Sleep Disorders, Circadian RhythmNCT04087603
Teen Sleep Health Study
A study testing Weekend Morning Bright Light & Early Bedtime in people with Sleep Disorders, Circadian Rhythm and Adolescent Behavior, run by Rush University Medical Center at 1 site in United States.
Trial summary
The objective of this project is to develop an effective, yet feasible strategy to extend school-night sleep duration of older adolescents. Read more about this study
- Who is it for?
- Ages 14 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Circadian Rhythm, Adolescent Behavior
- What is being tested?
- Weekend Morning Bright Light & Early Bedtime
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jan 2017to 12 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 14- 17 years; enrolled in high school; lives in or near Chicago, IL
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612
About this study
Official title: Teen School-Night Sleep Extension: An Intervention Targeting the Circadian System
The objective of this project is to develop an effective, yet feasible strategy to extend school-night sleep duration of older adolescents.
Read the 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.
- Being tested
- Weekend Morning Bright Light & Early Bedtime
- Keywords
- Circadian rhythms, Sleep, Adolescence
- Medical subject headings
- Sleep Disorders, Circadian Rhythm, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekend Morning Bright Light & Early BedtimeBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Weekend Morning Bright Light & Early Bedtime |
| Healthy Control | No intervention | - Sleep as usual at home for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Saturday before and Saturday after the 2-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2019
- Study start5 Jan 2017
- Primary completion12 May 2019
- Study completion12 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorders, Circadian RhythmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephanie Crowley, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04087603
- Sponsor's protocol ID
- R01HL112756
- Status last verified
- Sep 2019
- First submitted
- 9 Sep 2019
- Last updated
- 19 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 36006948
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Teen School-Night Sleep Extension: An Intervention Targeting the Circadian System
- ClinicalTrials.gov ID
- NCT04087603
- Acronym / sponsor ID
- R01HL112756
- Keywords
- Circadian rhythms, Sleep, Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 5 Jan 2017 (actual)
- Primary completion
- 12 May 2019 (actual)
- Study completion
- 12 May 2019 (actual)
- First posted
- 12 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekend Morning Bright Light & Early Bedtime | Experimental | Behavioral: 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. |
| Healthy Control | No intervention | –- Sleep as usual at home for 2 weeks |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 14- 17 years; enrolled in high school; lives in or near Chicago, IL
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekend Morning Bright Light & Early Bedtime | Behavioural | Weekend Morning Bright Light & Early Bedtime |
Primary outcome
Change in circadian phase
Time frame: 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).
Change in sleep duration
Time frame: 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.
Change in daytime sleepiness
Time frame: 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.
Change in daytime vigilance/attention
Time frame: 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.
Change in inhibitory control
Time frame: 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.
Change in cognitive processing
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Derived from this study: PubMed 36006948Crowley 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.
- Individual participant dataSharing planned: 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.
Related trials for Sleep Disorders, Circadian Rhythm
Active, not recruiting
Countermeasures to Circadian Misalignment
Circadian Rhythm Sleep Disorder of Shift Work Type, Metabolic Disease
Enrolling by invitationObservational study
Digital Phenotypes for Predicting Depression_Validation
Major Depressive Disorder, Bipolar I Disorder
Not yet recruitingObservational study
Circadian Clock Proteins in Gingival Crevicular Fluid of Individuals With and Without Circadian Rhythm Disruption
Gingivitis, Circadian Rhythm Disruption
Recruiting
Smith Magenis Syndrome and Autism Spectrum Disorders
Smith-Magenis Syndrome, Autism Spectrum Disorder
RecruitingPhase 4
Lemborexant in Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekend Morning Bright Light & Early Bedtime in people with Sleep Disorders, Circadian Rhythm and Adolescent Behavior, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in circadian phase (time frame: Saturday evening before and Saturday evening after the 2-week intervention). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04087603, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2019.