NCT05069428 Delirium Reduction With Ramelteon
| NCT ID | NCT05069428 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Centennial Medical Center |
| Condition | Delirium |
| Study Type | INTERVENTIONAL |
| Enrollment | 506 participants |
| Start Date | 2023-03-26 |
| Primary Completion | 2025-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 506 participants in total. It began in 2023-03-26 with a primary completion date of 2025-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The overall purpose of this study is to identify a medication that might treat and/or prevent delirium in intensive care unit (ICU). Currently, there is no proven medical therapy for prevention or treatment of delirium. Ramelteon is a medication approved for insomnia. We hypothesize that ramelteon may help regulate the day/night cycle and decrease ICU delirium.
Eligibility Criteria
Inclusion Criteria: * Medical or surgical ICU patient * Ability to take oral or nasogastric tube within 48 hours of admission to ICU * Expected ICU length of stay and life expectancy at least 48 hours * Patient or POA capable of signing informed consent within 48 hours of ICU admission Exclusion Criteria: * Past medical history includes cirrhosis * Active alcohol withdrawal * Patients taking fluvoxamine prior to admission * Self-reported hypersensitivity to ramelteon * Incarcerated patients * Pregnant patients * Patients with acute neurological conditions including brain abscess, head bleed, meningitis * Patients who are transferred from an outside hospital where they have resided for greater than 4 days * Non-English speaking patients * Hearing-impaired patients requiring sign language for communication * Visually-impaired patients
Contact & Investigator
Jennifer Johnson, MD
PRINCIPAL INVESTIGATOR
Centennial Medical Center
Frequently Asked Questions
Who can join the NCT05069428 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05069428 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05069428 currently recruiting?
Yes, NCT05069428 is actively recruiting participants. Contact the research team at jennifer.johnson19@hcahealthcare.com for enrollment information.
Where is the NCT05069428 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05069428 clinical trial?
NCT05069428 is sponsored by Centennial Medical Center. The principal investigator is Jennifer Johnson, MD at Centennial Medical Center. The trial plans to enroll 506 participants.