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Delayed Sleep Timing in Teens Study

Delayed Sleep Phase and Risk for Adolescent Substance Use

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03806296
Enrollment
142
Registered
2019-01-16
Start date
2018-12-03
Completion date
2024-11-30
Last updated
2025-08-26

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

Conditions

Delayed Sleep Phase

Keywords

sleep, circadian, adolescence, substance use, reward, impulse control

Brief summary

This study will (1) comprehensively characterize the substance use disorder (SUD) risk profile associated with adolescent Delayed Sleep Phase (DSP), and (2) probe whether SUD risk is diminished by altering sleep/circadian timing.

Detailed description

Mounting evidence indicates that delayed sleep phase (DSP) may confer risk for adolescent substance use (SU) and SUDs. However, the exact nature of this link and the mechanisms underlying it remain unclear. Circadian misalignment, a mismatch between late sleep hours and early school start times, is a compelling potential contributor to elevated SU in adolescent DSP with plausible neurobehavioral mechanisms. The investigators hypothesize that DSP-associated circadian misalignment decreases impulse control and increases reward sensitivity, thereby increasing SUD risk. This study will, for the first time, (1) comprehensively characterize the SUD risk profile associated with adolescent DSP, and (2) probe whether SUD risk is diminished by altering sleep/circadian timing. The study will assess both established markers of SUD risk and putative neurobehavioral mechanisms (impulsivity and reward sensitivity). Specifically, the investigators will employ a comprehensive, multi-method approach to examining DSP's role in SUD risk, combining laboratory, experimental, and longitudinal studies. The investigators will recruit a sample of 150 eleventh and twelfth graders (16-19 y/o), divided between 100 DSP and 50 normal phase teens. The investigators will focus on cannabis and alcohol use given their prevalent use in adolescents and evident links to DSP. In the laboratory study, the investigators will compare a group of DSP adolescents to a group of normal phase adolescents on behavioral and neuroimaging (fMRI) tasks tapping impulsivity and reward sensitivity, as well as a circadian phase assessment. In the experimental study, the investigators will probe whether stabilizing circadian phase in the DSP group (n=100) by using sleep scheduling and chronotherapeutic approaches (i.e., dim light in the evening and bright light in the morning) improves sleep and neurobehavioral function relevant to SUD risk. NOTE: When this ClinicalTrials.gov protocol was initially submitted, there were some mistakes made. The initial submission focused only on the Experimental study, which thus only included the DSP group (aka Late Sleep Timing group), and thus out the Laboratory study along with the normal phase group (aka Early/Middle Sleep Timing group). At that time, we also only listed a limited range of the primary outcomes listed in the funded grant, inadvertently leaving out several primary outcomes (weekday sleep duration - actigraph, circadian timing - dim light melatonin onset, neural correlates of reward receipt, and baseline cannabis and alcohol use). Finally, we mistakenly listed cannabis use from the Longitudinal protocol as a secondary outcome when it was actually an exploratory outcome in the funded grant, and thus we removed it.

Interventions

Participants will wear Re-Timer bright glasses for 30 minutes each morning

Participants will wear tinted glasses that block blue wavelength light for 2 hours before bed

Participants will advance their weekday bedtime and maintain their weekday risetime on weekends

Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Pittsburgh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

This study combines Laboratory, Experimental, and Longitudinal protocols. The study includes 2 initial groups (Early/Middle Sleep Timing and Late Sleep Timing) that all complete the initial Laboratory (baseline) protocol. The Late Sleep participants are also randomized to complete one of two arms (Manipulation or Control) in the Experimental (intervention) protocol. The Early/Mid Sleep group does not complete the Experimental protocol. Finally, participants are also follow-up assessments through the life of the grant in the Longitudinal protocols.

