on the Saturday preceding the intervention period and again on a Saturday after the intervention is over. The D-KEFS is a battery of executive-function tests that assess a broad range of higher-level cognitive skills. Cognitive processing and monitoring is derived from the Design Fluency test. Changes in completion time and changes in the number of errors are the main outcomes.	Saturday before and Saturday after the 2-week intervention

Collaborators and Investigators

• Sponsor: Rush University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2017
• Primary Completion (Actual): May 12, 2019
• Study Completion (Actual): May 12, 2019

Study Registration Dates

• First Submitted: September 9, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (Actual): September 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 16, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Sleep; Adolescence; Circadian rhythms
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Occupational Diseases; Chronobiology Disorders; Sleep Wake Disorders; Sleep Disorders, Circadian Rhythm
• Other Study ID Numbers: R01HL112756 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The investigators will share the research data in publications. The sample size from this study allows for publishing the raw de-identified data, either in a table within the main text of the publication or in an appendix. The necessary precautions will be taken to ensure data are not linked to individual participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No