Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Delirium in Old Age

In brief

This study evaluates whether Ramelteon can prevent delirium, decrease the severity of incident delirium and improve sleep wake cycle in hospitalized elderly surgical patients. Half of the patients will be assigned to Ramelteon, while other half will be assigned to placebo.

Key facts

Study ID

NCT03165695

Run by

Brigham and Women's Hospital

People needed

0

Starts

2019-12-01

Expected to finish

2019-12-31

Last updated by the study team

2020-01-22

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 65 years of age or older.
• Admitted to BWH vascular surgical service.
• Able to provide informed consent or a surrogate is available to provide informed consent.
• Absence of delirium at time of consent.

You may not qualify if…

• Expected stay or life expectancy less than 48 hours
• Unable to take medications orally
• Advanced liver disease (Child-Pugh class B or worse)
• Active treatment with Fluvoxamine
• Active treatment with antipsychotic medications, benzodiazepines or other hypnotic agents (i.e. Trazodone, Mirtazapine, Zolpidem, Zaleplon)
• Known or suspected diagnosis of Lewy body dementia
• Any dermatological condition that may be aggravated by using a wrist sensor.
• Known pre-existing sleep disorder other than insomnia.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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