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NCT05551325 · ClinicalTrials.gov registry record · NA

Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle

A NA study of Critical Illness and Sleep Deprivation, sponsored by Yale University.

Recruiting
Registry status
NA
Development phase
160
Enrollment target
2
Study locations

NCT05551325: Recruiting NA study of Critical Illness and Sleep Deprivation, sponsored by Yale University.

NCT05551325 is a NA study of Critical Illness and Sleep Deprivation that is actively recruiting participants, run by Yale University. The registered enrollment target is 160 participants, below the 3,137-participant average among 91 other Critical Illness trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05551325, a NA study of Critical Illness and Sleep Deprivation, is actively recruiting participants, sponsored by Yale University.

RECRUITING
Registry status
NA
Development phase
160 participants
Enrollment target
2
Study locations

Study Summary

More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule behaviors such as sleep and eating at normal body clock times, which is predicted to improve sleep quality and metabolic function. This project will test the ability of a sleep chronobundle (i.e., sleep promotion and circadian treatment bundle) to normalize circadian alignment and subsequently test if this realignment also improves sleep and metabolism.

Primary Outcome

Individual heart rate nadir compared to population normal nadir of 04:00. Maximum difference +/- 12 hours.

Conditions Studied

Critical Illness Sleep Deprivation Circadian Rhythm Sleep Disorder, Unspecified

Interventions

  • OTHER Chronobundle - light
  • OTHER chronobundle - feeding
  • OTHER chronobundle - mobility
  • OTHER chronobundle - sleep

Study Locations (2)

Connecticut

  • Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at St Raphael's Campus - New Haven
  • Yale New Haven Hospital Medical Intensive Care Unit (YNHH MICU) at York Street - New Haven

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2024-05-13
Est. Completion 2028-06-29
Phase NA
Yale University

1,492 total trials

What NCT05551325 shows while recruiting

NCT05551325 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 3,137-participant average among 91 other Critical Illness trials with a reported enrollment target (95% lower).

The record links to 3 conditions, with Critical Illness appearing as the primary indexed condition, and to 4 interventions - of which Chronobundle - light is the first listed.

NCT05551325 reports a single indexed study location in Connecticut.

Frequently Asked Questions

What is clinical trial NCT05551325 about?

NCT05551325 is a clinical study titled "Reestablishing Sleep and Circadian Alignment in Medical Intensive Care Unit (MICU) Patients Via a Mechanistic RCT of an Sleep Chronobundle". More than 5 million patients are admitted to the intensive care unit every year in the United States; most of these patients experience profound sleep and circadian disruption. Promotion of circadian alignment (i.e., alignment of the body's clocks) would make it possible to strategically schedule be...

What is the current status of trial NCT05551325?

This trial is currently recruiting. It is a NA study. The enrollment target is 160 participants. The study started on 2024-05-13. Estimated completion is 2028-06-29.

What conditions does trial NCT05551325 study?

This clinical trial studies the following conditions: Critical Illness, Sleep Deprivation, Circadian Rhythm Sleep Disorder, Unspecified.

What interventions are being tested in trial NCT05551325?

The interventions under investigation include: Chronobundle - light (OTHER), chronobundle - feeding (OTHER), chronobundle - mobility (OTHER), chronobundle - sleep (OTHER).

Who is sponsoring clinical trial NCT05551325?

This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05551325 being conducted?

This trial has 2 study locations across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05551325's enrollment target sits among peer trials

160 53rd of 91 higher than 38 of 91 other Critical Illness trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Critical Illness trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05551325

Source: ClinicalTrials.gov NCT05551325, the US trial registry maintained by the National Library of Medicine. NCT05551325 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.