The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Primary Purpose
Feeding Patterns, Sleep, Glucose Intolerance
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time-of-day of enteral nutrition provision (daytime first)
Time-of-day of enteral nutrition provision (nighttime first)
Sponsored by
About this trial
This is an interventional supportive care trial for Feeding Patterns focused on measuring Enteral Nutrition, Chrononutrition, Intensive Care Unit, Chronobiology, Nutrition Support, Sleep
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
- Chronic therapy with benzodiazepines and/or antipsychotics
- Severe deficit due to structural or anoxic brain damage
- With skin condition that precludes wearing sensors
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Nighttime cycled enteral feeds first
Daytime cycled enteral feeds first
Arm Description
Patients will start nighttime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start daytime cycled enteral feeds for 12 hours.
Patients will start daytime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start nighttime cycled enteral feeds for 12 hours.
Outcomes
Primary Outcome Measures
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.
Circadian rhythms amplitude
Amplitude is defined as peak-to-nadir difference in rhythms estimated from body temperature and actigraphy.
Secondary Outcome Measures
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.
Total sleep time
Measure of sleep duration and assessed objectively through EEG measures.
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.
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.
Acrophase
Acrophase is defined as the time of peak activity.
Midpoint of least-active 5h timing
Measure of sleep timing as determined from actigraphy.
Midpoint of most-active 10h timing
Measure of sleep timing as determined from actigraphy.
Inactivity duration
Duration of inactivity outside of sleep episode as determined from actigraphy.
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.
12 hours average glucose
Continuously measured using continuous glucose sensors. Blood glucose will be averaged during each 12-hour cycled feed.
C-reactive protein
The inflammatory biomarker C-reactive protein will be measured from serum.
Interleukin-6
The inflammatory biomarker Interleukin-6 will be measured from serum.
Tumor necrosis factor α
The inflammatory biomarker Tumor necrosis factor α will be measured from serum.
Full Information
NCT ID
NCT04737200
First Posted
January 28, 2021
Last Updated
March 13, 2023
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04737200
Brief Title
The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Official Title
The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 8, 2022 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Patterns, Sleep, Glucose Intolerance
Keywords
Enteral Nutrition, Chrononutrition, Intensive Care Unit, Chronobiology, Nutrition Support, Sleep
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nighttime cycled enteral feeds first
Arm Type
Experimental
Arm Description
Patients will start nighttime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start daytime cycled enteral feeds for 12 hours.
Arm Title
Daytime cycled enteral feeds first
Arm Type
Experimental
Arm Description
Patients will start daytime cycled enteral feeds first for 12 hours. Following a 24-hour washout period, patients will then start nighttime cycled enteral feeds for 12 hours.
Intervention Type
Dietary Supplement
Intervention Name(s)
Time-of-day of enteral nutrition provision (daytime first)
Intervention Description
Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.
Intervention Type
Dietary Supplement
Intervention Name(s)
Time-of-day of enteral nutrition provision (nighttime first)
Intervention Description
Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.
Primary Outcome Measure Information:
Title
Sleep fragmentation
Description
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.
Time Frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Title
Circadian rhythms amplitude
Description
Amplitude is defined as peak-to-nadir difference in rhythms estimated from body temperature and actigraphy.
Time Frame
Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Secondary Outcome Measure Information:
Title
Sleep arousals
Description
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.
Time Frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Title
Total sleep time
Description
Measure of sleep duration and assessed objectively through EEG measures.
Time Frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Title
Duration of sleep stages
Description
Duration of the following sleep stages will be estimated: N1, N2, N3, REM sleep. Sleep stages will be assessed objectively through EEG measures.
Time Frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Title
Sleep midpoint
Description
Sleep midpoint is defined as the midpoint between start and end of sleep episode. Sleep midpoint will be determined objectively from EEG measures.
Time Frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.
Title
Acrophase
Description
Acrophase is defined as the time of peak activity.
Time Frame
Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Title
Midpoint of least-active 5h timing
Description
Measure of sleep timing as determined from actigraphy.
Time Frame
Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Title
Midpoint of most-active 10h timing
Description
Measure of sleep timing as determined from actigraphy.
Time Frame
Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Title
Inactivity duration
Description
Duration of inactivity outside of sleep episode as determined from actigraphy.
Time Frame
Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Title
12 hours average systolic and diastolic blood pressure
Description
Continuously measured using ECG. Systolic and diastolic blood pressure will be averaged during each 12-hour cycled feed.
Time Frame
Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Title
12 hours average glucose
Description
Continuously measured using continuous glucose sensors. Blood glucose will be averaged during each 12-hour cycled feed.
Time Frame
Estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.
Title
C-reactive protein
Description
The inflammatory biomarker C-reactive protein will be measured from serum.
Time Frame
Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Title
Interleukin-6
Description
The inflammatory biomarker Interleukin-6 will be measured from serum.
Time Frame
Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
Title
Tumor necrosis factor α
Description
The inflammatory biomarker Tumor necrosis factor α will be measured from serum.
Time Frame
Blood draw scheduled at 8 am and 8 pm on days on daytime cycled and nighttime cycled enteral feeds.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Chronic therapy with benzodiazepines and/or antipsychotics
Severe deficit due to structural or anoxic brain damage
With skin condition that precludes wearing sensors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hassan S Dashti, Ph.D., R.D.
Phone
617-643-7167
Email
chrononutrition@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Richa Saxena, Ph.D.
Email
rsaxena@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan S Dashti, Ph.D., R.D.
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan S Dashti
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
We'll reach out to this number within 24 hrs