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NCT06454344 · ClinicalTrials.gov registry record · NA
The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies
A NA study of Sleep and Inflammation, sponsored by Nathaniel Jenkins.
- Recruiting
- Registry status
- NA
- Development phase
- 70
- Enrollment target
- 1
- Study location
NCT06454344 is a NA study of Sleep and Inflammation that is actively recruiting participants, run by Nathaniel Jenkins. The registered enrollment target is 70 participants, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06454344, a NA study of Sleep and Inflammation, is actively recruiting participants, sponsored by Nathaniel Jenkins.
- RECRUITING
- Registry status
- NA
- Development phase
- 70 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy for Insomnia (CBT-i)
Study Locations (1)
Iowa
- Integrative Laboratory of Applied Physiology and Lifestyle Medicine - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2028-10-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06454344
The ClinicalTrials.gov registry entry for NCT06454344 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (98% lower). The listed sponsor is Nathaniel Jenkins, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 9 conditions, with Sleep appearing as the primary indexed condition, and to 1 intervention - of which Cognitive Behavioral Therapy for Insomnia (CBT-i) is the first listed.
NCT06454344 reports 1 study location spanning 1 distinct geographic area - top geographies include Iowa.
Frequently Asked Questions
What is clinical trial NCT06454344 about?
NCT06454344 is a clinical study titled "The Iowa ACEs and Sleep Cohort and Manipulating Sleep in Young Adults With ACEs Studies". 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 cro...
What is the current status of trial NCT06454344?
This trial is currently recruiting. It is a NA study. The enrollment target is 70 participants. The study started on 2024-05-01. Estimated completion is 2028-10-31.
What conditions does trial NCT06454344 study?
This clinical trial studies the following conditions: Sleep, Inflammation, Sleep Disturbance, Endothelial Dysfunction, Oxidative Stress.
What interventions are being tested in trial NCT06454344?
The interventions under investigation include: Cognitive Behavioral Therapy for Insomnia (CBT-i) (BEHAVIORAL).
Who is sponsoring clinical trial NCT06454344?
This trial is sponsored by Nathaniel Jenkins, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06454344 being conducted?
This trial has 1 study location across Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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