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Experimental Manipulation of Sleep and Circadian Rhythms and the Role Played on Reward Function in Teens (CARRS-P2)

Primary Purpose

Delayed Sleep Phase Syndrome

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Increase morning bright light
Decrease evening blue light
Sleep Scheduling
Monitor sleep, mood, and substance use
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Delayed Sleep Phase Syndrome focused on measuring adolescence, sleep, substance use, reward sensitivity and motivation, circadian phase and alignment, inhibition

Eligibility Criteria

13 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Typically enrolled in a traditional high-school with synchronous learning (in-person or online synchronous learning, but not cyber- or home-schooling) [school closures during the COVID-19 pandemic are an exception to this]
  • Physically and psychiatrically healthy
  • Provision of written informed consent and assent
  • Additional inclusion criterion for Experimental protocol: Meets operational definition of late sleep timing (>11:15PM habitual bedtime)

Exclusion Criteria:

  • History of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly use in the past year
  • Significant or unstable acute or chronic medical conditions
  • Frequent headaches or migraines
  • History of seizures
  • Current serious psychiatric disorder (e.g., depressive disorder, bipolar disorder, eating disorder, psychotic disorder diagnosis, alcohol use disorder or substance use disorder) that would interfere with completion of study procedures
  • Family history of bipolar disorder among first degree relative
  • Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder
  • MRI contraindications (ie, absence of metal in the body, pregnancy, claustrophobia)
  • Pregnancy
  • Medications that increase sensitivity to blue light/photosensitizing medications, including psychiatric neuroleptic drugs, psoralen drugs, antiarrhythmic drugs, etc.
  • Changes to psychotropic medication regimen in the 2 weeks prior to enrollment, and/or major changes to medications during the study protocol
  • If participants have an average bedtime that is later than 3:00AM or an average wake time later than 11:00AM they cannot participate in the study
  • Participants should be EXCLUDED for other sleep disorders that require ongoing treatment
  • Participants should be EXCLUDED for other sleep disorders that cause significant distress or impairment, per DSM 5 criteria in the Sleep SCID.

Sites / Locations

  • Western Psychiatric HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Advance/Extend Manipulation

Control

Arm Description

For ~2 weeks, Advance/Extend participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days will be instructed to: Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration) Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed) Increase morning bright light exposure via bright light goggles (30 min after rise) Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph

Control participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 13 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments, thereby controlling for effort.

Outcomes

Primary Outcome Measures

Change from baseline in sleep duration at 2 weeks
Assessed by 14-day wrist actigraphy
Change from baseline in Sleep timing at 2 weeks
Assessed by 14-day wrist actrigraphy
Change from baseline in Circadian alignment at 2 weeks
This is measured as the interval between dim light melatonin onset and midsleep.
Change from baseline in behavioral reward motivation at 2 weeks
Assessed by adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in which participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button.
Change from baseline in behavioral inhibition at 2 weeks
Assessed by accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on go trials with no/go target
Change from baseline in neural correlates of impulse control at 2 weeks
This outcome will be measured during the Stop Signal Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the Executive Control Network, specifically, activation is defined as bold signal in regions of the Executive Control Network (particularly the inferior frontal gyrus) on correct Stop trials versus correct Go trials.
Change from baseline in neural correlates of reward anticipation at 2 weeks
This outcome will be measured during the Money Incentive Delay Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the reward network, specifically, activation is defined as bold signals in regions of the reward network (particularly the ventral striatum) on reward anticipation trials versus no money trials.

Secondary Outcome Measures

Caffeine use
Assessed by self-report
Substance use
Substance use on Time Line Follow Back interview. Specifically, the frequency (# of days) of substance use (yes/no) in the past 6 months.

