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CompletadoNCT07927335Registro de ClinicalTrials.gov

ACEs, CBT-i, and Cardiovascular Health

Adverse Childhood Experiences · Sleep Disruption · Vascular Dysfunction · Endothelial Function (FMD)

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - 29 años
Sexo admitido
Todos los sexos
Voluntarios sanos
Aceptados
Participantes
16 Real

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

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.

Leer la descripción completa

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

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

  • Age 18-29 years, inclusive

-≥4 adverse childhood experiences on the \[CDC-Kaiser 10-item\] ACE questionnaire AND self-reported childhood stress ≥4 on a 0-5 rating scale
* Poor sleep, defined as a PSQI global score \>5 AND PSQI-derived habitual sleep efficiency \<90%
* BMI ≤35 kg/m²
* Either has not been diagnosed with or has been on stable treatment for \>= 6 months for major depressive disorder or major anxiety disorders
* Willing and able to complete the intervention and all study procedures

Exclusion Criteria:

  • Diagnosed cardiometabolic disease, including cardiovascular disease, hypertension, type 1 or type 2 diabetes, or chronic kidney disease
  • Diagnosed sleep disorder (e.g., obstructive sleep apnea, insomnia disorder, narcolepsy, restless legs syndrome)
  • Current shift work involving overnight hours
  • Children living in the household
  • Current use of tobacco or nicotine products, including e-cigarettes and vaping
  • Daily alcohol consumption
  • Habitual caffeine intake \>5 mg/kg/day
Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
No aplica
Enmascaramiento
Sin enmascaramiento
CBT-I

Participants will undergo a CBT-i intervention delivered by clinical psychologists using telehealth inside of the UIowa Zoom ecosystem.

Behavioral: Cognitive Behavioral Therapy for Insomnia

Cognitive Behavioral Therapy for Insomnia BEHAVIORAL

The CBT-i intervention will be delivered by clinical psychologists (overseen by an experienced PhD-level Clinical Psychologist) who have completed CBT-i training at the University of Iowa. CBT-i is modular, manualized (see example in miscellaneous attachments), and thus highly standardized. CBT-i is the recommended first line treatment for those with insomnia (improving sleep in 75% of these) and has also shown efficacy for improving sleep in those with sub-clinical insomnia and with stress disorders (e.g., PTSD). CBT-i will be delivered in 6, \~1 hour sessions across the course of 6-7 weeks and the topics covered in each session (in order) will be: 1) Sleep Basics, 2) Sleep Schedules, 3) Sleep Hygiene, 4) Stress Management:Relaxation, 5) Stress Management: Stop Worrying About Sleep, 6) Stress Management: Problem Solving.

The intervention sessions will be delivered using telehealth inside of the UIowa Zoom ecosystem using private links.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Flow mediated dilation

Plazo: Prior to and at the end of 6 week CBT-I intervention

Brachial artery flow mediated dilation will be measured as a non-invasive indicator of endothelial function.

Medidas secundarias

Heart Rate Variabiliy

Plazo: Prior to and at the end of 6 week CBT-I intervention

Heart rate signals will be recorded using 3-lead ECG for 10 minutes while the participant rests quietly for measurement of heart rate and heart rate variability

Beat to beat blood pressure variability

Plazo: Prior to and at the end of 6 week CBT-I intervention

Beat-to-beat blood pressure signals will be recorded using finger photoplethysmography for 10 minutes while the participant rests quietly for measurement of blood pressure and blood pressure variability

Homeostatic Model Assessment of Insulin Resistance

Plazo: Prior to and at the end of 6 week CBT-I intervention

A fasting blood sample will be drawn to calculate HOMA-IR as (fasting glucose \[mg/dL\] x fasting insulin \[uIU/mL\] / 405)

Otras medidas

Waist Circumference

Plazo: Prior to and at the end of 6 week CBT-I intervention

Participants will have their waist circumference measured using a flexible Gulick tape.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

Integrative Laboratory of Applied Physiology and Lifestyle MedicineIowa City, Iowa, United StatesEstado desconocido

Equipo y fechas

Patrocinador principal
University of Iowa
Inicio del estudio
12 ene 2023 Real
Finalización primaria
8 may 2023 Real
Finalización del estudio
14 ene 2025 Real
Primera publicación
10 nov 2026 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

No hay un contacto central indicado. Revisa los centros y el registro oficial.

Título oficial del estudio

Cognitive Behavioral Therapy for Insomnia to Improve Sleep Quality, Stress, and Vascular and Metabolic Health in Young Adults With Early Life Adversity and Poor Sleep: A Pilot Study.

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026