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Teen Sleep Health Study

Primary Purpose

Sleep Disorders, Circadian Rhythm, Adolescent Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekend Morning Bright Light & Early Bedtime
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorders, Circadian Rhythm focused on measuring Circadian rhythms, Sleep, Adolescence

Eligibility Criteria

14 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Weekend Morning Bright Light & Early Bedtime

Healthy Control

Arm Description

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.

- Sleep as usual at home for 2 weeks

Outcomes

Primary Outcome Measures

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).
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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 9, 2019
Last Updated
September 16, 2019
Sponsor
Rush University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04087603
Brief Title
Teen Sleep Health Study
Official Title
Teen School-Night Sleep Extension: An Intervention Targeting the Circadian System
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
January 5, 2017 (Actual)
Primary Completion Date
May 12, 2019 (Actual)
Study Completion Date
May 12, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rush University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorders, Circadian Rhythm, Adolescent Behavior
Keywords
Circadian rhythms, Sleep, Adolescence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Group assignment is impossible to blind.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Weekend Morning Bright Light & Early Bedtime
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control
Arm Type
No Intervention
Arm Description
- Sleep as usual at home for 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
Weekend Morning Bright Light & Early Bedtime
Primary Outcome Measure Information:
Title
Change in circadian phase
Description
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).
Time Frame
Saturday evening before and Saturday evening after the 2-week intervention
Title
Change in sleep duration
Description
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.
Time Frame
2-week baseline period and 2-week intervention period
Title
Change in daytime sleepiness
Description
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.
Time Frame
Saturday before and Saturday after the 2-week intervention
Title
Change in daytime vigilance/attention
Description
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.
Time Frame
Saturday before and Saturday after the 2-week intervention
Title
Change in inhibitory control
Description
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.
Time Frame
Saturday before and Saturday after the 2-week intervention
Title
Change in cognitive processing
Description
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.
Time Frame
Saturday before and Saturday after the 2-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 14- 17 years; enrolled in high school; lives in or near Chicago, IL Exclusion Criteria: -
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing 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.

Learn more about this trial

Teen Sleep Health Study

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