NCT04737200 The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
| NCT ID | NCT04737200 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Feeding Patterns |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-02-08 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2022-02-08 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Hassan S Dashti, Ph.D., R.D.
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT04737200 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Feeding Patterns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04737200 currently recruiting?
Yes, NCT04737200 is actively recruiting participants. Contact the research team at chrononutrition@mgh.harvard.edu for enrollment information.
Where is the NCT04737200 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04737200 clinical trial?
NCT04737200 is sponsored by Massachusetts General Hospital. The principal investigator is Hassan S Dashti, Ph.D., R.D. at Massachusetts General Hospital. The trial plans to enroll 30 participants.