Skip to main content
OpenTrials
Recruiting

NCT Number: NCT04737200

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Feeding Patterns Behavior Behavior, Animal Feeding Behavior Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases Sleep

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location status: Recruiting

Location contact

Hassan S Dashti

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time-of-day of enteral nutrition provision (daytime first)

Dietary Supplement

Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.

Time-of-day of enteral nutrition provision (nighttime first)

Dietary Supplement

Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.

Primary outcomes

  1. Sleep fragmentation

    Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.

    Sleep fragmentation is defined as the number of shifts from deeper (N2, N3, REM) to lighter (W or N1) sleep stages by hours of sleep. Sleep fragmentation will be assessed objectively through EEG measures.

  2. Circadian rhythms amplitude

    Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

    Amplitude is defined as peak-to-nadir difference in rhythms estimated from body temperature and actigraphy.

Secondary outcomes

  1. Sleep arousals

    Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.

    Sleep arousals is defined as n shifts from N1, N2, N3, REM to wake divided by hours of sleep. Sleep arousals will be assessed objectively through EEG measures.

  2. Total sleep time

    Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.

    Measure of sleep duration and assessed objectively through EEG measures.

  3. Duration of sleep stages

    Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.

    Duration of the following sleep stages will be estimated: N1, N2, N3, REM sleep. Sleep stages will be assessed objectively through EEG measures.

  4. Sleep midpoint

    Time frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.

    Sleep midpoint is defined as the midpoint between start and end of sleep episode. Sleep midpoint will be determined objectively from EEG measures.

  5. Acrophase

    Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

    Acrophase is defined as the time of peak activity.

  6. Midpoint of least-active 5h timing

    Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

    Measure of sleep timing as determined from actigraphy.

  7. Midpoint of most-active 10h timing

    Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

    Measure of sleep timing as determined from actigraphy.

  8. Inactivity duration

    Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

    Duration of inactivity outside of sleep episode as determined from actigraphy.

  9. 12 hours average systolic and diastolic blood pressure

    Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

    Continuously measured using ECG. Systolic and diastolic blood pressure will be averaged during each 12-hour cycled feed.

  10. 12 hours average glucose

    Time frame: Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

    Continuously measured using continuous glucose sensors. Blood glucose will be averaged during each 12-hour cycled feed.

  11. C-reactive protein

    Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.

    The inflammatory biomarker C-reactive protein will be measured from serum.

  12. Interleukin-6

    Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.

    The inflammatory biomarker Interleukin-6 will be measured from serum.

  13. Tumor necrosis factor α

    Time frame: Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.

    The inflammatory biomarker Tumor necrosis factor α will be measured from serum.

Study contacts

Contact information is provided by the study sponsor or research team.

Hassan S Dashti, Ph.D., R.D.

CONTACT

[email protected]

617-643-7167

Richa Saxena, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 3, 2021
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.