Nutrition Timing for Sleep Disruption in ICU Patients

Overseen By Hassan S Dashti

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Benzodiazepines, Antipsychotics

Disqualifiers: Blind, Pregnant, Renal failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 days

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if changing the timing of nutrition—providing it during the day instead of at night—can improve sleep quality and health in ICU patients after heart surgery. Researchers are testing whether daytime eating can stabilize natural body rhythms and reduce inflammation and other health issues. Participants will begin with either daytime or nighttime nutrition, with a short break in between. This trial may suit adults scheduled for heart surgery who will remain in the ICU for more than two days. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance recovery and well-being for future patients.

Will I have to stop taking my current medications?

The trial requires that participants do not take benzodiazepines or antipsychotics. If you are on these medications, you would need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that adjusting the timing of nutrition for ICU patients might improve their health. Studies have examined the benefits of feeding patients during the day versus at night.

Daytime feeding may help patients' bodies process nutrients more effectively and maintain regular sleep-wake cycles, which are often disrupted in the ICU.

Conversely, nighttime feeding might impact sleep quality. Some studies suggest potential risks, but further research is needed to fully understand these effects.

Overall, both daytime and nighttime feeding schedules have been studied for their safety and benefits. While each has potential advantages, the evidence remains inconclusive. These studies aim to ensure that any feeding schedule used is safe and well-tolerated for patients in critical condition. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring nutrition timing for sleep disruption in ICU patients because it could reveal how feeding schedules impact sleep quality and recovery. Unlike traditional treatments that focus on medication to manage sleep, this approach examines how the timing of enteral feeding—whether during the day or night—might influence patients’ sleep patterns and overall healing. By understanding whether daytime or nighttime feeding offers better outcomes, this study aims to improve patient care and potentially enhance recovery rates in the ICU.

What evidence suggests that modifying the timing of enteral nutrition could enhance sleep quality in ICU patients?

Research has shown that adjusting the timing of nutrition for ICU patients can enhance sleep and maintain the body's natural rhythm. This trial will compare two approaches: one group will start with daytime cycled enteral feeds, while the other will begin with nighttime cycled enteral feeds. Studies have found that providing nutrition during the day, rather than at night, can improve sleep quality and overall health. This method, known as chrononutrition, helps regulate the body's natural cycles and may reduce inflammation while improving heart and metabolic health. Although nighttime feeding can meet nutritional needs, it might disrupt sleep and natural body rhythms. Previous research suggests that daytime feeding could be more beneficial for the recovery and well-being of critical care patients. ^{1 5 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are scheduled for cardiac surgery and will stay in the ICU for more than 48 hours. They must be able to consent and follow study rules. It's not open to those with severe liver or kidney issues, dietary limits that prevent tube feeding, certain brain damage, gut absorption problems, gallbladder disease or pancreatitis, chronic use of specific sedatives or antipsychotics, sensory impairments, pregnant/nursing women, or unsafe conditions for tube feeding.

Inclusion Criteria

I am scheduled for heart surgery and will stay in the ICU for more than 48 hours afterwards.

Able and willing to give consent and comply with study procedures

Exclusion Criteria

I am on long-term medication for anxiety or psychosis.

I have a history of problems absorbing food, or issues with my gallbladder or pancreas.

I do not require dialysis and my liver function score is 7 or less.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive either daytime or nighttime cycled enteral feeds for 12 hours, followed by a 24-hour washout period, then switch to the opposite feeding schedule for another 12 hours.

2 days

Continuous monitoring during ICU stay

Follow-up

Participants are monitored for changes in sleep quality, circadian rhythms, inflammation, and cardiometabolic profiles after the treatment phase.

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Time-of-day of enteral nutrition provision (daytime first)
• Time-of-day of enteral nutrition provision (nighttime first)

Trial Overview The study tests if changing when patients get their tube-fed nutrition (from nighttime to daytime) can improve sleep quality and maintain natural body rhythms while reducing inflammation and improving heart-related health markers in post-surgery ICU patients.

How Is the Trial Designed?

Group I: Nighttime cycled enteral feeds first Experimental Treatment 1 Intervention

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.

Group II: Daytime cycled enteral feeds first Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Restoring circadian rhythms in critically ill patients may improve health outcomes and recovery, particularly through interventions like optimizing feeding times to align with individual day-night cycles.

Time-restricted feeding could serve as a potential strategy to enhance immune response by re-establishing circadian patterns, although further research is needed to determine the best approaches for implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding and the realignment of biological rhythms: translational opportunities and challenges. Sunderram, J., Sofou, S., Kamisoglu, K., et al.[2021]

Critically ill patients often experience gastrointestinal dysfunction, and while enteral nutrition is recommended within 24-48 hours, it may not be suitable for those with acute gastrointestinal injury due to potential negative effects on recovery.

The authors suggest implementing trophic feeding after 72 hours as a strategy to partially rest the gut, which could help protect the intestine and improve outcomes for patients with acute gastrointestinal injury during critical illness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gut rest strategy and trophic feeding in the acute phase of critical illness with acute gastrointestinal injury. Zhang, D., Li, H., Li, Y., et al.[2020]

A study of 136,667 adult patients revealed that both post-ICU and non-ICU patients are often inadequately fed, with about two-thirds of those eating less than half a meal not receiving any form of nutritional support like enteral or parenteral nutrition.

