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

NCT06454344 | Recruiting

• 2 other identifiers: 2023071391R01HL167788-01A1
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 2.in vivo assessment of endothelial function via flow-mediated dilation testing, and
3. 3.in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim.
4. 4.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,
5. 5.in vivo assessment of endothelial function via flow-mediated dilation testing, and
6. 6.in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Vascular Endothelial Function

  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.

  Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

Secondary Outcomes (16)

• 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)

• Endothelial NADPH-oxidase p47phox expression.

  Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

• Endothelial nitrotyrosine expression.

  Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

Other Outcomes (4)

• Sleep Quality

  Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

• Sleep Duration

  Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

• Anxiety and Depression

  Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

Study Arms (2)

Cognitive Behavioral Therapy for Insomnia (CBT-i)

EXPERIMENTAL

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)

Waitlist Control

NO INTERVENTION

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-i) BEHAVIORAL

CBT-I is a structured program with a robust empirical evidence supporting its efficacy for improving sleep quality and quantity. The cognitive component of CBT-I teaching individuals how to recognize and change the beliefs they hold about sleep that negatively impact sleep, such as negative thoughts and emotions. The behavioral component includes several strategies to help improve sleep, including: improved sleep hygiene, improving the sleep environment, relaxation training, stimulus control therapy (consistent wake/sleep times, using the bed only for sleep, etc), and sleep restriction. Sleep restriction consists of reducing the time spend in bed initially to increase sleep drive in subsequent nights. Once sleep has improved, the time in bed is gradually increased again.

Cognitive Behavioral Therapy for Insomnia (CBT-i)

Eligibility Criteria

• Age: 18 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nathaniel Jenkins: lead

Study Sites (1)

Integrative Laboratory of Applied Physiology and Lifestyle Medicine

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Aneurysm; Parasomnias; Psychological Trauma; Inflammation

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nathaniel Jenkins, PhD

  Assistant Professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathaniel D Jenkins, PhD

CONTACT

3194673091; nathaniel-jenkins@uiowa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 12, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): October 31, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

US (1)