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Teen Sleep Health Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04087603
Enrollment
52
Registered
2019-09-12
Start date
2017-01-05
Completion date
2019-05-12
Last updated
2019-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Behavior, Sleep Disorders, Circadian Rhythm

Keywords

Circadian rhythms, Sleep, Adolescence

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.

Interventions

BEHAVIORALWeekend Morning Bright Light & Early Bedtime

Sponsors

Rush University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Group assignment is impossible to blind.

Eligibility

Sex/Gender
ALL
Age
14 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Change in circadian phaseSaturday evening before and Saturday evening after the 2-week interventionA 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 duration2-week baseline period and 2-week intervention periodSleep 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 sleepinessSaturday before and Saturday after the 2-week interventionDaytime 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/attentionSaturday before and Saturday after the 2-week interventionVigilance/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 controlSaturday before and Saturday after the 2-week interventionParticipants 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 processingSaturday before and Saturday after the 2-week interventionParticipants 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 11, 2026