Full Information

First Posted
March 8, 2021
Last Updated
August 2, 2023
Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT04792697
Brief Title
Experimental Manipulation of Sleep and Circadian Rhythms and the Role Played on Reward Function in Teens
Acronym
CARRS-P2
Official Title
Center for Adolescent Reward, Rhythms and Sleep Project 2
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
March 31, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Adolescence is a time of heightened reward sensitivity and greater impulsivity. On top of this, many teenagers experience chronic sleep deprivation and misalignment of their circadian rhythms due to biological shifts in their sleep/wake patterns paired with early school start times. Many studies find that this increases the risk for substance use (SU). However, what impact circadian rhythm and sleep disruption either together or independently have on the neuronal circuitry that controls reward and cognition, or if there are interventions that might help to modify these disruptions is unknown. Project 2 (P2) of the CARRS center will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs.
Detailed Description
Substance use (SU) and substance use disorders (SUD) pose devastating health, financial, and societal costs. The incidence of SU and SUDs increases across adolescence, making this sensitive developmental period one of both heightened risk-and heightened opportunity for prevention and intervention. However, to develop effective interventions investigators need to identify novel and modifiable risk factors and mechanisms for SUD. Sleep and circadian rhythm disturbances are such risk factors, and the reward system, with its increasing sensitivity during adolescence, provides a plausible mechanistic substrate. The focus on sleep, circadian rhythms, and reward system function is particularly salient given the extensive, parallel development of these systems during adolescence, and the plausible linkages between sleep and circadian rhythms, reward function, and SUD risk. Late sleep timing, short sleep duration and circadian misalignment are associated with increased substance use in teenagers and young adults. The central hypothesis of the Center for Adolescent Reward, Rhythms and Sleep (CARRS) is that adolescent development acts on underlying sleep and circadian traits to modify homeostatic sleep drive, circadian phase, and circadian alignment, which in turn impact cortico-limbic functions critical to SU risk (e.g., reward and cognitive control). Investigators further hypothesize that specific manipulations of sleep and circadian rhythms during adolescence will affect reward responsivity and cognitive control in either positive or negative directions. These manipulations will provide experimental support for our model, and proof of concept for novel clinical interventions to reduce the risk of SU and SUDs. Most previous studies have examined individual components of circadian rhythms, sleep, and reward function in adolescence. Project 2 (P2) of CARRS will test an innovative and mechanistic model of brain circuitry that uses multi-method approaches, takes a developmental perspective, and incorporates key sleep and reward constructs. Most notably, P2 improves upon past observational work by testing an experimental intervention that manipulates sleep and circadian rhythms to directly examine its impact on reward function and cognitive control. P2 will study 150 adolescents (age 13-15, 50% female) across two key sleep phenotypes: early sleep timing (low risk, n=50) and late sleep timing (high risk, n=100). All participants will complete the observational study: 2 weeks of home sleep monitoring (actigraphy), followed by an overnight laboratory visit to assess self-report, behavioral, and neuroimaging (fMRI) tasks tapping cognitive control and reward function, as well as circadian phase via salivary melatonin and molecular rhythms via hair follicles. The Late group will continue to the experimental study, each participant randomized to manipulation or attentional control conditions (n=50 each). Investigators will probe whether advancing sleep/circadian timing and extending sleep duration via sleep scheduling and chronotherapeutic approaches (reducing PM light exposure; administering AM bright light) improves sleep, circadian, and neurobehavioral function relevant to SUD risk. Finally, repeated 6-month follow-up assessments of sleep and SU for all participants are included to examine longitudinal associations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delayed Sleep Phase Syndrome
Keywords
adolescence, sleep, substance use, reward sensitivity and motivation, circadian phase and alignment, inhibition

