Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA.
Medical Biodynamics Center, Massachusetts General Hospital, Boston, Massachusetts, USA.
BMJ Open. 2024 Apr 19;14(4):e080796. doi: 10.1136/bmjopen-2023-080796.
Surgical patients over 70 experience postoperative delirium (POD) complications in up to 50% of procedures. Sleep/circadian disruption has emerged as a potential risk factor for POD in epidemiological studies. This protocol presents a single-site, prospective observational study designed to examine the relationship between sleep/circadian regulation and POD and how this association could be moderated or mediated by Alzheimer's disease (AD) pathology and genetic risk for AD.
Study staff members will screen for eligible patients (age ≥70) seeking joint replacement or spinal surgery at Massachusetts General Hospital (MGH). At the inclusion visit, patients will be asked a series of questionnaires related to sleep and cognition, conduct a four-lead ECG recording and be fitted for an actigraphy watch to wear for 7 days before surgery. Blood samples will be collected preoperatively and postoperatively and will be used to gather information about AD variant genes (-ε4) and AD-related pathology (total and phosphorylated tau). Confusion Assessment Method-Scale and Montreal Cognitive Assessment will be completed twice daily for 3 days after surgery. Seven-day actigraphy assessments and Patient-Reported Outcomes Measurement Information System questionnaires will be performed 1, 3 and 12 months after surgery. Relevant patient clinical data will be monitored and recorded throughout the study.
This study is approved by the IRB at MGH, Boston, and it is registered with the US National Institutes of Health on ClinicalTrials.gov (NCT06052397). Plans for dissemination include conference presentations at a variety of scientific institutions. Results from this study are intended to be published in peer-reviewed journals. Relevant updates will be made available on ClinicalTrials.gov.
NCT06052397.
70 岁以上的手术患者在多达 50%的手术中会出现术后谵妄（POD）并发症。流行病学研究表明，睡眠/昼夜节律紊乱已成为 POD 的一个潜在危险因素。本方案介绍了一项单站点前瞻性观察研究，旨在研究睡眠/昼夜节律调节与 POD 之间的关系，以及这种关联如何被阿尔茨海默病（AD）病理和 AD 的遗传风险所调节或介导。
研究人员将在马萨诸塞州综合医院（MGH）筛选出接受关节置换或脊柱手术的年龄≥70 岁的合格患者。在纳入访问时，患者将被问及一系列与睡眠和认知相关的问卷，进行 4 导联心电图记录，并佩戴活动记录仪，在手术前佩戴 7 天。将在术前和术后采集血样，以收集有关 AD 变体基因（-ε4）和 AD 相关病理（总tau 和磷酸化 tau）的信息。术后 3 天内每天两次完成混淆评估量表和蒙特利尔认知评估。术后 1、3 和 12 个月将进行 7 天的活动记录仪评估和患者报告的结果测量信息系统问卷。在整个研究过程中，将监测并记录相关患者的临床数据。
本研究得到了马萨诸塞州综合医院 IRB 的批准，并在美国国立卫生研究院临床试验.gov（NCT06052397）注册。传播计划包括在各种科学机构的会议上介绍。该研究的结果旨在发表在同行评议的期刊上。将在临床试验.gov 上提供相关更新。
NCT06052397。
