An interventional study of Weekend Morning Bright Light & Early Bedtime in Sleep Disorders, Circadian Rhythm and Adolescent Behavior, sponsored by Rush University Medical Center. Completed at 1 site in United States. Open to participants aged 14 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-19.
Sponsored by Rush University Medical Center · Not applicable, Interventional, and Treatment
The objective of this project is to develop an effective, yet feasible strategy to extend school-night sleep duration of older adolescents.
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.
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 52 is below the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Rush University Medical Center is the lead sponsor of 394 studies on the registry; 61 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
-
* 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
- Sleep as usual at home for 2 weeks
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Saturday before and Saturday after the 2-week intervention
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — 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.
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Rush University Medical Center