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The Effect of Ramelteon on Delirium and Sleep in Patients Admitted to the ICU

NCT03931070 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2024-04-10

No results posted yet for this 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.

Conditions

  • Delirium

Interventions

DRUG

Ramelteon

Patients assigned to Ramelteon group will receive 8mg of Ramelteon every night throughout the hospitalization or up to 30 days, whichever is sooner.

DRUG

Placebo - Cap

Patients assigned to Placebo group will receive placebo pill that is indistinguishable from Ramelteon, every night throughout the hospitalization or up to 30 days, whichever is sooner.

Sponsors & Collaborators

  • Rhode Island Hospital

    lead OTHER

Principal Investigators

  • Mitchell M Levy, MD, MCCM, FCCP · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-09
Primary Completion
2022-02-01
Completion
2022-02-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03931070 on ClinicalTrials.gov