[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nathaniel Jenkins\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100550996","the-iowa-aces-and-sleep-cohort-and-manipulating-sleep-in-young-adults-with-aces-studies-100550996",false,"NCT06454344","The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies","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","AIM 1\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. 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)\n17. 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)\n18. 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\n19. 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\n20. Unstable housing\n\nAIM 2\n\nInclusion Criteria:\n\n1. 18-29 years of age\n2. SBP \\\u003C129 and DBP \\\u003C90 mmHg\n3. Body Mass Index \\> 18.5 kg\u002Fm2 and \\\u003C35 kg\u002Fm2\n4. Willing to complete in-home sleep studies\n5. \\>= 3 Adverse Childhood Experiences\n6. PSQI Global Score \\>5\n7. Sleep Efficiency Score \\\u003C90%\n\nExclusion Criteria:\n\n1. Currently undergoing treatment for a sleep disorder or diagnosed with restless leg syndrome, hypersomnia, parasomnia or narcolepsy, or obstructive sleep apnea\n2. Currently performing overnight shift work\n3. Lifetime history of any psychiatric disorder with psychotic features or bipolar disorder, currently undergoing treatment for substance-induced mood disorder\n4. Endorsed suicidal ideation as indicated by a Moderate or High risk determination on the Columbia Suicide Risk Protocol\n5. Diagnosed neurological disorder or illness affecting the central nervous system\n6. Diagnosed acute or chronic autoimmune disease or chronic inflammatory condition\n7. Current or previous cancer diagnosis\n8. History of moderate or severe traumatic brain injury\n9. Current or previous history of CBT-I treatment or sleep restriction or cognitive restructuring therapy for sleep\n10. History of cardiometabolic disease (e.g., ischemic heart disease, coronary artery disease, stroke, chronic kidney disease, diabetes mellitus), pulmonary disease, or renal disease\n11. Current or recent (within past month) use of anti-hypertensive (including clonidine), lipid lowering, glucose- controlling, or prescription anti-inflammatory medications\n12. Current or recent (within past month) opiates, benzodiazepine or benzodiazepine receptor agonists, or trazodone\n13. Recent changes to or unstable treatment (changes within last 6 mo.) with prescription medications\n14. Currently smoking or using nicotine\n15. Current use of hormone therapy\n16. 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)\n17. 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)\n18. 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\n19. 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\n20. Unstable housing\n21. Likely Obstructive Sleep Apnea, as indicated by an apnea-hypopnea index (AHI) \\>= 15 events\u002Fhour or persistent hypoxemia, as indicated by an arterial oxygen saturation \\\u003C= 88% for \\>5 minutes per night.",true,"ALL","18 Years","29 Years",{"count":21,"type":22},70,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nIn 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:\n\n1. 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,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells. This study to achieve this Aim.\n\nIn 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:\n\n1. 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,\n2. in vivo assessment of endothelial function via flow-mediated dilation testing, and\n3. in vitro determination of endothelial cell inflammation and oxidative stress from biopsied endothelial cells.",[28,29,30,31,32,33,34,35,36],"Adverse Childhood Experiences","Vascular Dilatation","Sleep","Sleep Disturbance","Psychosocial Stressor","Psychological Trauma","Endothelial Dysfunction","Inflammation","Oxidative Stress","RECRUITING","2025-12-05",{"date":40,"type":41},"2025-12-11","ACTUAL",{"date":43,"type":41},"2024-05-01",{"date":45,"type":22},"2028-10-31",{"name":47,"class":48},"Nathaniel Jenkins","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":49},"100598581","aces-sirt1-and-premature-vascular-aging-in-humans-100598581","NCT07073352","ACEs, SIRT1, and Premature Vascular Aging in Humans","Adverse Childhood Experiences and Premature Vascular Aging in Humans: The Role of SIRT1","Inclusion Criteria:\n\n* 18 - 30 years\n* ACE score of 0 OR ≥4 (Aim 1); ACE score ≥4 (Aim 2)\n\nExclusion Criteria:\n\n* Resting arterial blood pressure \\>140\u002F90 mmHg\n* BMI ≥30 kg\u002Fm2 and\u002For weight unstable (\\>2.27 kg change) last 6 month\n* Cardiovascular, metabolic, or pulmonary disease\n* Cardiovascular or metabolic prescription drug use\n* Vasoactive antidepressant drug use (SSRIs and clonidine)\n* Currently pregnant or breastfeeding\n* Heavy alcohol consumption (AUDIT screening)\n* Use of illicit drugs\n* Current tobacco use\n* Regular vigorous (\\>6 MET s) aerobic exercise (\\>4 bouts\u002Fweek, \\>30 min\u002Fbout)\n* Dietary supplementation with antioxidants or habitual use of NSAIDs","30 Years",{"count":59,"type":22},30,[25],"Adverse childhood experiences (ACEs) are directly related to cardiovascular morbidity and mortality, and impaired vascular endothelial function (VEF) is an independent predictor of future cardiovascular disease (CVD) risk \\[1, 2\\]. Previous work from our lab (IRB 202010095) and others \\[3\\] demonstrates impaired VEF in young adults with prior exposure to ACEs even in the absence of clinical CVD risk factors. Sirtuin 1 (SIRT1) is a class III histone deacetylase (HDAC) that plays a role in regulating vascular homeostasis and reductions in SIRT1 are associated with age-related endothelial dysfunction \\[4\\]. We have shown that ACEs-related impairments in VEF are accompanied by reductions in SIRT1 \\[5\\]. However, the mechanisms by which ACE exposure promotes VEF remain unknown. The goal of this project is to establish proof of concept that alterations in vascular SIRT1 expression and activity mediate premature vascular aging in individuals with \\>=4 ACEs compared to those with 0 ACEs and that, because NAD+ is an essential substrate for SIRT1, increasing NAD+ bioavailability will restore VEF in those with \\>=4 ACEs.\n\nThus, we will use a robust translational approach coupling in vivo and in vitro measures of endothelial function, inflammation, oxidative stress, and SIRT1 expression and activity in young adults with (n=30-35) versus without (n=30-35) ACE exposure in a cross-sectional study, and during a randomized controlled trial employing a novel 4-week nicotinamide riboside (NR) supplementation approach to increase SIRT1 activity by increasing cellular NAD+ in ACE+ (n=15\u002Fgroup) to accomplish the following specific aims:\n\n1. Determine the mechanisms by which ACE exposure alters the regulation of VEF by SIRT1. We hypothesize that compared to those without ACEs (ACE-), ACE+ will have (H1a) elevated endothelial oxidative stress and inflammation, (H1b) accompanied by reduced endothelial SIRT1 expression and increased p66SHC expression and acetylation of p65 and p53, (H1c) in association with lower VEF.\n2. Determine how targeting SIRT1 by increasing NAD+ bioavailability affects VEF in young adults with ACEs. We hypothesize that systemic NR supplementation will (H2a) augment cellular SIRT1 activity and (H2b) improve VEF in ACE+.\n\n\\[1\\] Felitti, V.J., Anda, R.F., Nordenberg, D., Williamson, D.F., Spitz, A.M., Edwards, V., Koss, M.P., \\& Marks, J.S. (1998). Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults: The adverse childhood experiences (ace) study. American Journal of Preventive Medicine, 14(4), 245-258. https:\u002F\u002Fdoi.org\u002F10.1016\u002FS0749-3797(98)00017-8. \\[2\\] Jenkins, N.D.M., \\& Robinson, A.T. (2022). How do adverse childhood experiences get under the skin to promote cardiovascular disease? A focus on vascular health. Function (Oxf), 3(4), zqac032. PMC9279110. 10.1093\u002Ffunction\u002Fzqac032. \\[3\\] Rodriguez-Miguelez, P., Looney, J., Blackburn, M., Thomas, J., Pollock, J.S., \\& Harris, R.A. (2022). The link between childhood adversity and cardiovascular disease risk: Role of cerebral and systemic vasculature. Function. 10.1093\u002Ffunction\u002Fzqac029. \\[4\\] Thompson, A. M., Wagner, R., \\& Rzucidlo, E. M. (2014). Age-related loss of SirT1 expression results in dysregulated human vascular smooth muscle cell function. American Journal of Physiology-Heart and Circulatory Physiology, 307(4), H533-H541. \\[5\\] Jenkins, N.D.M., Rogers, E.M., Banks, N.F., Tomko, P.M., Sciarrillo, C.M., Emerson, S.R., Taylor, A., \\& Teague, T.K. (2021). Childhood psychosocial stress is linked with impaired vascular endothelial function, lower sirt1, and oxidative stress in young adulthood. Am J Physiol Heart Circ Physiol, 321(3), H532-H541. PMC8461842. 10.1152\u002Fajpheart.00123.2021",[28,34],"2025-07-09",{"date":65,"type":41},"2025-07-18",{"date":67,"type":41},"2025-03-27",{"date":69,"type":22},"2027-06-30",{"name":47,"class":48},""]