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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Delirium in Old Age

Intervention / Treatment
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* Drug: Ramelteon
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Insomnia, Ramelteon