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

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.

Study Overview

• Status: Withdrawn
• Conditions: Delirium in Old Age
• Intervention / Treatment: Drug: Ramelteon; Drug: Placebo

Detailed Description

Delirium is a common clinical syndrome characterized by acute cognitive dysfunction with core features of inattention, disorganized thinking, perceptual disturbances and sleep-wake cycle disruption. It is typically multifactorial and can be triggered by acute infection, metabolic derangements, surgery, and certain medications. Older adults have a much higher incidence of delirium. Delirium increases in-hospital mortality, length of stay, rate of institutionalization and may cause or exacerbate cognitive impairment. The present pilot study investigates sleep loss as potentially important contributing factors in delirium and an opportunity for intervention. Sleep disruption is prevalent among hospitalized patients. Sufficient sleep is important for recovery from illness, management of pain, wound healing, and a variety of other biologic functions integral to recovery in addition to its putative role in delirium prevention. Melatonin plays an important role in circadian rhythms and sleep-wake cycle regulation. Melatonin secretion is altered in hospitalized older patients in comparison with community-living older individuals. Melatonin and the melatonin-receptor agonist Ramelteon have been studied and have shown promise in delirium prevention, in addition to promoting sleep. We propose to test the use of Ramelteon to decrease delirium and improve sleep/wake cycles in the elderly surgical patients.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ramelteon Arm; Ramelteon tablet 8 mg orally at 21:00 for 7 days or until discharge whichever comes first.	Drug: Ramelteon; Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first; Other Names: Rozerem
Placebo Comparator: Placebo Arm; Sugar pill manufactured to mimic Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first.	Drug: Placebo; Placebo, 1 tablet orally at 21:00 or until discharge whichever comes first

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of delirium	Incidence of delirium measured by DRS-98R	7 days or less depending on the length of hospital stay

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of delirium	Decreased mean DRS-98R score	7 days or less depending on the length of hospital stay
Sleep improvement	Improvement in sleep metrics: increased duration of sleep as measured by Actigraphy	7 days or less depending on the length of hospital stay

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Investigators: Principal Investigator: Elizabeth B Klerman, M.D.,PhD, Brigham and Women's Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: May 22, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (Actual): May 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 19, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Insomnia; Delirium; Ramelteon
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2017P000656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No