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

• Status: Withdrawn
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.