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NCT03355053 · ClinicalTrials.gov registry record · Phase 2
Investigation of Sleep in the Intensive Care Unit
A Phase 2 study of Sleep and Delirium, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 522
- Enrollment target
- 1
- Study location
NCT03355053: Completed Phase 2 study of Sleep and Delirium, sponsored by Massachusetts General Hospital.
NCT03355053 is a Phase 2 study of Sleep and Delirium that has completed, run by Massachusetts General Hospital. The registered enrollment target is 522 participants, below the 4,163-participant average among 151 other Sleep trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03355053, a Phase 2 study of Sleep and Delirium, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 522 participants
- Enrollment target
- 1
- Study location
Study Summary
Sleep deprivation is common and often severe in critically ill patients cared for in intensive care units (ICUs) and is hypothesized to be a modifiable risk factor for delirium, which in turn is hypothesized to be a modifiable risk factor for long-term cognitive disability following recovery from critical illness. Dexmedetomidine (Dex) reduces the incidence of delirium in ICU patients by unknown mechanisms. The Investigation of Sleep in the Intensive Care Unit (ICU-SLEEP) Trial aims to determine whether Dex reduces delirium by improving sleep, whether a low- and/or very-low dose continuous infusion of Dex increases delirium-free days more, and the relationship between sleep deprivation in the ICU to long-term cognitive outcomes.
Primary Outcome
In-hospital Delirium-free days (IH-DFDs) are calculated as the sum of days without delirium during the first 14 hospital days from start of infusion in the two Dex treatment arms combined (arms 1 and 2) vs. usual care (arm 3). Delirium is defined as any positive Confusion Assessment Method (CAM) or CAM for the ICU (CAM-ICU) assessment, with each yielding a binary result (1 = delirious/CAM+, 0 = non-delirious/CAM-). For each patient, delirium is assessed twice daily. If a patient has any positive
Interventions
- DRUG Placebo
- DRUG Dexmedetomidine
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 522 participants |
| Start Date | 2018-05-29 |
| Est. Completion | 2023-03-24 |
| Phase | Phase 2 |
What the finished NCT03355053 record still lists
NCT03355053 is an interventional study that assigns participants to a tested intervention. The registered 522 participants enrollment target is mid-sized for trials with a published cap, below the 4,163-participant average among 151 other Sleep trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Sleep appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03355053 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03355053 about?
NCT03355053 is a clinical study titled "Investigation of Sleep in the Intensive Care Unit". Sleep deprivation is common and often severe in critically ill patients cared for in intensive care units (ICUs) and is hypothesized to be a modifiable risk factor for delirium, which in turn is hypothesized to be a modifiable risk factor for long-term cognitive disability following recovery from cr...
What is the current status of trial NCT03355053?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 522 participants. The study started on 2018-05-29. Estimated completion is 2023-03-24.
What conditions does trial NCT03355053 study?
This clinical trial studies the following conditions: Sleep, Delirium.
What interventions are being tested in trial NCT03355053?
The interventions under investigation include: Placebo (DRUG), Dexmedetomidine (DRUG).
Who is sponsoring clinical trial NCT03355053?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03355053 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Sleep
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 NCT03355053's enrollment target sits among peer trials
522 12th of 151 higher than 140 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep 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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