Stress, Sleep and Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- sleep efficiency
研究概览
简要总结
We are evaluating a model where trauma exposure and threatening environments elicit nocturnal vigilance and sleep-related fears that compromise the healthy reduction of autonomic arousal during sleep which in turn stimulates secretion of atherogenic humoral factors, arterial stiffening, and cardiovascular disease risk. We will examine the roles of pre-sleep cognition using a questionnaire and real time assessment, and modifiable strategies for coping with sleep disruptive cognitions. We will then evaluate the impact of providing personalized feedback and recommendations based on study observations on how participants cope with potentially sleep disruptive cognitions and sleep efficiency in a randomized trial.
详细描述
The study has 3 specific aims.
Aim 1. To confirm the effects of neighborhood and posttraumatic stress, and nocturnal vigilance on nocturnal autonomic balance determined by complementary biomarkers.
Hypothesis 1a - Neighborhood disorder and posttraumatic stress symptom severity will be inversely correlated with indicators of autonomic balance derived from analyses of heart rate variability and cardiac impedence, and nocturnal/evening urinary noradrenergic excretion ratios.
Hypothesis 1b - These relationships will be partially or fully accounted for by nocturnal vigilance and the frequency and intensity of pre-sleep disruptive cognitions assessed in real time, and strategies for coping with sleep disruptive thoughts.
Aim 2. To determine relationships of nocturnal autonomic activity to biomarkers of inflammation and endothelial dysfunction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adults age 18 - 35, self-identified as Black or African American, born in the United States.
排除标准
- •current medical or psychiatric condition that affects sleep or requires daily - use of medication other than PTSD, phobic disorders, or past history of major depression
- •severe alcohol or drug use disorders
- •overnight shift worker or an extreme chronotype
- •sleep disorder other than insomnia or nightmares
- •morbid obesity (body mass index > 40)
研究组 & 干预措施
personalized behavioral recommendations
Will receive recommendations for altering sleep related behavior based on data from in-home monitoring.
干预措施: Personalized sleep intervention (Behavioral)
educational control
Will receive the data without recommendations. Will receive personalized recommendations after the follow up assessment.
结局指标
主要结局
sleep efficiency
时间窗: 6 months
percent of time in bed spent asleep
次要结局
- pulse wave velocity(6 months)
- normalized high frequency ratio of heart rate variability while in bed(6 months)