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Advance/Extend Manipulation
Arm Type
Experimental
Arm Description
For ~2 weeks, Advance/Extend participants will advance bedtime and regularize wake time. The first night of the manipulation will be conducted in the lab under tightly-controlled experimental conditions. Participants will then go home and for the next 12 days will be instructed to: Sleep scheduling-- advance bedtime by 1.5 hours ( + sleep duration) Decrease evening blue light exposure via blue blocker goggles (2 hrs before bed) Increase morning bright light exposure via bright light goggles (30 min after rise) Monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraph
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Control participants will complete the baseline laboratory study, then maintain their habitual sleep schedules over the next 13 days at home, with no instruction on sleep timing or light exposure. Control participants will complete smartphone-and text-based assessments, thereby controlling for effort.
Intervention Type
Other
Intervention Name(s)
Increase morning bright light
Intervention Description
Participants will wear Re-Timer bright glasses for 30 minutes each morning upon rising
Intervention Type
Other
Intervention Name(s)
Decrease evening blue light
Intervention Description
Participants will wear blue light blocker goggles for 2 hours before bed
Intervention Type
Behavioral
Intervention Name(s)
Sleep Scheduling
Intervention Description
Participants will advance their bedtime by 1.5 hours and regularize their wake time
Intervention Type
Behavioral
Intervention Name(s)
Monitor sleep, mood, and substance use
Intervention Description
Participants will complete smartphone-based sleep, mood, and substance use monitoring
Primary Outcome Measure Information:
Title
Change from baseline in sleep duration at 2 weeks
Description
Assessed by 14-day wrist actigraphy
Time Frame
Baseline vs. 2 weeks
Title
Change from baseline in Sleep timing at 2 weeks
Description
Assessed by 14-day wrist actrigraphy
Time Frame
Baseline vs. 2 weeks
Title
Change from baseline in Circadian alignment at 2 weeks
Description
This is measured as the interval between dim light melatonin onset and midsleep.
Time Frame
Baseline vs. 2 weeks
Title
Change from baseline in behavioral reward motivation at 2 weeks
Description
Assessed by adjusted average pumps on Balloon Analogue Risk Task, a computerized measure of risk taking behavior in which participants are presented with a series of balloons and offered the chance to earn money by pumping each balloon up by clicking a button.
Time Frame
Baseline vs. 2 weeks
Title
Change from baseline in behavioral inhibition at 2 weeks
Description
Assessed by accuracy on Cued Go/No-Go Task, specifically correct response (withholding response) on go trials with no/go target
Time Frame
Baseline vs. 2 weeks
Title
Change from baseline in neural correlates of impulse control at 2 weeks
Description
This outcome will be measured during the Stop Signal Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the Executive Control Network, specifically, activation is defined as bold signal in regions of the Executive Control Network (particularly the inferior frontal gyrus) on correct Stop trials versus correct Go trials.
Time Frame
Baseline vs. 2 weeks
Title
Change from baseline in neural correlates of reward anticipation at 2 weeks
Description
This outcome will be measured during the Money Incentive Delay Task, which is a computerized an fMRI behavioral task. It will be assessed by activation within the reward network, specifically, activation is defined as bold signals in regions of the reward network (particularly the ventral striatum) on reward anticipation trials versus no money trials.
Time Frame
Baseline vs. 2 weeks
Secondary Outcome Measure Information:
Title
Caffeine use
Description
Assessed by self-report
Time Frame
Continuously up to every 6 months for up to 5 years
Title
Substance use
Description
Substance use on Time Line Follow Back interview. Specifically, the frequency (# of days) of substance use (yes/no) in the past 6 months.
Time Frame
Continuously up to every 6 months for up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Typically enrolled in a traditional high-school with synchronous learning (in-person or online synchronous learning, but not cyber- or home-schooling) [school closures during the COVID-19 pandemic are an exception to this] Physically and psychiatrically healthy Provision of written informed consent and assent Additional inclusion criterion for Experimental protocol: Meets operational definition of late sleep timing (>11:15PM habitual bedtime) Exclusion Criteria: History of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly use in the past year Significant or unstable acute or chronic medical conditions Frequent headaches or migraines History of seizures Current serious psychiatric disorder (e.g., depressive disorder, bipolar disorder, eating disorder, psychotic disorder diagnosis, alcohol use disorder or substance use disorder) that would interfere with completion of study procedures Family history of bipolar disorder among first degree relative Current syndromal sleep disorders other than insomnia and delayed sleep phase disorder MRI contraindications (ie, absence of metal in the body, pregnancy, claustrophobia) Pregnancy Medications that increase sensitivity to blue light/photosensitizing medications, including psychiatric neuroleptic drugs, psoralen drugs, antiarrhythmic drugs, etc. Changes to psychotropic medication regimen in the 2 weeks prior to enrollment, and/or major changes to medications during the study protocol If participants have an average bedtime that is later than 3:00AM or an average wake time later than 11:00AM they cannot participate in the study Participants should be EXCLUDED for other sleep disorders that require ongoing treatment Participants should be EXCLUDED for other sleep disorders that cause significant distress or impairment, per DSM 5 criteria in the Sleep SCID.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronette G Blake, MS
Phone
(412) 246-6443
Email
blakerg2@upmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brant Hasler, PhD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Western Psychiatric Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronette G Blake, MS
Phone
412-246-6443
Email
blakerg2@upmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Current and future investigators, both internal and external, may have access to de-identified data; however only group data would be shared.

Learn more about this trial

Experimental Manipulation of Sleep and Circadian Rhythms and the Role Played on Reward Function in Teens

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