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NCT03931070 · ClinicalTrials.gov registry record · Phase 4
The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU
A Phase 4 study, sponsored by Rhode Island Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 112
- Enrollment target
NCT03931070: Completed Phase 4 study, sponsored by Rhode Island Hospital.
NCT03931070 is a Phase 4 study that has completed, run by Rhode Island Hospital. The registered enrollment target is 112 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03931070, a Phase 4 study, has completed, sponsored by Rhode Island Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 112 participants
- Enrollment target
Study Summary
Delirium is a disturbance in attention and awareness that occurs over a short period of time. Delirium is common in critically ill patients, and poor sleep quality in the intensive care unit (ICU) often worsens delirium. We aim to lower delirium in the intensive care unit (ICU) by using ramelteon, which is a drug used to improve sleep at night.
Primary Outcome
The average number of delirium- and coma-free days as defined by Richmond Agitation-Sedation Scale (RASS) greater than -4 (RASS score is a range from -5 to +4, the lower score indicates comatose state, the higher score indicates more awakeness/agitation) and Confusion Assessment Method in the Intensive Care Unit (CAM-ICU-7) score greater than 3 (CAM-ICU-7 score ranges from 0 to 7, the higher score indicates more severe delirium).
Interventions
- DRUG Placebo - Cap
- DRUG Ramelteon
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2022-02-01 |
| Phase | Phase 4 |
What the finished NCT03931070 record still lists
NCT03931070 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo - Cap is the first listed.
NCT03931070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03931070 about?
NCT03931070 is a clinical study titled "The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU". Delirium is a disturbance in attention and awareness that occurs over a short period of time. Delirium is common in critically ill patients, and poor sleep quality in the intensive care unit (ICU) often worsens delirium. We aim to lower delirium in the intensive care unit (ICU) by using ramelteon, w...
What is the current status of trial NCT03931070?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 112 participants. The study started on 2019-05-09. Estimated completion is 2022-02-01.
What interventions are being tested in trial NCT03931070?
The interventions under investigation include: Placebo - Cap (DRUG), Ramelteon (DRUG).
Who is sponsoring clinical trial NCT03931070?
This trial is sponsored by Rhode Island Hospital, which has 130 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03931070's enrollment target sits among peer trials
112 724th of 2000 higher than 1,275 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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