The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Time-of-day of enteral nutrition provision (daytime first)
Dietary supplementEnteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.
Time-of-day of enteral nutrition provision (nighttime first)
Dietary supplementEnteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Nighttime cycled enteral feeds firstExperimental treatment 1 intervention
Group B: Daytime cycled enteral feeds firstExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.2
Circadian rhythms amplitude
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 outcomes
1
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.
Time frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.2
Total sleep time
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.3
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.
Time frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.4
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.
Time frame
Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov