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Can fixing sleep heal blood vessels after childhood trauma?

NCT ID NCT06454344

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at how difficult childhood experiences and poor sleep might harm blood vessel function in young adults aged 18-29. Researchers will monitor sleep at home and test blood vessel health. Some participants will receive a 6-week sleep therapy program (CBT-i) to see if improving sleep can help blood vessels work better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Cognitive Behavioral Therapy for Insomnia (CBT-i)
What this could lead to
If it works, this could point toward a way to improve blood vessel health in young adults with a history of childhood trauma by treating their sleep problems.
What could go wrong
This is a small, early-stage study with only 70 participants. The sleep therapy may not improve blood vessel function, and results may not apply to everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2024

Expected to finish

Oct 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 29 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

AIM 1 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 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 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.

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Conditions

The condition(s) this trial relates to.

Aneurysm Inflammation inflammatory disease Parasomnias Psychological Trauma sleep disorder vascular ectasia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Integrative Laboratory of Applied Physiology and Lifestyle Medicine

    RECRUITING

    Iowa City, Iowa, 52242, United States

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Other studies related to the condition(s) this trial covers.