Understanding how sleep affects young adults with early life adversity

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

This study is testing how poor sleep affects young adults aged 18-29 who had tough childhoods and whether a therapy for insomnia can help improve their sleep and overall health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 18 Years to 29 Years
• Sex: All
• Sponsor: University of Iowa (Academic / other)
• Locations: 1 site (Iowa City, Iowa)
• Trial ID: NCT06454344 on ClinicalTrials.gov

What this trial studies

This study aims to explore the impact of disrupted sleep on young adults who have experienced adverse childhood experiences (ACEs) and its relationship with vascular health. Participants aged 18-29 will undergo a comprehensive assessment involving home-based sleep monitoring and tests to evaluate endothelial function and inflammation. The study will utilize cognitive behavioral therapy for insomnia (CBT-i) as an intervention to improve sleep quality. By examining these factors, the research seeks to uncover the biological mechanisms linking ACEs to health outcomes.

Who should consider this trial

Good fit: Ideal candidates for this study are young adults aged 18-29 who have experienced adverse childhood experiences and are willing to participate in home sleep studies.

Not a fit: Patients currently undergoing treatment for sleep disorders or with a history of severe psychiatric or neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved sleep interventions that enhance vascular health in young adults with a history of adverse childhood experiences.

How similar studies have performed: While there is ongoing research into the effects of sleep on health, this specific approach focusing on ACEs and vascular function in young adults is relatively novel.

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.

Where this trial is running

Iowa City, Iowa

• Integrative Laboratory of Applied Physiology and Lifestyle Medicine — Iowa City, Iowa, United States (Recruiting)

Study contacts

• Principal investigator: Nathaniel Jenkins, PhD — Assistant Professor
• Study coordinator: Nathaniel D Jenkins, PhD

Conditions Adverse Childhood Experiences; Vascular Dilatation; Sleep; Sleep Disturbance; Psychosocial Stressor; Psychological Trauma; Endothelial Dysfunction; Inflammation