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Dietary Supplement

Nutrition Timing for Sleep Disruption in ICU Patients

N/A

Recruiting

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

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for a cardiac surgical procedure with planned post-operative admission to the ICU for >48 hours

Adult male or non-pregnant female volunteers (age 18+)

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial will help researchers understand whether changing when patients receive nutrition support affects their sleep, body clock, and inflammation/cardiometabolic health after surgery.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While the trial does not involve drugs with side effects typical of medications, altering feeding times may affect sleep patterns temporarily. Patients might experience discomfort due to changes in usual eating schedules.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am an adult over 18 and not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds.

This trial's timeline: 3 weeks for screening, Varies for treatment, and estimated from data collected 12 hours prior to and the 12 hours during daytime cycled and nighttime cycled enteral feeds. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Circadian rhythms amplitude

Sleep fragmentation

Secondary outcome measures

12 hours average glucose

12 hours average systolic and diastolic blood pressure

Acrophase

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Nighttime cycled enteral feeds firstExperimental Treatment1 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 firstExperimental Treatment1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,941 Previous Clinical Trials

13,200,609 Total Patients Enrolled

10 Trials studying Diabetes

268,276 Patients Enrolled for Diabetes

Hassan S Dashti, Ph.D., R.D.Principal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

20 Total Patients Enrolled

Media Library

Time-of-day of enteral nutrition provision (daytime first) (Dietary Supplement) Clinical Trial Eligibility Overview. Trial Name: NCT04737200 — N/A

Diabetes Research Study Groups: Daytime cycled enteral feeds first, Nighttime cycled enteral feeds first

Diabetes Clinical Trial 2023: Time-of-day of enteral nutrition provision (daytime first) Highlights & Side Effects. Trial Name: NCT04737200 — N/A

Time-of-day of enteral nutrition provision (daytime first) (Dietary Supplement) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04737200 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the enrollment capacity for this medical research endeavor?

"Yes, the data gleaned from clinicaltrials.gov reveals that this investigation is currently recruiting volunteers. This trial was first announced on February 8th 2022 and its details have been last updated as of February 23rd 2022. For now, 60 participants need to be chosen for one medical centre's study group."

Answered by AI

Are there any open slots available to join this research experiment?

"Affirmative, the information contemporary on clinicaltrials.gov indicates that recruitment for this experiment is ongoing. It was initially announced February 8th and last updated two weeks later. 60 participants are required from one location to complete the study."

Answered by AI

What key points are researchers trying to investigate with this investigation?

"This medical trial will evaluate the amplitude of circadian rhythms over a 12-hour period, both during daytime and nighttime cycled enteral feeds. Secondary measurements include serum levels of C-reactive protein, Interleukin-6, and Tumor necrosis factor α as inflammatory biomarkers."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Hassan Dashti 2022. "The Impact of Overnight Nutrition Support on Sleep and Circadian Rhythm Disruption in the ICU". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04737200.