Adverse Childhood ExperiencesNCT06454344
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-i) in people with Adverse Childhood Experiences and Vascular Dilatation, run by University of Wisconsin, Madison at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences, Vascular Dilatation, Sleep
- What is being tested?
- Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 May 2024to 31 Oct 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-29 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
- 18-29 years of age
- SBP <129 and DBP <90 mmHg
Show all 11Show fewer
- Body Mass Index > 18.5 kg/m2 and <35 kg/m2
- Willing to complete in-home sleep studies
- >= 3 Adverse Childhood Experiences
- PSQI Global Score >5
- Sleep Efficiency Score <90%
Who cannot join
- 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
Show all 42Show fewer
- 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
- 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)
- 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)
- 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
- 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
- Unstable housing
- AIM 2
- 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
- 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)
- 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)
- 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
- 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
- Unstable housing
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Integrative Laboratory of Applied Physiology and Lifestyle Medicine
Iowa City, Iowa, 52242
University of Wisconsin
Madison, Wisconsin, 53792
About this study
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
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:
Read more
- 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,
- in vivo assessment of endothelial function via flow-mediated dilation testing, and
- 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:
- 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,
- in vivo assessment of endothelial function via flow-mediated dilation testing, and
- in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.
- Conditions
- Adverse Childhood Experiences, Vascular Dilatation, Sleep, Sleep Disturbance, Psychosocial Stressor, Psychological Trauma
- Being tested
- Cognitive Behavioral Therapy for Insomnia (CBT-i)
- Medical subject headings
- Aneurysm, Parasomnias, Psychological Trauma, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy for Insomnia (CBT-i)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-i) | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i) |
| Waitlist Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Secondary outcomes (16)
Endothelial NFκB p65 expression.
Vascular endothelial cells will be biopsied and stained for inflammatory marker NFκB p65.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial TNF-α expression.
Vascular endothelial cells will be biopsied and stained for inflammatory marker TNF-α.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial MCP-1 expression.
Vascular endothelial cells will be biopsied and stained for inflammatory marker MCP-1.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial NADPH-oxidase p47phox expression.
Vascular endothelial cells will be biopsied and stained for NADPH-oxidase p47phox, a marker of oxidative stress.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial nitrotyrosine expression.
Vascular endothelial cells will be biopsied and stained for nitrotyrosine, a marker of oxidative stress.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating CRP
Blood samples will be collected and analyzed for inflammatory marker CRP in plasma.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating TNF-α
Blood samples will be collected and analyzed for inflammatory marker TNF-α in serum.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating MCP-1
Blood samples will be collected and analyzed for inflammatory marker MCP-1 in serum.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating IL1-RA
Blood samples will be collected and analyzed for inflammatory marker IL1-RA in plasma.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating oxidized low density lipoprotein
Blood samples will be collected and analyzed for oxidative stress marker oxidized low density lipoprotein in serum.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating 8-iso prostaglandin F2α
Blood samples will be collected and analyzed for oxidative stress marker 8-iso prostaglandin F2α in serum.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
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.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
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.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
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.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
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.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
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.
Measured: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start1 May 2024
- Primary completion30 May 2028 (estimated)
- Study completion31 Oct 2028 (estimated)
Why it 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).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nathaniel Jenkins, PhD, Principal investigator, Assistant Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454344
- Sponsor's protocol ID
- 2026-1020
- Other IDs
- 1R01HL167788-01A1, SOE | Kinesiology Operations, Protocol Version
- Status last verified
- Dec 2025
- First submitted
- 3 Jun 2024
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06454344
- Acronym / sponsor ID
- 2026-1020
- Conditions
- Adverse Childhood Experiences, Vascular Dilatation, Sleep, Sleep Disturbance, Psychosocial Stressor, Psychological Trauma
- Study type
- Interventional
- Recruitment status
- SuspendedReason 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).
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 31 Oct 2028 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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,
- in vivo assessment of endothelial function via flow-mediated dilation testing, and
- 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:
- 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,
- in vivo assessment of endothelial function via flow-mediated dilation testing, and
- in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy for Insomnia (CBT-i) | Experimental | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i) |
| Waitlist Control | No intervention | – |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 18-29 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
- 18-29 years of age
Key exclusion criteria (42 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive 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. | Behavioural | Cognitive Behavioral Therapy for Insomnia (CBT-i) |
Primary outcome
Vascular Endothelial Function
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
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.
16 secondary outcomes
Endothelial NFκB p65 expression.
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial TNF-α expression.
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial MCP-1 expression.
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial NADPH-oxidase p47phox expression.
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Endothelial nitrotyrosine expression.
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating CRP
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating TNF-α
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating MCP-1
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating IL1-RA
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating oxidized low density lipoprotein
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Circulating 8-iso prostaglandin F2α
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Anti-oxidant (Superoxide Dismutase) Activity in Peripheral Blood Mononuclear Cells
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Anti-oxidant (Glutathione Reductase) Activity in Peripheral Blood Mononuclear Cells
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Anti-oxidant (Catalase) Activity in Peripheral Blood Mononuclear Cells
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Perceived Stress
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Distress
Time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Yes
Related trials for Adverse Childhood Experiences
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
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Recruiting
A Pilot Study to Examine the Efficacy of Internet-Delivered Skills Training in Affective and Interpersonal Regulation (i-STAIR) for Individuals With Adverse Childhood Experiences and Subsyndromal Depression
Subthreshold Depression
Active, not recruiting
Resilient Students Training (ReST) : A Pilot RCT
Psychological Wellness
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A RCT Study
Psychological Distress, Adverse Childhood Experience
Not yet recruiting
EMI for Reducing Psychological Distress in Young Adults With Multiple ACEs: A Feasibility Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathaniel Jenkins, PhD principal investigator
Assistant Professor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy for Insomnia (CBT-i) in people with Adverse Childhood Experiences and Vascular Dilatation, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vascular Endothelial Function (time frame: Week 0 (Pre-Intervention) and Week 7 (Post-Intervention)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.