Randomized, Double-blind Trial of Daridorexant to Prevent Delirium After Heart Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Delirium
研究概览
简要总结
The goal of this phase 2 clinical trial is to demonstrate the feasibility of the current study methods and obtain preliminary data for an adequately powered trial of daridorexant with the aim of preventing delirium after heart surgery. The main aims this feasibility trial aims to answer are to demonstrate: (1) the feasibility of study recruitment; (2) the ability deliver study compounds to subjects according to the proposed methods; and (3) completeness of data capture; and (4) recording of potential adverse events.
Participants will: (1) complete a baseline visit; (2) take the study drug--either daridorexant or placebo--each of the first 3 nights after heart surgery; and (3) be evaluated for sleep and delirium each of the first three days after heart surgery.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having surgical aortic valve replacement or coronary artery bypass graft surgery at Strong Memorial Hospital
- •Can provide informed consent
- •Able to speak, read, and write English
- •Family member or close friend available for collateral
排除标准
- •Prior heart surgery
- •Infectious endocarditis
- •Emergency surgery
- •Delirium at baseline
- •Auditory/visual impairment preventing study procedures
- •Active alcohol or substance misuse
- •Psychotic disorder
- •Dementia-level deficits
- •Use of a sleep aid before surgery
- •Use of a strong 3A4 inhibitor
- •Intolerance to daridorexant
- •Severe kidney or liver impairment
- •Narcolepsy
- •Any condition that, in the opinion of the PI, compromises patient safety or data quality if enrolled in the study
研究组 & 干预措施
Daridorexant
Oral daridorexant 50 mg (or 25 mg, if taking a moderate 3A4 inhibitor) each of the first three nights after heart surgery.
干预措施: Daridorexant 50 mg (Drug)
Placebo
Oral matching placebo each of the first three nights after heart surgery.
干预措施: Placebo (Other)
结局指标
主要结局
Delirium
时间窗: First 3 days after surgery
In this feasibility trial, the primary outcome is rate of completion for delirium assessments--not whether patients developed delirium or the scores on delirium assessments. We aimed to evaluate subjects for delirium on each of the first three days after heart surgery using the Delirium Rating Scale, Revised-98, and the 3-minute Diagnostic Interview for the Confusion Assessment Method. Delirium based on DSM-5-TR diagnostic criteria would be diagnosed using the information from these two assessments. Below we report the number of subjects evaluated on each of the postoperative days.
次要结局
- Sleep Disturbance(First 3 days after surgery)
研究者
Mark Oldham
Associate Professor of Psychiatry
University of Rochester