Actively Recruiting
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
Led by Nathaniel Jenkins · Updated on 2025-12-11
70
Participants Needed
1
Research Sites
234 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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: 1. 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, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. 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: 1. 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, 2. in vivo assessment of endothelial function via flow-mediated dilation testing, and 3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.
CONDITIONS
Official Title
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 29 years
- Systolic blood pressure less than 129 mmHg and diastolic blood pressure less than 90 mmHg
- Body Mass Index between 18.5 and 35 kg/m2
- Willingness to complete in-home sleep studies
- For Aim 2 participants: at least 3 Adverse Childhood Experiences
- For Aim 2 participants: Pittsburgh Sleep Quality Index (PSQI) Global Score greater than 5
- For Aim 2 participants: Sleep efficiency score less than 90%
You will not qualify if you...
- Currently treated for or diagnosed with sleep disorders such as restless leg syndrome, hypersomnia, parasomnia, narcolepsy, or obstructive sleep apnea
- Currently working overnight shifts
- Lifetime history of psychiatric disorders with psychotic features or bipolar disorder, or current treatment for substance-induced mood disorder
- Moderate or high suicide risk as per Columbia Suicide Risk Protocol
- Diagnosed neurological disorders affecting the central nervous system
- Diagnosed acute or chronic autoimmune or inflammatory conditions
- Current or past cancer diagnosis
- History of moderate or severe traumatic brain injury
- Previous treatment with cognitive behavioral therapy for insomnia, sleep restriction, or cognitive restructuring therapy for sleep
- History of cardiometabolic, pulmonary, or renal diseases
- Current or recent use (within past month) of anti-hypertensive, lipid lowering, glucose-controlling, or prescription anti-inflammatory medications
- Current or recent use (within past month) of opiates, benzodiazepines, benzodiazepine receptor agonists, or trazodone
- Recent changes or unstable treatment with prescription medications within last 6 months
- Current smoking or nicotine use
- Current use of hormone therapy
- Heavy alcohol use defined as binge drinking on 5 or more days in the last month or exceeding weekly drink limits
- Current or recent illicit drug use disorder within last 6 months
- Current or recent pregnancy or breastfeeding, or having children under 2 years old in the home
- Engaging in more than 300 minutes of moderate or more than 150 minutes of vigorous physical activity per week
- Unstable housing
- For Aim 2 participants: likely obstructive sleep apnea indicated by apnea-hypopnea index of 15 or more events per hour or persistent low oxygen saturation at night
AI-Screening
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Trial Site Locations
Total: 1 location
1
Integrative Laboratory of Applied Physiology and Lifestyle Medicine
Iowa City, Iowa, United States, 52242
Actively Recruiting
Research Team
N
Nathaniel D Jenkins, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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