Longitudinal Reciprocal Relationships Between Cannabis Use, Sleep, and the HPA-axis (CaSS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Daily Cannabis Use Frequency
研究概览
简要总结
The purpose of this study is to learn more about cannabis use, sleep, and stress, and whether there is any relationship between the three.
详细描述
After passing a physical assessment and psychological screen, 60 participants will be enrolled. Ahead of the 21-day protocol participants will report to our laboratory sleep facilities and will be set-up to perform a full polysomnography test (monitored overnight sleep with equipment including superficial electrodes, heart rate [HR] monitor, breathing monitors). This initial night of sleep with study equipment is provided in order to reduce sleep differences based on sleeping in a new environment and the burden of wearing equipment while sleeping. Before and after this 8h sleep period participants will be introduced to all surveys and behavioral testing that will be used as part of the experimental nights. Participants who complete the familiarization night will be randomized to two different possible experimental protocols that differ in the length of the sleep period. In order to fully characterize cannabis use behaviors (frequency, amount, mode of use) on sleep in an individual's typical environment (i.e. in the places and during the activities of normal living), we will implement 21 days of activity monitoring via multiple daily surveys (which collectively is a research strategy known as Ecological Monitoring Assessment [i.e., EMA]) along with concurrent actigraphy, that is, the monitoring of movement via the use of a wrist-worn watch-like device. Approximately one-week into this observational period, participants will complete the 2 x 4-night experimental nights (consecutive nights) with a washout (return to habitual sleep patterns) of at least 6 days.
Participants are able to spend the day outside of the laboratory during the experimental night period (i.e. they will come into the lab each night to sleep, and have their sleep monitored, but able to do normal activities during the days). Following in laboratory assessments, participants will complete any remaining at home assessments needed for 21 days of EMA/actigraphy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fluent in English
- •18.5<BMI<40 kg/m2
- •no shift work in the last 12 months
- •no travel across time zones in the last 2 months.
排除标准
- •Chronic disease-Medical history/prior diagnosis of the following:
- •cardiometabolic disease (e.g., myocardial infarction, angina, diabetes)
- •essential hypertension
- •hepatic impairment
- •severe obstructive sleep apnea
- •restless legs syndrome
- •parasomnia
- •neurological disease (e.g., early onset dementia)
- •unstable psychiatric disorders (e.g., bipolar disorder, schizophrenia, major depression with suicidality).
- •Drug/Alcohol use criteria:
- •Illicit drugs apart from cannabis or related products are prohibitive.
- •Volunteers may consume caffeine, however, >3 cups of coffee (or otherwise equivalent of >300mg/day) is prohibitive.
- •Participants who consume >14 alcoholic drinks/week and/or have a diagnosis (or history) of alcohol use disorder will be excluded (a toxicological urine screen will be conducted to verify reported non-use during the initial screening and on the day of admission to the in-laboratory portion of the study).
- •Use of prescription or over-the-counter medications or supplements that affect sleep are also exclusionary.
- •Contraceptives are required for women and will continue to be taken throughout the experiment.
- •Prior Shift Work:
- •Volunteers must have no history of working irregular day and night hours, regular night work, or rotating shift work for the 3 months prior to the study.
结局指标
主要结局
Daily Cannabis Use Frequency
时间窗: Assessed in surveys performed 4 times per day, and across the entire 21-day study
The number of smoking/vaping sessions per day.
Wake After Sleep Onset (WASO)
时间窗: 21 days
Wake after sleep onset (measured in minutes) will be assessed each night from actigraphy; larger value indicates greater disruptions to sleep.
Cortisol Awakening Response
时间窗: 8 nights
Salivary cortisol levels assessed as the difference between waking and peak levels assessed \~30-45 minutes after awakening.
次要结局
- Wake After Sleep Onset (Polysomnography)(8 nights)
- Sleep Latency(8 nights)
- Total Sleep Time(up to 21 days)
- Sleep Macroarchitecture(8 nights)
- Sleep Microarchitecture(8 nights)
- Median Reaction Time(8 days)
- Time to NREM1 Sleep (modified Maintenance of Wakefulness)(8 days)
- Subjective Sleepiness(21 days)
- Pre-Ejection Period(8 days)
- Sleep High Frequency Heart Rate Variability (HRV)(8 nights)
- Mood(21 days)
- Cannabis Use Composite Score(21 days)
- Positive Affect(21 days)
- Negative Affect(21 days)
- Sleep Low Frequency HRV(8 nights)
- Sleep Normalized HF Power(8 nights)
- Sleep standard deviation of the R-R interval of normal sinus beats (SDNN)(8 nights)
- Area under the curve of the CAR(8 nights)
研究者
Nicole Bowles
Assitant Professor
Oregon Health and Science University