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

Sleep Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04737200
• Other study ID #: 2020P003989
• Status: Recruiting
• Phase: N/A
• Start date: February 8, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: Hassan S Dashti, Ph.D., R.D.
• Phone: 617-643-7167
• Email: chrononutrition[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

• Chronic therapy with benzodiazepines and/or antipsychotics

• Severe deficit due to structural or anoxic brain damage

• With skin condition that precludes wearing sensors

Related Conditions & MeSH terms

• Feeding Patterns
• Glucose Intolerance
• Sleep

Intervention

Dietary Supplement:
• Time-of-day of enteral nutrition provision (daytime first)
Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.
• Time-of-day of enteral nutrition provision (nighttime first)
Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep fragmentation	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.	Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Primary	Circadian rhythms amplitude	Amplitude is defined as peak-to-nadir difference in rhythms estimated from body temperature and actigraphy.	Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary	Sleep arousals	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.	Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Secondary	Total sleep time	Measure of sleep duration and assessed objectively through EEG measures.	Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Secondary	Duration of sleep stages	Duration of the following sleep stages will be estimated: N1, N2, N3, REM sleep. Sleep stages will be assessed objectively through EEG measures.	Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Secondary	Sleep midpoint	Sleep midpoint is defined as the midpoint between start and end of sleep episode. Sleep midpoint will be determined objectively from EEG measures.	Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Secondary	Acrophase	Acrophase is defined as the time of peak activity.	Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary	Midpoint of least-active 5h timing	Measure of sleep timing as determined from actigraphy.	Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary	Midpoint of most-active 10h timing	Measure of sleep timing as determined from actigraphy.	Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary	Inactivity duration	Duration of inactivity outside of sleep episode as determined from actigraphy.	Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary	12 hours average systolic and diastolic blood pressure	Continuously measured using ECG. Systolic and diastolic blood pressure will be averaged during each 12-hour cycled feed.	Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary	12 hours average glucose	Continuously measured using continuous glucose sensors. Blood glucose will be averaged during each 12-hour cycled feed.	Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary	C-reactive protein	The inflammatory biomarker C-reactive protein will be measured from serum.	Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Secondary	Interleukin-6	The inflammatory biomarker Interleukin-6 will be measured from serum.	Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Secondary	Tumor necrosis factor a	The inflammatory biomarker Tumor necrosis factor a will be measured from serum.	Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.