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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03355053
The ClinicalTrials.gov registry entry for NCT03355053 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 522 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,163-participant average among 151 other Sleep trials with a reported enrollment target (87% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.