Delirium in Old Age
Conditions
Keywords
Delirium, Insomnia, Ramelteon
Brief 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.
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.
Interventions
DRUGRamelteon
Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first
DRUGPlacebo
Placebo, 1 tablet orally at 21:00 or until discharge whichever comes first
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of delirium | 7 days or less depending on the length of hospital stay | Incidence of delirium measured by DRS-98R |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of delirium | 7 days or less depending on the length of hospital stay | Decreased mean DRS-98R score |
| Sleep improvement | 7 days or less depending on the length of hospital stay | Improvement in sleep metrics: increased duration of sleep as measured by Actigraphy |
Countries
United States
Outcome results
None listed