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
- 200
- 试验地点
- 1
- 主要终点
- Change in EEG delta power across overnight polysomnography on the night preceding vs. following the 36-hour ultradian sleep/wake protocol.
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 200 adolescents ages 13-18 in a 48-h to 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 48-to-60-hour laboratory visit. The laboratory session includes two nights of polysomnography (PSG) sleep studies (the second night of PSG was halted for all participants as of January 2026), separated by 28 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. (Prior to January 2026, participants had a 36-h ultradian sleep/wake protocol, which was then shortened to 28 hours). Participants will be in dim light conditions and temporal isolation for the first 28 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 ultradian sleep/wake protocol (for participants enrolled prior to January 2026), 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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 13-18 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 greater than weekly 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
研究组 & 干预措施
Ultradian Sleep/Wake protocol
This study uses an ultradian sleep/wake protocol to examine circadian and homeostatic sleep systems and their contributions to reward and cognitive control function. All participants will undergo the ultradian sleep/wake protocol following a night of sleep in the lab (measured with polysomnography). The ultradian sleep/wake protocol will last for 28-36 h, during which every 120-minutes, there will be an 80-minute period of waking, followed by a 40-minute sleep opportunity. Prior to 2026, a repeat night of sleep will occur at the end of the 36-hour ultradian sleep/wake protocol. As of 2026, the repeat sleep study is no longer being conducted, and the ultradian protocol was shortened to 28 hours.
干预措施: Ultradian sleep/wake protocol (Behavioral)
结局指标
主要结局
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.
Change in slope of waking EEG theta power
时间窗: Every 2 hours during the ultradian sleep/wake protocol, up two 36 hours
Assessed every 2 hours across the ultradian sleep/wake protocol
Melatonin onset
时间窗: The first 28-hours of the ultradian sleep/wake protocol
Endogenous circadian phase estimate of the rise in evening melatonin levels from saliva samples collected over the ultradian protocol (every 30 - 60 minutes) under dim light conditions.
次要结局
- Substance use(Every 6 months for the duration of the study, up to 4.5 years)
- Circadian pattern of Core Body Temperature (CBT)(Measured continuously across the ultradian sleep/wake protocol, up two 36 hours.)
- Melatonin amplitude(Collected every 30-60 minutes across the ultradian sleep/wake protocol, up two 36 hours)
- Sleep latency(During the 40-minute sleep opportunities collected every two hours across the ultradian sleep/wake protocol, up two 36 hours)
- Influence of sleep and circadian measures on neural correlates of impulse control(Measures from the 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 ultradian sleep/wake protocol.)
- Performance on the Psychomotor Vigilance Task(Collected every 2 hours during the ultradian sleep/wake protocol, up two 36 hours.)
- Performance on the Reward Anti-Saccade task(Collected every two hours during the ultradian sleep/wake protocol, up two 36 hours.)
研究者
Peter Franzen
Associate Professor of Psychiatry and Clinical and Translational Science
University of Pittsburgh