RECRUITING

The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-05-03
Study Completion:2028-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06454344

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 29 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 18-29 years of age
  2. 2. SBP \<129 and DBP \<90 mmHg
  3. 3. Body Mass Index \> 18.5 kg/m2 and \<35 kg/m2
  4. 4. Willing to complete in-home sleep studies
  1. 1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea
  2. 2. Currently performing overnight shift work
  3. 3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder
  4. 4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol
  5. 5. Diagnosed neurological disorder or illness affecting the central nervous system
  6. 6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition
  7. 7. Current or previous cancer diagnosis
  8. 8. History of moderate or severe traumatic brain injury
  9. 9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep
  10. 10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease
  11. 11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications
  12. 12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone
  13. 13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications
  14. 14. Currently smoking or using nicotine
  15. 15. Current use of hormone therapy
  16. 16. 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)
  17. 17. 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)
  18. 18. 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
  19. 19. 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
  20. 20. Unstable housing

Contacts and Locations

Study Contact

Nathaniel D Jenkins, PhD
CONTACT
3194673091
nathaniel-jenkins@uiowa.edu

Principal Investigator

Nathaniel Jenkins, PhD
PRINCIPAL_INVESTIGATOR
Assistant Professor

Study Locations (Sites)

Integrative Laboratory of Applied Physiology and Lifestyle Medicine
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: Nathaniel Jenkins

  • Nathaniel Jenkins, PhD, PRINCIPAL_INVESTIGATOR, Assistant Professor

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-03
Study Completion Date2028-10-31

Study Record Updates

Study Start Date2024-05-03
Study Completion Date2028-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Adverse Childhood Experiences
  • Vascular Dilatation
  • Sleep
  • Sleep Disturbance
  • Psychosocial Stressor
  • Psychological Trauma
  • Endothelial Dysfunction
  • Inflammation
  • Oxidative Stress