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SuspendedNCT06454344Updated Oct 29, 2026

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

An interventional study of Cognitive Behavioral Therapy for Insomnia (CBT-i) in Adverse Childhood Experiences, Vascular Dilatation and Sleep, sponsored by University of Wisconsin, Madison. Suspended at 2 sites in United States. Open to participants aged 18 Years to 29 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by University of Wisconsin, Madison · Not applicable, Interventional, and Basic science

Why this study was suspended
Enrollment temporarily paused while the PI and award transfer from the University of Iowa to the University of Wisconsin-Madison. Recruitment will resume after UW-Madison IRB approval and award activation (anticipated early 2027).
Updated Oct 29, 2026Now SuspendedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 29 Years
Sex
All
01

Study 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. 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.
02

Conditions studied

  • Adverse Childhood Experiences
  • Vascular Dilatation
  • Sleep
  • Sleep Disturbance
  • Psychosocial Stressor
  • Psychological Trauma
  • Endothelial Dysfunction
  • Inflammation
  • Oxidative Stress
03

In context

Aneurysm

381 studies on the registry are indexed under Aneurysm; 78 are open to participants now.

This study's planned enrollment of 70 is above the median of 46 across 235 interventional studies indexed under Aneurysm.

Browse Aneurysm studies →

Lead sponsor

University of Wisconsin, Madison is the lead sponsor of 1,188 studies on the registry; 181 are open to participants now.

Of its 157 completed or terminated interventional studies of FDA-regulated products, 118 (75%) have results posted.

Browse University of Wisconsin, Madison studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 29 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

AIM 1

Inclusion Criteria:

  1. 18-29 years of age
  2. SBP \<129 and DBP \<90 mmHg
  3. > 18.5 kg/m2 and \<35 kg/m2
  4. Willing to complete in-home sleep studies

Exclusion Criteria:

  1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea
  2. Currently performing overnight shift work
  3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder
  4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol
  5. Diagnosed neurological disorder or illness affecting the central nervous system
  6. Diagnosed acute or chronic disease or chronic inflammatory condition
  7. Current or previous cancer diagnosis
  8. History of moderate or severe traumatic brain injury
  9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep
  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. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications
  12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone
  13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications
  14. Currently smoking or using nicotine
  15. Current use of hormone therapy
  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. 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. 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. 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. Unstable housing

AIM 2

Inclusion Criteria:

  1. 18-29 years of age
  2. SBP \<129 and DBP \<90 mmHg
  3. Body Mass Index > 18.5 kg/m2 and \<35 kg/m2
  4. Willing to complete in-home sleep studies
  5. >= 3 Adverse Childhood Experiences
  6. PSQI Global Score >5
  7. Sleep Efficiency Score \<90%

Exclusion Criteria:

  1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea
  2. Currently performing overnight shift work
  3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder
  4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol
  5. Diagnosed neurological disorder or illness affecting the central nervous system
  6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition
  7. Current or previous cancer diagnosis
  8. History of moderate or severe traumatic brain injury
  9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep
  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. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications
  12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone
  13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications
  14. Currently smoking or using nicotine
  15. Current use of hormone therapy
  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. 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. 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. 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. Unstable housing
  21. Likely Obstructive Sleep Apnea, as indicated by an apnea-hypopnea index (AHI) >= 15 events/hour or persistent hypoxemia, as indicated by an arterial oxygen saturation \<= 88% for >5 minutes per night.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    Cognitive Behavioral Therapy for Insomnia (CBT-i)

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

  • No intervention
    Waitlist Control

Interventions

  • BehavioralCognitive Behavioral Therapy for Insomnia (CBT-i)

    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.

06

What researchers measure

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.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

Secondary outcomes

  1. Endothelial NFκB p65 expression.

    Vascular endothelial cells will be biopsied and stained for inflammatory marker NFκB p65.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  2. Endothelial TNF-α expression.

    Vascular endothelial cells will be biopsied and stained for inflammatory marker TNF-α.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  3. Endothelial MCP-1 expression.

    Vascular endothelial cells will be biopsied and stained for inflammatory marker MCP-1.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  4. Endothelial NADPH-oxidase p47phox expression.

    Vascular endothelial cells will be biopsied and stained for NADPH-oxidase p47phox, a marker of oxidative stress.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  5. Endothelial nitrotyrosine expression.

    Vascular endothelial cells will be biopsied and stained for nitrotyrosine, a marker of oxidative stress.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  6. Circulating CRP

    Blood samples will be collected and analyzed for inflammatory marker CRP in plasma.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  7. Circulating TNF-α

    Blood samples will be collected and analyzed for inflammatory marker TNF-α in serum.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  8. Circulating MCP-1

    Blood samples will be collected and analyzed for inflammatory marker MCP-1 in serum.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  9. Circulating IL1-RA

    Blood samples will be collected and analyzed for inflammatory marker IL1-RA in plasma.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  10. Circulating oxidized low density lipoprotein

    Blood samples will be collected and analyzed for oxidative stress marker oxidized low density lipoprotein in serum.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  11. Circulating 8-iso prostaglandin F2α

    Blood samples will be collected and analyzed for oxidative stress marker 8-iso prostaglandin F2α in serum.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  12. Anti-oxidant (Superoxide Dismutase) Activity in Peripheral Blood Mononuclear Cells

    Peripheral blood mononuclear cells will be isolated from whole blood pre and post intervention and superoxide dismutase activity will be quantified using calorimetric assay.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  13. Anti-oxidant (Glutathione Reductase) Activity in Peripheral Blood Mononuclear Cells

    Peripheral blood mononuclear cells will be isolated from whole blood pre and post intervention and glutathione reductase activity will be quantified using calorimetric assay.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  14. Anti-oxidant (Catalase) Activity in Peripheral Blood Mononuclear Cells

    Peripheral blood mononuclear cells will be isolated from whole blood pre and post intervention and catalase activity will be quantified using calorimetric assay.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  15. Perceived Stress

    The investigators will measure perceived stress using the "Perceived Stress Scale" (PSS-10). This will be considered one of the mediators alongside sleep in the investigators' models, as the addition of other potential mediators can improve power and provide a more accurate estimate of the original (sleep) mediator by controlling for shared effects among mediators. The PSS-10 has a minimum score of "0" and a maximum score of "40" with higher scores indicating worse outcomes.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  16. Distress

    The investigators will measure distress using the "Kessler Psychological Distress Scale" (K-10). This will be considered one of the mediators alongside sleep in the investigators' models, as the addition of other potential mediators can improve power and provide a more accurate estimate of the original (sleep) mediator by controlling for shared effects among mediators. The K-10 has a minimum score of "10" and a maximum score of "50" with higher scores indicating worse outcomes.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

Other outcomes

  1. Sleep Quality

    The investigators will objectively quantify sleep quality as actigraphy measured as sleep efficiency (PRIMARY independent variable) and wakefulness after sleep onset and PSG measured sleep depth as indicated by the relative time spent in slow wave sleep. The investigators will also assess sleep efficiency and wakefulness after sleep onset using sleep diaries. These parameters are considered the independent variable in this study, with the primary identified independent variable identified as sleep efficiency. Collection of these data will be used to a) confirm changes and b) examine whether changes in the variables do in fact mediate changes in vascular function.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  2. Sleep Duration

    The investigators will objectively quantify total sleep duration using actigraphy and via sleep diary.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  3. Anxiety and Depression

    Anxiety and depression symptoms will be assessed using the "Inventory of Depression and Anxiety Symptoms-II" (IDAS-II), which is a reliable, well-validated assessment of mood and anxiety disorder symptoms. Using this scale, anxiety and depression ill be well-measured, and the investigators will assess their role as confounders/mediators in analyses. Each scale is individually assessed, meaning that the minimum score for mood symptoms, specifically, ranges from 3-20, and the maximum score ranges from 15-100 for this scale. With regards to anxiety disorder symptoms, the minimum score ranges from 3-8, and the maximum score ranges from 15-40. Higher scores on scales indicate worse outcomes.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

  4. Trauma

    Trauma symptoms will be assessed using the "PTSD Checklist for DSM-5" (PCL-5) with Life Events checklist. Using this scale, trauma symptoms will be well-measured, and the investigators will assess their role as confounders/mediators in analyses. The minimum value for this scale is "0" and the maximum value for this scale is "80". Higher scores on this scale indicate a worse outcome.

    Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)

07

Study locations

2 sites
  • Integrative Laboratory of Applied Physiology and Lifestyle Medicine
    Iowa City, Iowa 52242, United States
  • University of Wisconsin
    Madison, Wisconsin 53792, United States
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started May 2024 (actual). Primary completion is estimated for May 2028, 48 months after the start.

Primary completion moved once since we started tracking on Sep 25, 2026: Dec 2027 → May 2028, on Oct 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 3, 2024
First posted
Jun 12, 2024
StartActual
May 1, 2024
Primary completionEst.
May 30, 2028was Dec 2027
CompletionEst.
Oct 31, 2028
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Suspended Enrollment temporarily paused while the PI and award transfer from the University of Iowa to the University of Wisconsin-Madison. Recruitment will resume after UW-Madison IRB approval and award activation (anticipated early 2027).
changed Oct 29, 2026
Sites
1 site added
Show site
  • University of Wisconsin · Madison, United States
Oct 29, 2026
Primary completion
Dec 15, 2027→May 30, 2028
Oct 29, 2026
Sponsor
Nathaniel Jenkins→University of Wisconsin, Madison
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Recruiting→Suspended
    Why stopped Enrollment temporarily paused while the PI and award transfer from the University of Iowa to the University of Wisconsin-Madison. Recruitment will resume after UW-Madison IRB approval and award activation (anticipated early 2027).
    1 site added
    Show site
    • University of Wisconsin · Madison, United States
    Primary completion Dec 15, 2027→May 30, 2028
    Sponsor Nathaniel Jenkins→University of Wisconsin, Madison
    + 3 other changes: identifiers, contact details and data sharing statement

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06454344
Lead sponsor
University of Wisconsin, Madison
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Jun 12, 2024
Start date
May 1, 2024
Primary completion
May 30, 2028 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Oct 29, 2026

Study contacts

Nathaniel Jenkins, PhD
principal investigator · Assistant Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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