The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU (NCT04737200) | Clinical Trial Compass
RecruitingNot Applicable
The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
United States30 participantsStarted 2022-02-08
Plain-language summary
The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, preserves circadian rhythms, and improves overall inflammation and cardiometabolic profiles in postoperative patients in the cardiac surgical ICU on enteral nutrition.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult male or non-pregnant female volunteers (age 18+)
* Scheduled for a cardiac surgical procedure with planned post-operative admission to the ICU for \>48 hours
* Able and willing to give consent and comply with study procedures
Exclusion Criteria:
* Blind, deaf or unable to speak English
* Women who are pregnant or nursing
* Contraindications to safe use enteral nutrition, including gastrointestinal obstruction
* Personal history of intestinal malabsorption, gallbladder disease or pancreatitis
* Dietary restrictions precluding enteral feeds
* Renal and liver failure requiring dialysis or Child-Pugh score \> 7
* Severe deficit due to structural or anoxic brain damage
* With skin condition that precludes wearing sensors
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep fragmentation
Timeframe: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
2
Circadian rhythms amplitude
Timeframe: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.