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Search / Trial NCT04737200

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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Feb 1, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Enteral Nutrition Chrononutrition Intensive Care Unit Chronobiology Nutrition Support Sleep

ClinConnect Summary

This clinical trial is studying how changing the timing of nutrition support for patients in the cardiac surgical ICU can impact their sleep and overall health. Specifically, the researchers want to see if providing nutrition during the day instead of overnight helps improve sleep quality, maintain natural body rhythms (called circadian rhythms), and reduce inflammation and other health issues related to metabolism.

To participate in the study, you need to be an adult (18 years or older) who is scheduled for heart surgery and will stay in the ICU for more than 48 hours after the operation. Unfortunately, people with certain health conditions, such as severe liver or kidney problems, or those who cannot eat through a feeding tube, cannot join. If you decide to participate, you will follow specific procedures, and the team will monitor how the new feeding schedule affects your recovery and well-being. This trial is currently looking for volunteers, so if you’re interested or have questions, feel free to ask your healthcare provider.

Gender

ALL

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
  • Severe deficit due to structural or anoxic brain damage
  • With skin condition that precludes wearing sensors

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

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

Principal Investigator

Massachusetts General Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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