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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04737200
Status
Recruiting
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Conditions

  • Feeding Patterns
  • Glucose Intolerance
  • Sleep

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Feb 8, 2022
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Nighttime cycled enteral feeds first
    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.
  • Experimental: Daytime cycled enteral feeds first
    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.

Primary Outcome Measure

Sleep fragmentation [ Time Frame: Approximately 12 hours. Estimated from nighttime sleep following daytime cycled enteral feeds and during nighttime cycled enteral feeds. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Hassan S Dashti

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By research site
Massachusetts General Hospital· Boston, MA

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