BridgeMD
New treatment option for Adverse Childhood Experiences
Official title The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
ClinicalTrials.gov ID: NCT06454344
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 29. Healthy volunteers may be eligible.
You may be able to join if
- AIM 1
- 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
You likely can't join if
- Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive...
- Currently performing overnight shift work
- Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood...
- 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
See the full eligibility criteria
Who can join
- AIM 1
- 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
What rules you out
- 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 AIM 2 Inclusion Criteria:
- 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
- \>= 3 Adverse Childhood Experiences
- PSQI Global Score \>5
- Sleep Efficiency Score \<90% Exclusion Criteria:
- 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 \ 5 minutes per night.
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 29 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.