Actively Recruiting

Phase Not Applicable
Age: 18Years - 29Years
All Genders
Healthy Volunteers
ID06454344

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

Led by Nathaniel Jenkins · Updated on 2025-12-11

70

Participants Needed

1

Research Sites

45 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying how poor sleep may affect blood vessel health in young adults who experienced adverse childhood experiences (ACEs). This study aims to understand how disrupted sleep contributes to inflammation, oxidative stress, and blood vessel dysfunction linked to early life stress. The project includes two parts: one observational cohort study and a randomized trial testing a sleep therapy. The study includes young adults aged 18 to 29 years. Initially, participants will have their sleep measured at home using wrist devices for 7 nights and 2 nights of detailed sleep monitoring to assess sleep quality and duration. Blood vessel function will be measured using flow-mediated dilation testing, and small samples of blood vessel cells will be analyzed for inflammation and oxidative stress. About 70 participants with moderate-to-high ACEs will then be randomly assigned to either a 6-week cognitive behavioral therapy for insomnia (CBT-I) or a waitlist control. Afterward, all participants will repeat the same sleep and blood vessel assessments. Participants will be involved for at least 7 weeks, including pre- and post-intervention assessments. They will complete sleep monitoring at home, blood vessel function testing, and blood vessel cell biopsies twice. Researchers will also measure stress levels and various markers related to inflammation and oxidative stress before and after the intervention. The study carefully monitors sleep patterns and vascular health to understand how improving sleep might influence blood vessel function in young adults with ACEs.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 29Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 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: At least 3 adverse childhood experiences
  • For Aim 2: Pittsburgh Sleep Quality Index global score greater than 5
  • For Aim 2: Sleep efficiency score less than 90%
Not Eligible

You will not qualify if you...

  • Currently being treated for sleep disorders such as restless leg syndrome, hypersomnia, parasomnia, narcolepsy, or obstructive sleep apnea
  • Performing overnight shift work
  • History of psychiatric disorders with psychotic features or bipolar disorder or current treatment for substance-induced mood disorder
  • Suicidal ideation with moderate or high risk
  • Diagnosed neurological disorder affecting the central nervous system
  • Acute or chronic autoimmune or inflammatory diseases
  • Current or past cancer diagnosis
  • History of moderate or severe traumatic brain injury
  • Current or previous cognitive behavioral therapy for insomnia or similar sleep therapy
  • History of cardiometabolic, pulmonary, or renal disease
  • Recent use of anti-hypertensive, lipid-lowering, glucose-controlling, or prescription anti-inflammatory medications
  • Recent use of opiates, benzodiazepines, or trazodone
  • Recent changes or unstable prescription medication treatment
  • Current smoking or nicotine use
  • Current use of hormone therapy
  • Heavy alcohol use as defined by binge drinking or weekly consumption limits
  • Recent illicit drug use disorder
  • Recent pregnancy, breastfeeding, or children under 2 years old in the home
  • Excessive physical activity levels
  • Unstable housing
  • For Aim 2: Likely obstructive sleep apnea indicated by specific sleep study results

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outpatient Treatment

Duration - 7 weeks

Participants receive Cognitive Behavioral Therapy for Insomnia (CBT-I), a structured program designed to improve sleep quality through behavioral and cognitive strategies.

Weekly visits for up to 7 weeks

Trial Site Locations

Total: 1 location

1

Integrative Laboratory of Applied Physiology and Lifestyle Medicine

Iowa City, Iowa, United States, 52242

Actively Recruiting

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Research Team

N

Nathaniel D Jenkins, PhD

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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