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

NCT04737200 | Recruiting

• 1 other identifier: 2020P003989
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Feeding Patterns; Sleep; Glucose Intolerance

Keywords

Enteral Nutrition; Chrononutrition; Intensive Care Unit; Chronobiology; Nutrition Support; Sleep

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (13)

• Sleep arousals

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

• Total sleep time

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

• Duration of sleep stages

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

• Sleep midpoint

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

• Acrophase

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

Study Arms (2)

Nighttime cycled enteral feeds first

EXPERIMENTAL

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.

Dietary Supplement: Time-of-day of enteral nutrition provision (nighttime first)

Daytime cycled enteral feeds first

EXPERIMENTAL

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.

Dietary Supplement: Time-of-day of enteral nutrition provision (daytime first)

Interventions

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

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

Daytime cycled enteral feeds first

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

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

Nighttime cycled enteral feeds first

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Related Publications (1)

• Dashti HS, Wang YM, Knauert MP. Feeding critically ill patients at the right time of day. Crit Care. 2024 Jun 24;28(1):206. doi: 10.1186/s13054-024-04994-0. No abstract available.

  PMID: 38915028 RESULT

MeSH Terms

Conditions

Feeding Behavior; Glucose Intolerance

Condition Hierarchy (Ancestors)

Behavior, Animal; Behavior; Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Hassan S Dashti, Ph.D., R.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

617-643-7167; chrononutrition@mgh.harvard.edu

Richa Saxena, Ph.D.

CONTACT

rsaxena@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 3, 2021
• Study Start: February 8, 2022
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)