Trial Outcomes & Findings for Delayed Sleep Timing in Teens Study (NCT NCT03806296)
NCT ID: NCT03806296
Last Updated: 2025-08-26
Results Overview
Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)
COMPLETED
NA
142 participants
T1 (1 Week), T2 (2 Weeks)
2025-08-26
Participant Flow
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).
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.
Participant milestones
| Measure |
Early/Middle Sleep Timing
Participants who reported a weekend bedtime \<1AM.
This group completed the T1 Baseline (aka Laboratory) phase and Longitudinal phase.
Participants were asked to complete the following during a 7-day T1 Baseline phase:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph At the conclusion of the 7 days, participants were asked to complete an overnight visit in the sleep lab.
After T1, participants entered the Longitudinal phase, during which they completed periodic self-report follow-ups through the life of the grant (every 2 months for the first 6 months, biannual after that up through 60 months).
|
Late Sleep Timing - Control
Participants who reported a weekend bedtime ≥ 1 AM. This group completed the T1 Baseline (aka Laboratory) phase, T2 Post-Manipulation (aka Experimental) phase, and Longitudinal phase.
Participants were asked to complete the following during a 7-day T1 Baseline phase:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph≥ At the conclusion of the 7 days, participants were asked to complete an overnight visit in the sleep lab.
Next, the participants completed the 2-week T2 Post-Manipulation phase, during which they were asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph At the conclusion of the \~2 weeks, participants were asked to complete an overnight visit in the sleep lab.
After T2, participants entered the Longitudinal phase, during which they completed periodic self-report follow-ups through the life of the grant (every 2 months for the first 6 months, biannual after that up through 60 months).
|
Late Sleep Timing - Manipulation
Participants who reported a weekend bedtime ≥ 1 AM. This group completed the T1 Baseline (aka Laboratory) phase, T2 Post-Manipulation (aka Experimental) phase, and Longitudinal phase.
Participants were asked to complete the following during a 7-day T1 Baseline phase:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph≥ At the conclusion of the 7 days, participants were asked to complete an overnight visit in the sleep lab.
Next, the participants completed the 2-week T2 Post-Manipulation phase, during which they were asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph At the conclusion of the \~2 weeks, participants were asked to complete an overnight visit in the sleep lab.
After T2, participants entered the Longitudinal phase, during which they completed periodic self-report follow-ups through the life of the grant (every 2 months for the first 6 months, biannual after that up through 60 months).
|
|---|---|---|---|
|
T1: Laboratory: 1 Week
STARTED
|
56
|
42
|
44
|
|
T1: Laboratory: 1 Week
COMPLETED
|
42
|
40
|
40
|
|
T1: Laboratory: 1 Week
NOT COMPLETED
|
14
|
2
|
4
|
|
T2: Experimental: 2 Weeks
STARTED
|
0
|
40
|
40
|
|
T2: Experimental: 2 Weeks
COMPLETED
|
0
|
38
|
38
|
|
T2: Experimental: 2 Weeks
NOT COMPLETED
|
0
|
2
|
2
|
|
Longitudinal Phase: 6 - 60 Months
STARTED
|
42
|
40
|
38
|
|
Longitudinal Phase: 6 - 60 Months
COMPLETED
|
37
|
30
|
25
|
|
Longitudinal Phase: 6 - 60 Months
NOT COMPLETED
|
5
|
10
|
13
|
Reasons for withdrawal
| Measure |
Early/Middle Sleep Timing
Participants who reported a weekend bedtime \<1AM.
This group completed the T1 Baseline (aka Laboratory) phase and Longitudinal phase.
Participants were asked to complete the following during a 7-day T1 Baseline phase:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph At the conclusion of the 7 days, participants were asked to complete an overnight visit in the sleep lab.
After T1, participants entered the Longitudinal phase, during which they completed periodic self-report follow-ups through the life of the grant (every 2 months for the first 6 months, biannual after that up through 60 months).
|
Late Sleep Timing - Control
Participants who reported a weekend bedtime ≥ 1 AM. This group completed the T1 Baseline (aka Laboratory) phase, T2 Post-Manipulation (aka Experimental) phase, and Longitudinal phase.