Eligibility

Sex/Gender
ALL
Age
16 Years to 19 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 16-19 years * Currently in 11th or 12th grade and enrolled in a traditional high-school; or cyber school with synchronous classes (not home-schooled) * Physically and psychiatrically healthy, as determined by instruments described below * Provision of written informed consent and assent Additional inclusion criterion for Experimental protocol * Meets operational definition of delayed sleep phase (DSP; weekend bedtime ≥1 AM)

Exclusion criteria

* Significant or unstable acute or chronic medical conditions * Past or current bipolar disorder or psychotic disorder * Past or current substance use disorder other than alcohol use disorder or cannabis use disorder * Past month recreational drug use other than alcohol, cannabis, and nicotine * Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder * Medications that interfere with sleep and/or reward function (antidepressants, and stimulants prescribed for ADHD are permitted) * Conditions that would interfere with the MRI procedures (e.g., non-removal ferromagnetic devices)

Design outcomes

Primary

MeasureTime frameDescription
Weekday Sleep Duration - ActigraphyT1 (1 Week), T2 (2 Weeks)Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)
Circadian Timing - Dim Light Melatonin OnsetOvernight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.Circadian Timing as determined by dim light melatonin onset (DLMO) assessed during saliva sampling using the 4pg/ml threshold.
Circadian AlignmentOvernight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday. Based on DLMO assessed on weeknight lab overnight visit, and including the two nights of actigraphy data prior to the lab visit.Circadian alignment is operationalized as the interval between the dim light melatonin onset (DLMO) and sleep midpoint based on the prior two nights of actigraphy data.
Reward Motivation (Behavioral)Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.Adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button. The adjusted average only includes non-burst trials.
Behavioral InhibitionOvernight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue
Neural Correlates of Reward AnticipationOvernight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.Activation within the reward network during the Monetary Incentive Delay task. Specifically, activation is defined as bold signal in regions of the reward network (from NeuroSynth) on reward anticipation trials (large reward) versus neutral (no money) trials. Higher values represent increased reactivity to reward, as compared to neutral trials.
Neural Correlates of Reward ReceiptOvernight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.Monetary Incentive Delay Task: Win Outcome vs No Win contrast within the reward network (from Neurosynth). Higher values represent increased reactivity to reward wins, as compared to neutral trials.
Neural Correlates of Impulse ControlOvernight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.Activation within the Executive Control Network during the Stop Signal Task. Specifically, activation is defined as bold signal in regions of the Executive Control Network on unsuccessful Stop trials versus successful Go trials. Higher values represent increased activity to unsuccessful Stop versus successful Go trials.
Cannabis UseDays of cannabis use in 3 months prior to baseline.Days of cannabis use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.
Alcohol Use3 months prior to baseline, based on timeline followback interview.Days of alcohol use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.

Countries

United States

Participant flow

Recruitment details

Participants were recruited from the surrounding community using flyers, postings on Pitt+Me (a registry for clinical and translational science research) and Read Green, word-of-mouth referrals, social media (Facebook/Instagram, Snapchat, YouTube, Spotify), Peach Jar (an online source for distributing flyers to schools), bus or church advertisements, local teen agencies, and school recruitment (contacting guidance counselors, teachers, and administrative employees).

Pre-assignment details

The 142 enrolled participants include individuals who consented to the study, were randomized to a group, and completed a limited battery of baseline assessments during that consent/diagnostic interview visit, but did not necessarily continue on into the Laboratory (Baseline/T1) protocol.

Participants by arm

ArmCount
Early/Middle Sleep Timing
Group definition: Participants who report a weekend bedtime \<1AM. Also known as the Laboratory protocol. Participants are asked to complete the following during a 7-day baseline period: \- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph At the conclusion of the 7 days, participants are asked to complete an overnight visit in the sleep lab.
42
Late Sleep Timing - Control
Group definition: Participants who reported a weekend bedtime ≥ 1 AM. Participants were randomized into either the Manipulation or Control Group. Also known as the Laboratory Protocol. Participants are asked to complete the following during a 7-day baseline period: \- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph≥ At the conclusion of the 7 days, participants are asked to complete an overnight visit in the sleep lab.
40
Late Sleep Timing - Manipulation
Group definition: Participants who reported a weekend bedtime ≥ 1 AM. Participants were randomized into either the Manipulation or Control Group. Also known as the Laboratory Protocol. Participants are asked to complete the following during a 7-day baseline period: \- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph≥ At the conclusion of the 7 days, participants are asked to complete an overnight visit in the sleep lab.
40
Total122

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
T1: Laboratory: 1 WeekInvestigator withdrawn due to ineligibility learned post-enrollment.100
T1: Laboratory: 1 WeekLost to Follow-up711
T1: Laboratory: 1 WeekWithdrawal by Subject613

