Teen Sleep Health Study

NCT04087603 | Completed

• 1 other identifier: R01HL112756
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sleep Disorders, Circadian Rhythm; Adolescent Behavior

Keywords

Circadian rhythms; Sleep; Adolescence

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Weekend Morning Bright Light & Early Bedtime

EXPERIMENTAL

* 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

Healthy Control

NO INTERVENTION

\- Sleep as usual at home for 2 weeks

Interventions

Weekend Morning Bright Light & Early Bedtime BEHAVIORAL

Weekend Morning Bright Light & Early Bedtime

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Related Publications (1)

• Crowley SJ, Velez SL, Killen LG, Cvengros JA, Fogg LF, Eastman CI. Extending weeknight sleep of delayed adolescents using weekend morning bright light and evening time management. Sleep. 2023 Jan 11;46(1):zsac202. doi: 10.1093/sleep/zsac202.

  PMID: 36006948 DERIVED

MeSH Terms

Conditions

Sleep Disorders, Circadian Rhythm; Adolescent Behavior

Condition Hierarchy (Ancestors)

Chronobiology Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Occupational Diseases; Mental Disorders; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Group assignment is impossible to blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2019
• First Posted: September 12, 2019
• Study Start: January 5, 2017
• Primary Completion: May 12, 2019
• Study Completion: May 12, 2019
• Last Updated: September 19, 2019

Record last verified: 2019-09

Locations

US (1)