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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: Recruiting NA study of Sleep and Inflammation, sponsored by Nathaniel Jenkins.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The brachial artery flow-mediated dilation (FMD) technique, a non-invasive bioassay of endothelium-dependent vasodilatory function, will be used as the primary determinant of in-vivo vascular endothelial function.
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 |
What NCT06454344 shows while recruiting
NCT06454344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT06454344's enrollment target sits among peer trials
70 82nd of 151 higher than 68 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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