Melatonin and Sleep in Preventing Delirium in the Hospital: A Randomized Placebo-controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Delirium as measured by CAM Assessment
研究概览
简要总结
Recent data suggests that melatonin, a supplement available over the counter, may help prevent delirium in hospitalized patients. The investigators are hypothesizing that melatonin may help in delirium prevention by improving sleep quality and possibly circadian rhythm cycling in patients who are given the supplement. This pilot study involves a randomized placebo-controlled design in which participants will be randomized to receive either melatonin 3mg orally or placebo orally. Participants in both groups will be fitted with wireless actigraphy devices to obtain objective sleep quality, and will also receive a sleep questionnaire each morning to obtain subjective data on their sleep quality overnight. Delirium will be assessed by floor nurses twice daily using the Confusion Assessment Method (CAM).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65-100 years old
- •Admitted to Scripps Green Hospital
- •Admitted to an Internal Medicine or Medicine Consult Service
- •Expected to have a hospital stay of greater than or equal to 48 hours (patients admitted to "inpatient," not "observation," under Medicare guidelines)
排除标准
- •Cirrhosis of any etiology
- •Admitted for alcohol withdrawal
- •Currently taking a 1st or 2nd generation anti-psychotic
- •Active delirium (i.e., delirium prior to 1st dose of melatonin)
- •Diagnosis of encephalitis
- •History of seizure
研究组 & 干预措施
Placebo Group
Patient in this group will receive a matching placebo pill orally at 9pm.
干预措施: Placebo (Other)
Melatonin Group
Patients in this group will receive melatonin 3mg orally at 9pm.
干预措施: Melatonin (Dietary Supplement)
结局指标
主要结局
Delirium as measured by CAM Assessment
时间窗: Delirium assessments will be made twice daily (am and pm measurements) throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.
Primary outcome is whether patients become delirious, as measured by CAM during their hospital admission.
次要结局
- Subjective sleep quality, measured by Richards-Campbell sleep questionnaire(once daily, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.)
- Objective sleep quality, measured by number of nighttime wakenings(nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.)
- Objective Sleep Quality, measured by nocturnal sleep duration(nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.)
- Objective sleep quality, measured by sleep latency(nightly, throughout the course of the patient's admission, or to the end of a 2 week period of enrollment - whichever comes first.)