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ClinicalTrials.gov·

ACEs, CBT-i, and Cardiovascular Health - NCT07927335

Sponsor: University of Iowa Conditions: Adverse Childhood Experiences, Sleep Disruption, Vascular Dysfunction, Endothelial Function (FMD) Our accumulating evidence indicates that young adults that have been exposed to Adverse Childhood Experiences (ACEs) display both impaired vascular function, poorer cardiometabolic health, and poor sleep. Our data indicate that sleep impairments may mediate the link between ACEs and vascular and metabolic dysfunction. The primary purpose of this project is to determine if cognitive behavioral therapy for insomnia (CBT-i) is feasible for improving sleep in young adults who have been exposed to ACEs and who have poor sleep. Secondarily, we will collect preliminary efficacy data to determine whether CBT-i can improve vascular and cardiometabolic health in this population, as well as perceived stress and anxiety. Sleep disruption is an important, emerging risk factor for CMD morbidity and mortality \[9\], and is associated with leading cardiometabolic risk factors such as hypertension, insulin resistance, and obesity \[1,2\]. It is likely that poor sleep increases CMD-related risk by promoting circadian disruption \[3\]. A growing body of evidence suggests that ACEs are associated with disturbed sleep. Indeed, strong preliminary evidence from our laboratory indicates that young adults with a history of ACEs self-report poor sleep and present with altered diurnal cortisol concentrations indicative of disrupted circadian variation \[4\]. Accordingly, our hypothesis is that sleep disruption is a hallmark, stress-related symptom of ACEs, and therefore that sleep disruption is a modifiable, mechanistic pathway by which ACEs promote CMD risk. Accordingly, building on our initial data indicating that poor sleep mediates the association between ACE exposure and vascular and metabolic dysfunction, our overall objective in this pilot project is to first (1) test the first line treatment to improve sleep among those suffering from insomnia (CBT-i) for improving sleep in individuals with high ACEs and sleep disruption and (2) explore whether this intervention promotes positive effects on vascular and metabolic health, as well as psychological coping, stress, and anxiety/depression symptoms. 1. St-Onge MP, Grandner MA, Brown D, et al. Sleep Duration and Quality: Impact on Lifestyle Behaviors and Cardiometabolic Health: A Scientific Statement From the American Heart Association. Circulation. 2016;134(18):e367-e86. 2. Cappuccio FP, Miller MA. Sleep and Cardio-Metabolic Disease. Curr Cardiol Rep. 2017;19(11):110. 3. Reutrakul S, Knutson KL. Consequences of Circadian Disruption on Cardiometabolic Health. Sleep Med Clin. 2015;10(4):455-68. 4. Jenkins NDM, Rogers EM, Banks NF, et al. Adverse childhood experiences are linked to disrupted sleep and diurnal cortisol concentrations in young adult women. Circulation. 2022;145:AMP46

Company
University of Iowa
Keywords
Adverse Childhood Experiences, Sleep Disruption, Vascular Dysfunction, Endothelial Function (FMD), adverse childhood experiences, sleep, vascular function, cardiovascular health, cognitive behavioral therapy for insomnia