NCT04737200

The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Intensive care unit (ICU) environments do not support sleep or preserve circadian rhythms of postoperative critically ill patients. Among the contributing factors is the common practice of administering nutrition support through feeding tubes overnight. The overall objective of the study is to examine a novel dimension of clinical nutrition by determining whether enhancing sleep quality and preserving robust circadian rhythms through daytime instead of overnight feeds will attenuate inflammation and improve cardiometabolic profiles of postoperative cardiac ICU patients on nutrition support. The investigators hypothesize that overnight nutrition support results in fragmented sleep and blunted circadian rhythms and thus represent a modifiable mechanism exacerbating inflammation and cardiometabolic derangements in postoperative cardiac patients. Results of this study will help in the development of evidence-based, cost-efficient, and effective enteral nutrition timing countermeasures against fragmented sleep, disrupted circadian rhythms, inflammation and cardiometabolic derangements and potentially modify the current widespread practice of overnight nutrition likely affecting 250,000 hospital admissions annually in the United States.

Conditions

• Feeding Patterns
• Sleep
• Glucose Intolerance

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Time-of-day of enteral nutrition provision (daytime first)	Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.
DIETARY_SUPPLEMENT	Time-of-day of enteral nutrition provision (nighttime first)	Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.

Timeline

• Start date: 2022-02-08
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2021-02-03
• Last updated: 2025-05-08

Locations

1 site across 1 country: United States