Teen Sleep Health Study

Sponsor
Rush University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT04087603
Collaborator
(none)
52
1
2
28.2
1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Weekend Morning Bright Light & Early Bedtime
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
52 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Masking Description:
Group assignment is impossible to blind.
Primary Purpose:
Treatment
Official Title:
Teen School-Night Sleep Extension: An Intervention Targeting the Circadian System
Actual Study Start Date :
Jan 5, 2017
Actual Primary Completion Date :
May 12, 2019
Actual Study Completion Date :
May 12, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in circadian phase [Saturday evening before and Saturday evening after the 2-week intervention]

    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).

  2. Change in sleep duration [2-week baseline period and 2-week intervention period]

    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.

  3. Change in daytime sleepiness [Saturday before and Saturday after the 2-week intervention]

    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.

  4. Change in daytime vigilance/attention [Saturday before and Saturday after the 2-week intervention]

    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.

  5. Change in inhibitory control [Saturday before and Saturday after the 2-week intervention]

    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.

  6. Change in cognitive processing [Saturday before and Saturday after the 2-week intervention]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years to 17 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 14- 17 years; enrolled in high school; lives in or near Chicago, IL
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rush University Medical Center Chicago Illinois United States 60612

Sponsors and Collaborators

  • Rush University Medical Center

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Stephanie Crowley, Associate Professor, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT04087603
Other Study ID Numbers:
  • R01HL112756
First Posted:
Sep 12, 2019
Last Update Posted:
Sep 19, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stephanie Crowley, Associate Professor, Rush University Medical Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 19, 2019