Center for Adolescent Reward, Rhythms and Sleep Project 1
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Change in slope of waking EEG theta power
研究概览
简要总结
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, which may increase 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 1 (P1), specifically examines homeostatic and circadian characteristics as mechanisms linking habitual sleep patterns, reward and cognitive control (at subjective, behavioral, and circuit levels), and longitudinal substance use risk.
详细描述
P1 will study 96 adolescents ages 13-15, stratified by habitual sleep timing (early, intermediate, late), in a 60-h laboratory study. Participants will monitor sleep patterns at home for 2 weeks with actigraphy and sleep diary, and will also complete fMRI measures of reward and cognitive control. This will be followed by a 60-hour laboratory visit. The laboratory session includes two nights of polysomnography (PSG) sleep studies, separated by 36 h of an ultradian sleep/wake protocol-every 120-minutes, there will be an 80-minute period of waking, followed by a 40-minute sleep opportunity. Participants will be in dim light conditions and temporal isolation for the first 24 h of the ultradian sleep/wake protocol. Physiological circadian measures include salivary melatonin; core body temperature (CBT); and molecular rhythms from hair follicle cells (examined in Project 3). Physiological sleep homeostatic measures include waking EEG theta power, slow-wave sleep rebound following the 36-h ultradian sleep/wake protocol, and repeated sleep latency on the sleep opportunities. Behavioral tests (Reward Anti-Saccade task to index cognitive control with/without reward modulation; Psychomotor Vigilance Test) and self-reports of mood/sleepiness will be collected every 2 h. Longitudinal on-line surveys will assess substance use every 6 months for the life of the grant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 13-15 years
- •Currently enrolled in a traditional high-school (not cyber- or home-schooled) [school closures during the COVID-19 pandemic are an exception to this]
- •Physically and psychiatrically healthy
- •Provision of written informed consent and assent
排除标准
- •outside age range above
- •have a history of alcohol, cannabis, or illicit drug use in the past month, or greater than monthly use in the past year
- •have serious medical or neurological disorders, including history of seizures
- •have serious psychiatric disorders (e.g. bipolar disorder and schizophrenia)
- •taking antidepressants (SSRIs/SSNIs are OK) or medications known to impact sleep/wake function - some medications may be okay if willing and able to discontinue prior to and/or for laboratory procedures
- •have sleep disorders other than insomnia or Delayed Sleep Phase Disorder
- •have MRI contraindications (i.e., metal in the body; claustrophobia)
- •first degree relative with bipolar disorder
- •frequent headaches or migraines
- •inability to swallow pills/capsules.
- •pregnancy
- •participants with observed Obstructive Sleep Apnea via Apnealink, as indicated by an Apnea Hypopnea Index (AHI) of greater than 5
- •Less than 80 lbs. or a BMI of greater than 35
结局指标
主要结局
Change in slope of waking EEG theta power
时间窗: Every 2 hours during the 36-hour ultradian sleep/wake protocol
Assessed every 2 hours across the 36-hour ultradian sleep/wake protocol
Melatonin onset
时间窗: The first 24-hours of the ultradian sleep/wake protocol
Endogenous circadian phase estimate of the rise in evening melatonin levels from saliva samples collected over a 24-hour period (every 30 - 60 minutes) under dim light conditions.
Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol.
时间窗: The first night of sleep preceding the 36-hour ultradian sleep/wake protocol vs the night of sleep following the ultradian sleep/wake protocol
Change in the slope of EEG delta power (0.5 - 4 Hz) across NREM periods (frontal leads) on the night preceding vs. following the 36-h ultradian sleep/wake protocol (as measured by polysomnography). This procedure is no longer being collected as of January 2026.
次要结局
- Melatonin amplitude(Collected every 30-60 minutes across the first 24-hours of the ultradian sleep/wake protocol)
- Circadian pattern of Core Body Temperature (CBT)(Measured continuously across the 36-hour ultradian sleep/wake protocol.)
- Sleep latency(During the 40-minute sleep opportunities collected every two hours across the 36-hour ultradian sleep/wake protocol.)
- Influence of sleep and circadian measures on neural correlates of impulse control(Measures from the 36-hour ultradian sleep/wake protocol in relation to an fMRI scan measured 1 to 2 weeks earlier.)
- Influence of sleep and circadian measures on neural correlates of reward anticipation and reward outcome.(1 to 2 weeks before to immediately after the 36-hour ultradian sleep/wake protocol.)
- Performance on the Psychomotor Vigilance Task(1 to 2 weeks before to immediately after the 36-hour ultradian sleep/wake protocol.)
- Performance on the Reward Anti-Saccade task(Measures collected every two hours during the 36-hour ultradian sleep/wake protocol.)
- Substance use(Every 6 months for the duration of the study, up to 4.5 years)
研究者
Peter Franzen
Associate Professor of Psychiatry and Clinical and Translational Science
University of Pittsburgh