Participants were asked to complete the following during a 7-day T1 Baseline phase:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph≥ At the conclusion of the 7 days, participants were asked to complete an overnight visit in the sleep lab.
Next, the participants completed the 2-week T2 Post-Manipulation phase, during which they were asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph At the conclusion of the \~2 weeks, participants were asked to complete an overnight visit in the sleep lab.
After T2, participants entered the Longitudinal phase, during which they completed periodic self-report follow-ups through the life of the grant (every 2 months for the first 6 months, biannual after that up through 60 months).
|
Late Sleep Timing - Manipulation
Participants who reported a weekend bedtime ≥ 1 AM. This group completed the T1 Baseline (aka Laboratory) phase, T2 Post-Manipulation (aka Experimental) phase, and Longitudinal phase.
Participants were asked to complete the following during a 7-day T1 Baseline phase:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph≥ At the conclusion of the 7 days, participants were asked to complete an overnight visit in the sleep lab.
Next, the participants completed the 2-week T2 Post-Manipulation phase, during which they were asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph At the conclusion of the \~2 weeks, participants were asked to complete an overnight visit in the sleep lab.
After T2, participants entered the Longitudinal phase, during which they completed periodic self-report follow-ups through the life of the grant (every 2 months for the first 6 months, biannual after that up through 60 months).
|
|---|---|---|---|
|
T1: Laboratory: 1 Week
Withdrawal by Subject
|
6
|
1
|
3
|
|
T1: Laboratory: 1 Week
Lost to Follow-up
|
7
|
1
|
1
|
|
T1: Laboratory: 1 Week
Investigator withdrawn due to ineligibility learned post-enrollment.
|
1
|
0
|
0
|
Baseline Characteristics
Delayed Sleep Timing in Teens Study
Baseline characteristics by cohort
| Measure |
Early/Middle Sleep Timing
n=42 Participants
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.
|
Late Sleep Timing - Control
n=40 Participants
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.
|
Late Sleep Timing - Manipulation
n=40 Participants
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.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
17.4 Age (in years)
STANDARD_DEVIATION 0.64 • n=5 Participants
|
17.6 Age (in years)
STANDARD_DEVIATION 0.55 • n=7 Participants
|
17.4 Age (in years)
STANDARD_DEVIATION 0.74 • n=5 Participants
|
17.5 Age (in years)
STANDARD_DEVIATION 0.65 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
113 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
96 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.
Total Sleep Time as determined by wrist actigraphy data (averaged across weekdays during 1 week of T1 and during 2 weeks of T2)
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=42 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=39 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Weekday Sleep Duration - Actigraphy
T1
|
6.309 Number of hours
Standard Deviation 1.07
|
5.866 Number of hours
Standard Deviation 0.963
|
5.880 Number of hours
Standard Deviation 0.765
|
|
Weekday Sleep Duration - Actigraphy
T2
|
—
|
5.845 Number of hours
Standard Deviation 0.817
|
6.554 Number of hours
Standard Deviation 0.801
|
PRIMARY outcome
Timeframe: 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.
Circadian Timing as determined by dim light melatonin onset (DLMO) assessed during saliva sampling using the 4pg/ml threshold.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=38 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=36 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Circadian Timing - Dim Light Melatonin Onset
T1
|
20.707 Clock Time (24-hour clock)
Standard Deviation 1.112
|
21.849 Clock Time (24-hour clock)
Standard Deviation 1.395
|
21.789 Clock Time (24-hour clock)
Standard Deviation 1.228
|
|
Circadian Timing - Dim Light Melatonin Onset
T2
|
—
|
22.038 Clock Time (24-hour clock)
Standard Deviation 1.501
|
21.194 Clock Time (24-hour clock)
Standard Deviation 1.355
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=38 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=36 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=39 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Circadian Alignment
T1
|
6.071 Hours
Standard Deviation 1.111
|
5.798 Hours
Standard Deviation 1.142
|
5.937 Hours
Standard Deviation 1.071
|
|
Circadian Alignment
T2
|
—
|
5.910 Hours
Standard Deviation 1.463
|
5.586 Hours
Standard Deviation 1.243
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=42 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=38 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Reward Motivation (Behavioral)
T1
|
32.609 Adjusted Average Number of pumps
Standard Deviation 13.274
|
37.696 Adjusted Average Number of pumps
Standard Deviation 15.364
|
34.448 Adjusted Average Number of pumps
Standard Deviation 14.416
|
|
Reward Motivation (Behavioral)
T2
|
—
|
43.961 Adjusted Average Number of pumps
Standard Deviation 13.508
|
34.117 Adjusted Average Number of pumps
Standard Deviation 11.244
|
PRIMARY outcome
Timeframe: 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.
Accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on No-Go trials following an incongruent Go cue
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=42 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=37 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Behavioral Inhibition
T1
|
0.910 Proportion accurate responses out of 1
Standard Deviation 0.108
|
0.891 Proportion accurate responses out of 1
Standard Deviation 0.096
|
0.846 Proportion accurate responses out of 1
Standard Deviation 0.124
|
|
Behavioral Inhibition
T2
|
—
|
0.861 Proportion accurate responses out of 1
Standard Deviation 0.131
|
0.829 Proportion accurate responses out of 1
Standard Deviation 0.155
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=37 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=32 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=34 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Neural Correlates of Reward Anticipation
T1
|
0.040 percent signal change
Standard Deviation 0.086
|
0.027 percent signal change
Standard Deviation 0.123
|
0.074 percent signal change
Standard Deviation 0.132
|
|
Neural Correlates of Reward Anticipation
T2
|
—
|
0.007 percent signal change
Standard Deviation 0.125
|
0.030 percent signal change
Standard Deviation 0.087
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=37 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=33 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=35 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Neural Correlates of Reward Receipt
T1
|
-0.009 percent signal change
Standard Deviation 0.103
|
-0.028 percent signal change
Standard Deviation 0.135
|
-0.019 percent signal change
Standard Deviation 0.139
|
|
Neural Correlates of Reward Receipt
T2
|
—
|
0.009 percent signal change
Standard Deviation 0.100
|
-0.008 percent signal change
Standard Deviation 0.074
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=26 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=27 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=35 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Neural Correlates of Impulse Control
T1
|
0.047 percent signal change
Standard Deviation 0.080
|
0.066 percent signal change
Standard Deviation 0.063
|
0.070 percent signal change
Standard Deviation 0.072
|
|
Neural Correlates of Impulse Control
T2
|
—
|
0.049 percent signal change
Standard Deviation 0.071
|
0.054 percent signal change
Standard Deviation 0.078
|
PRIMARY outcome
Timeframe: 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.
Days of cannabis use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=42 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Cannabis Use
|
2.167 Days of use
Standard Deviation 5.708
|
3.200 Days of use
Standard Deviation 10.115
|
2.148 Days of use
Standard Deviation 6.928
|
PRIMARY outcome
Timeframe: 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.
Days of alcohol use based on timeline followback interview administered during baseline interview during consent/diagnostic interview visit.
Outcome measures
| Measure |
Early/Middle Sleep Timing
n=42 Participants
Participants who report a weekend bedtime \<1AM.
|
Late Sleep Timing - Control
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Control group for the Experimental protocol (T2)
During the Experimental protocol, the Control group was asked to adhere to the following:
\- Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
Late Sleep Timing - Manipulation
n=40 Participants
Group Definition: Participants who report a weekend bedtime \>= 1AM and were randomized to the Manipulation group for the Experimental protocol (T2)
During the Experimental protocol, the Manipulation group was asked to adhere to the following:
* Sleep scheduling--advance bedtime by 1.5 hours ( + sleep duration)
* Decrease evening blue light exposure via blue blocker goggles (2 h before bed)
* Increase morning bright light exposure via bright light goggles (30 m after rise)
* Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
|
|---|---|---|---|
|
Alcohol Use
|
0.381 Days of use
Standard Deviation 0.697
|
1.275 Days of use
Standard Deviation 2.961
|
1.325 Days of use
Standard Deviation 2.515
|
Adverse Events
Early/Middle Sleep Timing
Late Sleep Timing - Control
Late Sleep Timing - Manipulation
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brant Hasler, PhD
University of Pittsburgh School of Medicine
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place