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

Nathaniel Jenkins

Status: Enrolling

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

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)

Study type: Interventional

Funder types: Other

Identifiers

NCT06454344

1R01HL167788-01A1 (U.S. NIH Grant/Contract)

202307139

Details and patient eligibility

About

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:

1. 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,
2. in vivo assessment of endothelial function via flow-mediated dilation testing, and
3. 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:

1. 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,
2. in vivo assessment of endothelial function via flow-mediated dilation testing, and
3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.

Enrollment: 70 estimated patients

Sex: All

Ages: 18 to 29 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Cognitive Behavioral Therapy for Insomnia (CBT-i)

Experimental group

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-i)

Waitlist Control

No Intervention group