Baseline characteristics

CharacteristicEarly/Middle Sleep TimingLate Sleep Timing - ControlLate Sleep Timing - ManipulationTotal
Age, Continuous17.4 Age (in years)
STANDARD_DEVIATION 0.64
17.6 Age (in years)
STANDARD_DEVIATION 0.55
17.4 Age (in years)
STANDARD_DEVIATION 0.74
17.5 Age (in years)
STANDARD_DEVIATION 0.65
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants4 Participants3 Participants9 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
40 Participants36 Participants37 Participants113 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants2 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
9 Participants6 Participants4 Participants19 Participants
Race (NIH/OMB)
More than one race
1 Participants3 Participants1 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
32 Participants29 Participants35 Participants96 Participants
Sex: Female, Male
Female
28 Participants22 Participants26 Participants76 Participants
Sex: Female, Male
Male
14 Participants18 Participants14 Participants46 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 420 / 400 / 40
other
Total, other adverse events
0 / 420 / 400 / 40
serious
Total, serious adverse events
0 / 420 / 400 / 40

Outcome results

Primary

Alcohol Use

Days of alcohol use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.

Time frame: 3 months prior to baseline, based on timeline followback interview.

Population: The numbers in this section include all participants who consented, were determined eligible and interested, and started the Laboratory (T1) protocol.

ArmMeasureValue (MEAN)Dispersion
Early/Middle Sleep TimingAlcohol Use0.381 Days of useStandard Deviation 0.697
Late Sleep Timing - ControlAlcohol Use1.275 Days of useStandard Deviation 2.961
Late Sleep Timing - ManipulationAlcohol Use1.325 Days of useStandard Deviation 2.515
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary alcohol use outcome (yes/no in the past 3 months), accounting for age and sex.p-value: 0.46195% CI: [0.704, 2.171]Poisson GLM with robust standard error
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a negative binomial GLM to test the effect of group (Early/Mid vs Late) on days of alcohol use, accounting for age and sex.p-value: 0.00795% CI: [1.36, 7.9]negative binomial glm
Primary

Behavioral Inhibition

Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue

Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Population: The numbers displayed in this section include the usable behavioral computer task data collected at T1 overnight visits. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingBehavioral InhibitionT10.910 Proportion accurate responses out of 1Standard Deviation 0.108
Late Sleep Timing - ControlBehavioral InhibitionT10.891 Proportion accurate responses out of 1Standard Deviation 0.096
Late Sleep Timing - ControlBehavioral InhibitionT20.861 Proportion accurate responses out of 1Standard Deviation 0.131
Late Sleep Timing - ManipulationBehavioral InhibitionT10.846 Proportion accurate responses out of 1Standard Deviation 0.124
Late Sleep Timing - ManipulationBehavioral InhibitionT20.829 Proportion accurate responses out of 1Standard Deviation 0.155
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: 0.02495% CI: [0.07, 0.94]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.p-value: 0.6695% CI: [-0.55, 0.35]Mixed Models Analysis
Primary

Cannabis Use

Days of cannabis use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.

Time frame: Days of cannabis use in 3 months prior to baseline.

Population: The numbers in this section include all participants who consented, were determined eligible and interested, and started the Laboratory (T1) protocol.

ArmMeasureValue (MEAN)Dispersion
Early/Middle Sleep TimingCannabis Use2.167 Days of useStandard Deviation 5.708
Late Sleep Timing - ControlCannabis Use3.200 Days of useStandard Deviation 10.115
Late Sleep Timing - ManipulationCannabis Use2.148 Days of useStandard Deviation 6.928
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a Poisson generalized linear model (GLM) to test the effect of group (Early/Mid vs Late) on a binary cannabis use outcome (yes/no in the past 3 months), accounting for age and sex.p-value: 0.4295% CI: [0.374, 1.513]Poisson GLM with robust standard error
Primary

Circadian Alignment

Circadian alignment is operationalized as the interval between the dim light melatonin onset (DLMO) and sleep midpoint based on the prior two nights of actigraphy data.

Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday. Based on DLMO assessed on weeknight lab overnight visit, and including the two nights of actigraphy data prior to the lab visit.

Population: The numbers displayed in this section include the participants with usable data collected during (1) the saliva sampling protocol at T1 overnight visits and (2) the actigraphy protocol in the two nights prior to the T1 visit. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingCircadian AlignmentT16.071 HoursStandard Deviation 1.111
Late Sleep Timing - ControlCircadian AlignmentT15.798 HoursStandard Deviation 1.142
Late Sleep Timing - ControlCircadian AlignmentT25.910 HoursStandard Deviation 1.463
Late Sleep Timing - ManipulationCircadian AlignmentT15.937 HoursStandard Deviation 1.071
Late Sleep Timing - ManipulationCircadian AlignmentT25.586 HoursStandard Deviation 1.243
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: 0.36595% CI: [-0.64, 0.24]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.p-value: 0.06795% CI: [-0.88, 0.03]Mixed Models Analysis
Primary

Circadian Timing - Dim Light Melatonin Onset

Circadian Timing as determined by dim light melatonin onset (DLMO) assessed during saliva sampling using the 4pg/ml threshold.

Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Population: The numbers displayed in this section include the usable data collected during the saliva sampling protocol at T1 overnight visits. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingCircadian Timing - Dim Light Melatonin OnsetT120.707 Clock Time (24-hour clock)Standard Deviation 1.112
Late Sleep Timing - ControlCircadian Timing - Dim Light Melatonin OnsetT121.849 Clock Time (24-hour clock)Standard Deviation 1.395
Late Sleep Timing - ControlCircadian Timing - Dim Light Melatonin OnsetT222.038 Clock Time (24-hour clock)Standard Deviation 1.501
Late Sleep Timing - ManipulationCircadian Timing - Dim Light Melatonin OnsetT121.789 Clock Time (24-hour clock)Standard Deviation 1.228
Late Sleep Timing - ManipulationCircadian Timing - Dim Light Melatonin OnsetT221.194 Clock Time (24-hour clock)Standard Deviation 1.355
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: <0.00195% CI: [0.61, 1.59]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.p-value: <0.00195% CI: [-1.09, -0.43]Mixed Models Analysis
Primary

Neural Correlates of Impulse Control

Activation within the Executive Control Network during the Stop Signal Task. Specifically, activation is defined as bold signal in regions of the Executive Control Network on unsuccessful Stop trials versus successful Go trials. Higher values represent increased activity to unsuccessful Stop versus successful Go trials.

Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Population: The numbers displayed in this section include the usable fMRI task data collected at the T1 visit. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingNeural Correlates of Impulse ControlT10.047 percent signal changeStandard Deviation 0.08
Late Sleep Timing - ControlNeural Correlates of Impulse ControlT10.066 percent signal changeStandard Deviation 0.063
Late Sleep Timing - ControlNeural Correlates of Impulse ControlT20.049 percent signal changeStandard Deviation 0.071
Late Sleep Timing - ManipulationNeural Correlates of Impulse ControlT10.070 percent signal changeStandard Deviation 0.072
Late Sleep Timing - ManipulationNeural Correlates of Impulse ControlT20.054 percent signal changeStandard Deviation 0.078
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: 0.12495% CI: [-0.01, 0.06]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.p-value: 0.92595% CI: [-0.05, 0.06]Mixed Models Analysis
Primary

Neural Correlates of Reward Anticipation

Activation within the reward network during the Monetary Incentive Delay task. Specifically, activation is defined as bold signal in regions of the reward network (from NeuroSynth) on reward anticipation trials (large reward) versus neutral (no money) trials. Higher values represent increased reactivity to reward, as compared to neutral trials.

Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Population: The numbers displayed in this section include the usable fMRI task data collected at the T1 visit. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingNeural Correlates of Reward AnticipationT10.040 percent signal changeStandard Deviation 0.086
Late Sleep Timing - ControlNeural Correlates of Reward AnticipationT10.027 percent signal changeStandard Deviation 0.123
Late Sleep Timing - ControlNeural Correlates of Reward AnticipationT20.007 percent signal changeStandard Deviation 0.125
Late Sleep Timing - ManipulationNeural Correlates of Reward AnticipationT10.074 percent signal changeStandard Deviation 0.132
Late Sleep Timing - ManipulationNeural Correlates of Reward AnticipationT20.030 percent signal changeStandard Deviation 0.087
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: 0.59295% CI: [-0.03, 0.06]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.p-value: 0.5595% CI: [-0.11, 0.06]Mixed Models Analysis
Primary

Neural Correlates of Reward Receipt

Monetary Incentive Delay Task: Win Outcome vs No Win contrast within the reward network (from Neurosynth). Higher values represent increased reactivity to reward wins, as compared to neutral trials.

Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Population: The numbers displayed in this section include the usable fMRI task data collected at the T1 visit. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingNeural Correlates of Reward ReceiptT1-0.009 percent signal changeStandard Deviation 0.103
Late Sleep Timing - ControlNeural Correlates of Reward ReceiptT1-0.028 percent signal changeStandard Deviation 0.135
Late Sleep Timing - ControlNeural Correlates of Reward ReceiptT20.009 percent signal changeStandard Deviation 0.1
Late Sleep Timing - ManipulationNeural Correlates of Reward ReceiptT1-0.019 percent signal changeStandard Deviation 0.139
Late Sleep Timing - ManipulationNeural Correlates of Reward ReceiptT2-0.008 percent signal changeStandard Deviation 0.074
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: 0.5595% CI: [-0.07, 0.04]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.p-value: 0.55695% CI: [-0.1, 0.06]Mixed Models Analysis
Primary

Reward Motivation (Behavioral)

Adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button. The adjusted average only includes non-burst trials.

Time frame: Overnight visits at end of T1 (1 Week) and T2 (2 Weeks). Always occurred on a Wednesday or Thursday.

Population: The numbers displayed in this section include the usable behavioral computer task data collected at T1 overnight visits. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingReward Motivation (Behavioral)T132.609 Adjusted Average Number of pumpsStandard Deviation 13.274
Late Sleep Timing - ControlReward Motivation (Behavioral)T137.696 Adjusted Average Number of pumpsStandard Deviation 15.364
Late Sleep Timing - ControlReward Motivation (Behavioral)T243.961 Adjusted Average Number of pumpsStandard Deviation 13.508
Late Sleep Timing - ManipulationReward Motivation (Behavioral)T134.448 Adjusted Average Number of pumpsStandard Deviation 14.416
Late Sleep Timing - ManipulationReward Motivation (Behavioral)T234.117 Adjusted Average Number of pumpsStandard Deviation 11.244
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: 0.23495% CI: [-2.18, 8.82]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoint, and sex.p-value: 0.01895% CI: [-11.25, -1.06]Mixed Models Analysis
Primary

Weekday Sleep Duration - Actigraphy

Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)

Time frame: T1 (1 Week), T2 (2 Weeks)

Population: The numbers displayed in this section include the usable actigraph data collected for participants during T1. Early/Mid Sleep group only assessed at T1.

ArmMeasureGroupValue (MEAN)Dispersion
Early/Middle Sleep TimingWeekday Sleep Duration - ActigraphyT16.309 Number of hoursStandard Deviation 1.07
Late Sleep Timing - ControlWeekday Sleep Duration - ActigraphyT15.866 Number of hoursStandard Deviation 0.963
Late Sleep Timing - ControlWeekday Sleep Duration - ActigraphyT25.845 Number of hoursStandard Deviation 0.817
Late Sleep Timing - ManipulationWeekday Sleep Duration - ActigraphyT15.880 Number of hoursStandard Deviation 0.765
Late Sleep Timing - ManipulationWeekday Sleep Duration - ActigraphyT26.554 Number of hoursStandard Deviation 0.801
Comparison: For these Aim 1 analyses comparing the Early/Middle vs Late Sleep groups, the Late Sleep-Control and Late Sleep-Manipulation were combined into a single Late Sleep group. We used a linear regression model to test the effect of group (Early/Mid vs Late) on each a priori outcome, accounting for age and sex.p-value: 0.01895% CI: [-0.77, -0.07]Regression, Linear
Comparison: For Aim 2, this mixed effect model tested the effect of group (Control vs Manipulation) on changes in each a priori outcome, accounting for group, timepoints, and sex.p-value: 0.00195% CI: [0.28, 1.07]Mixed Models Analysis

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026