The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies (NCT06454344)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Integrative Laboratory of Applied Physiology and Lifestyle Medicine โ Iowa City, Iowa
Age range: 18 Years to 29 Years
๐งช Interventions in This Study
- Cognitive Behavioral Therapy for Insomnia (CBT-i) (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (1 Sites)
- Integrative Laboratory of Applied Physiology and Lifestyle Medicine โ Iowa City, Iowa
๐ Contact the Study Coordinator
Phone: (319) 467-3091
Email: nathaniel-jenkins@uiowa.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Adverse Childhood Experiences
- Playing Playfully to Overcome Adversity โ Fairfield, Connecticut
- The THRIVE Study: Teaching Healthy Regulation in Individuals & Vulnerable Environments โ Irvine, California
- Childhood Trauma, Exercise, and Cognition โ Austin, Texas
- ACEs, SIRT1, and Premature Vascular Aging in Humans โ Iowa City, Iowa
- Building Resilient Families โ Loma Linda, California
- Neurobehavioral Mechanisms Linking Childhood Adversity to Increased Risk for Smoking โ Durham, North Carolina
Explore by condition: All Adverse Childhood Experiences clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.