Clinical trial NCT03165695: Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults
Official title: Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Delirium in Old Age
Keywords: Delirium
Insomnia
Ramelteon
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Incidence of delirium
timeFrame: 7 days or less depending on the length of hospital stay
Secondary outcomes:
measure: Severity of delirium
timeFrame: 7 days or less depending on the length of hospital stay
measure: Sleep improvement
timeFrame: 7 days or less depending on the length of hospital stay
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Elizabeth B Klerman, M.D.,PhD
role: PRINCIPAL_INVESTIGATOR
References: