NCT06454344招募中不适用
Associations of Adverse Childhood Experiences, Sleep Disruption, and Vascular Dysfunction in Young Adults: The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Vascular Endothelial Function
研究概览
简要总结
The overall purpose of this study is to understand the role of disrupted sleep in the association of exposure to early life adversity (adverse childhood experiences (ACEs)) with vascular endothelial (dys)function.
In Aim 1 (The Iowa ACEs and Sleep Cohort Study), the investigators will utilize a cross-sectional cohort design with a state-of-the-art translational approach. Participants will be recruited to objectively characterize the degree to which lower sleep quality and quantity contribute to ACEs-related endothelial dysfunction, inflammation, and oxidative stress in young adults using:
- rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,
- in vivo assessment of endothelial function via flow-mediated dilation testing, and
- in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim.
In Aim 2, approximately 70 eligible participants from Aim 1 (The Iowa ACEs and Sleep Cohort Study) will then be randomized to either a 6-week behavioral sleep intervention (cognitive behavioral therapy for insomnia) or a wait-list control to determine the mechanistic contribution of sleep disruption to vascular dysfunction in young adults with moderate-to-high exposure to adverse childhood experiences (ACEs). Following the intervention, participants will again complete:
- rigorous at home sleep monitoring using 7-nights of wrist actigraphy and 2 nights of home-based polysomnography to objectively measure sleep quality (sleep efficiency, wakefulness after sleep onset and sleep depth), and total sleep duration,
- in vivo assessment of endothelial function via flow-mediated dilation testing, and
- in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18-29 years of age
- •SBP <129 and DBP <90 mmHg
- •Body Mass Index > 18.5 kg/m2 and <35 kg/m2
- •Willing to complete in-home sleep studies
排除标准
- •Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea
- •Currently performing overnight shift work
- •Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder
- •Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol
- •Diagnosed neurological disorder or illness affecting the central nervous system
- •Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition
- •Current or previous cancer diagnosis
- •History of moderate or severe traumatic brain injury
- •Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep
- •History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease
- •Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications
- •Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone
- •Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications
- •Currently smoking or using nicotine
- •Current use of hormone therapy
- •Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)
- •Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)
- •Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home
- •Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week
- •Unstable housing
- •Inclusion Criteria:
- •18-29 years of age
- •SBP <129 and DBP <90 mmHg
- •Body Mass Index > 18.5 kg/m2 and <35 kg/m2
- •Willing to complete in-home sleep studies
- •>= 3 Adverse Childhood Experiences
- •PSQI Global Score >5
- •Sleep Efficiency Score <90%
- •Exclusion Criteria:
- •Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea
- •Currently performing overnight shift work
- •Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder
- •Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol
- •Diagnosed neurological disorder or illness affecting the central nervous system
- •Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition
- •Current or previous cancer diagnosis
- •History of moderate or severe traumatic brain injury
- •Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep
- •History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease
- •Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications
- •Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone
- •Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications
- •Currently smoking or using nicotine
- •Current use of hormone therapy
- •Current heavy alcohol use, as defined as binge drinking on 5 or more days in the last month, or consuming more than 7 (women) or 14 (men) drinks per week in the last month (per NIAAA definition)
- •Current or recent (within the last 6 mo.) illicit drug use disorder as indicated by a score of 3 or greater on the Drug Abuse Screening Test (DAST-10)
- •Current or recent (within 6 mo.) pregnancy OR current or recent breastfeeding (within 3 mo.) OR children under the age of 2 years old in the home
- •Currently completing greater than 300 minutes of moderate intensity, or greater than 150 minutes of vigorous intensity physical activity, or an equal combination per week
- •Unstable housing
- •Likely Obstructive Sleep Apnea, as indicated by an apnea-hypopnea index (AHI) >= 15 events/hour or persistent hypoxemia, as indicated by an arterial oxygen saturation <= 88% for >5 minutes per night.
结局指标
主要结局
Vascular Endothelial Function
时间窗: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
The brachial artery flow-mediated dilation (FMD) technique, a non-invasive bioassay of endothelium-dependent vasodilatory function, will be used as the primary determinant of in-vivo vascular endothelial function.
次要结局
- Endothelial nitrotyrosine expression.(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Circulating IL1-RA(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Anti-oxidant (Superoxide Dismutase) Activity in Peripheral Blood Mononuclear Cells(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Anti-oxidant (Glutathione Reductase) Activity in Peripheral Blood Mononuclear Cells(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Endothelial NFκB p65 expression.(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Endothelial TNF-α expression.(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Endothelial MCP-1 expression.(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Circulating CRP(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Circulating oxidized low density lipoprotein(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Circulating 8-iso prostaglandin F2α(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Endothelial NADPH-oxidase p47phox expression.(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Anti-oxidant (Catalase) Activity in Peripheral Blood Mononuclear Cells(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Perceived Stress(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Distress(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Circulating TNF-α(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
- Circulating MCP-1(Week 0 (Pre-Intervention) and Week 7 (Post-Intervention))
研究者
Nathaniel Jenkins
Assistant Professor, Principal Investigator
University of Iowa
研究点 (2)
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