Delayed Sleep Phase Syndrome Clinical Trial
— CARRS-P2Official title:
Center for Adolescent Reward, Rhythms and Sleep Project 2
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 30, 2025 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 13 Years to 15 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Western Psychiatric Hospital | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | National Institute on Drug Abuse (NIDA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in sleep duration at 2 weeks | Assessed by 14-day wrist actigraphy | Baseline vs. 2 weeks | |
Primary | Change from baseline in Sleep timing at 2 weeks | Assessed by 14-day wrist actrigraphy | Baseline vs. 2 weeks | |
Primary | Change from baseline in Circadian alignment at 2 weeks | This is measured as the interval between dim light melatonin onset and midsleep. | Baseline vs. 2 weeks | |
Primary | 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. | Baseline vs. 2 weeks | |
Primary | 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 | Baseline vs. 2 weeks | |
Primary | 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. | Baseline vs. 2 weeks | |
Primary | 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. | Baseline vs. 2 weeks | |
Secondary | Caffeine use | Assessed by self-report | Continuously up to every 6 months for up to 5 years | |
Secondary | 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. | Continuously up to every 6 months for up to 5 years |
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