Ramelteon vs Placebo for Prevention of Delirium and Improvement of Sleep in Hospitalized Older Adults
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Incidence of delirium
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Placebo Arm
Sugar pill manufactured to mimic Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first.
干预措施: Placebo (Drug)
Ramelteon Arm
Ramelteon tablet 8 mg orally at 21:00 for 7 days or until discharge whichever comes first.
干预措施: Ramelteon (Drug)
结局指标
主要结局
Incidence of delirium
时间窗: 7 days or less depending on the length of hospital stay
Incidence of delirium measured by DRS-98R
次要结局
- Sleep improvement(7 days or less depending on the length of hospital stay)
- Severity of delirium(7 days or less depending on the length of hospital stay)
研究者
Elizabeth B. Klerman
Associate Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital