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

Launched by NATHANIEL JENKINS · Jun 9, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring how poor sleep quality is related to the effects of difficult childhood experiences and how this might affect blood vessel function in young adults. Researchers want to understand if sleep problems lead to issues like inflammation and stress on blood vessels, which can contribute to health problems later in life. The study involves two main parts: first, they will measure sleep patterns and blood vessel function in young adults aged 18 to 29 who have experienced childhood adversity. Then, some participants will take part in a 6-week program to improve their sleep, while others will wait and receive no treatment for now.

To be eligible, participants must be between 18 and 29 years old, have a healthy blood pressure and body weight, and be willing to complete sleep studies at home. They should also have experienced at least three adverse childhood events, such as abuse or neglect, and have some sleep difficulties. Participants will wear a device to track their sleep for a week and undergo tests to check their blood vessel health. This study aims to find out more about the connections between childhood experiences, sleep, and heart health, which could help improve treatment for those affected.

Gender

ALL

Eligibility criteria

• • 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.