Post-ICU patients were 1.3 to 2.0 times more likely to receive nutritional support compared to non-ICU patients, highlighting the need for improved nutritional therapy for all patients, especially those with insufficient food intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

More Nutritional Support on the Wards after a Previous Intensive Care Unit Stay: A nutritionDay Analysis in 136,667 Patients. Fischer, A., Veraar, C., Worf, I., et al.[2023]

Starting enteral nutrition immediately after admission to the ICU using a nasojejunal tube significantly improves serum albumin and prealbumin levels compared to starting nutrition 24 to 48 hours later, based on a study of 100 critically ill patients.

Initiating enteral nutrition early also leads to shorter ICU stays and ventilator times, while reducing complications like gastric retention and pulmonary infections, highlighting its efficacy in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the Initiation Time of Enteral Nutrition for Critically Ill Patients: At Admission vs. 24 to 48 Hours after Admission. Yu, A., Xie, Y., Zhong, M., et al.[2022]

This systematic review of 11 studies, including randomized controlled trials and cohort studies, found no significant benefit of early enteral nutrition (EN) on short-term mortality in critically ill sepsis patients.

While early EN was associated with a higher risk of intestinal-related complications, the evidence was inconclusive and highlighted the need for better-defined studies due to inconsistencies and biases in the existing research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Early Enteral Nutrition on Clinical Outcomes in Critically Ill Sepsis Patients: A Systematic Review. Moon, SJ., Ko, RE., Park, CM., et al.[2023]

After modifying the nutrition support protocol in the ICU, the percentage of patients receiving enteral nutrition (EN) within 72 hours of admission increased significantly from 64% to 88%.

The overall amount of nutrition provided enterally also increased, leading to a marked decline in the use of parenteral nutrition, although the goal of meeting calculated nutrition requirements was achieved later, by Day 7 instead of Day 4.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects on nutritional care practice after implementation of a flow chart-based nutrition support protocol in an intensive care unit. Wikjord, K., Dahl, V., Søvik, S.[2021]

In a study of 34 individuals aged 52 to 80, those receiving intermittent enteral nutrition showed significantly higher energy expenditure and oxygen consumption compared to those on continuous feeding, indicating a potential advantage of intermittent feeding methods.

Both feeding methods demonstrated circadian variations in energy expenditure and oxygen consumption, suggesting that multiple measurements throughout the day are necessary to accurately assess a patient's nutritional needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian rhythm of energy expenditure and oxygen consumption. Leuck, M., Levandovski, R., Harb, A., et al.[2014]

In a study of 26 hospitalized patients receiving enteral nutrition (EN), the actual calories delivered were significantly higher (mean 1678 kcal) than those prescribed (mean 1489 kcal), indicating a discrepancy of 5%–21% due to feeding pump inaccuracies.

The results suggest that a volume-based ordering system for EN may provide more accurate delivery compared to the traditional rate-based system, which could improve patient nutrition management in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivered volumes of enteral nutrition exceed prescribed volumes. Walker, RN., Utech, A., Velez, ME., et al.[2017]

Circadian rhythms, which influence metabolic processes, are significantly disrupted during critical illness, affecting recovery in the ICU.

While intermittent feeding strategies have been compared to continuous feeding, no clear benefits on metabolic outcomes like glycaemic control or muscle mass have been observed, indicating that more research is needed to understand their impact on circadian rhythms and recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent feeding and circadian rhythm in critical illness. Kouw, IWK., Heilbronn, LK., van Zanten, ARH.[2023]

Early Enteral Nutrition (EN) initiated within 24-48 hours of ICU admission significantly improves clinical outcomes for critically ill patients, including reduced hospitalization time and lower rates of morbidity and mortality.

Nurse-led protocols for early EN are effective in achieving daily calorie targets, highlighting the importance of timely nutritional support in managing hypercatabolism in critically ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Enteral Nutrition Met Calories Goals Led by Nurse on Improve Clinical Outcome: A Systematic Scoping Review. Koontalay, A., Suksatan, W., Teranuch, A.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12425950/

Daytime only or time restricted feeding in critically ill patients Time-restricted feeding has been shown to be beneficial to long-term health. Critically ill patients admitted to intensive care units (ICUs) are ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04737200

The Impact of Overnight Nutrition Support on Sleep and ... The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, ...

3. academic.oup.com academic.oup.com/nutritionreviews/article/83/3/e1146/7696968

Chrononutrition in Critical Illness | Nutrition Reviews The purpose of this review was to discuss the role of chrononutrition in regulating biological rhythms in critical illness, and its impact on clinical outcomes.

4. withpower.com withpower.com/trial/phase-glucose-intolerance-9-2021-e9478

Nutrition Timing for Sleep Disruption in ICU Patients This trial aims to determine if changing the timing of nutrition—providing it during the day instead of at night—can improve sleep quality and health in ICU ...

5. trialx.com trialx.com/clinical-trials/listings/268510/the-impact-of-overnight-nutrition-support-on-sleep-and-circadian-rhythm-disruption-in-the-icu/

The Impact of Overnight Nutrition Support on Sleep and ... The purpose of this study is to determine whether modifying the timing of nutrition support from overnight to daytime enhances sleep quality, ...

6. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-024-04994-0

Feeding critically ill patients at the right time of day - Critical Care Supporting the circadian health of critically ill patients through modern feeding schedules has the potential to improve metabolic outcomes by ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05627167

Daytime Cyclic Enteral Nutrition Versus Standard ... Investigator hypothetises that diurnal cyclic enteral nutrition may improve the prognosis of severe intensive care patients compared to continuous enteral ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2161831324001790

Nine Myths about Enteral Feeding in Critically Ill Adults We outlined 9 common intensive care unit (ICU) nutrition misconceptions and our recommendations to optimize enteral nutrition in critically ill patients.