Gabb Victoria Grace, Blackman Jonathan, Morrison Hamish Duncan, Biswas Bijetri, Li Haoxuan, Turner Nicholas, Russell Georgina M, Greenwood Rosemary, Jolly Amy, Trender William, Hampshire Adam, Whone Alan, Coulthard Elizabeth
Bristol Medical School, University of Bristol, Bristol, United Kingdom.
Neurology Department, Bristol Brain Centre, North Bristol NHS Trust, Bristol, United Kingdom.
JMIR Res Protoc. 2024 Mar 22;13:e52652. doi: 10.2196/52652.
Sleep disturbances are a potentially modifiable risk factor for neurodegenerative dementia secondary to Alzheimer disease (AD) and Lewy body disease (LBD). Therefore, we need to identify the best methods to study sleep in this population.
This study will assess the feasibility and acceptability of various wearable devices, smart devices, and remote study tasks in sleep and cognition research for people with AD and LBD.
We will deliver a feasibility and acceptability study alongside a prospective observational cohort study assessing sleep and cognition longitudinally in the home environment. Adults aged older than 50 years who were diagnosed with mild to moderate dementia or mild cognitive impairment (MCI) due to probable AD or LBD and age-matched controls will be eligible. Exclusion criteria include lack of capacity to consent to research, other causes of MCI or dementia, and clinically significant sleep disorders. Participants will complete a cognitive assessment and questionnaires with a researcher and receive training and instructions for at-home study tasks across 8 weeks. At-home study tasks include remote sleep assessments using wearable devices (electroencephalography headband and actigraphy watch), app-based sleep diaries, online cognitive assessments, and saliva samples for melatonin- and cortisol-derived circadian markers. Feasibility outcomes will be assessed relating to recruitment and retention, data completeness, data quality, and support required. Feedback on acceptability and usability will be collected throughout the study period and end-of-study interviews will be analyzed using thematic analysis.
Recruitment started in February 2022. Data collection is ongoing, with final data expected in February 2024 and data analysis and publication of findings scheduled for the summer of 2024.
This study will allow us to assess if remote testing using smart devices and wearable technology is a viable alternative to traditional sleep measurements, such as polysomnography and questionnaires, in older adults with and without MCI or dementia due to AD or LBD. Understanding participant experience and the barriers and facilitators to technology use for research purposes and remote research in this population will assist with the development of, recruitment to, and retention within future research projects studying sleep and cognition outside of the clinic or laboratory.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/52652.
睡眠障碍是继发于阿尔茨海默病(AD)和路易体病(LBD)的神经退行性痴呆潜在的可改变风险因素。因此,我们需要确定研究该人群睡眠的最佳方法。
本研究将评估各种可穿戴设备、智能设备以及远程研究任务在AD和LBD患者睡眠与认知研究中的可行性和可接受性。
我们将开展一项可行性和可接受性研究,同时进行一项前瞻性观察队列研究,在家庭环境中纵向评估睡眠和认知情况。年龄在50岁以上、因可能的AD或LBD被诊断为轻度至中度痴呆或轻度认知障碍(MCI)的成年人以及年龄匹配的对照组符合条件。排除标准包括无研究同意能力、MCI或痴呆的其他病因以及具有临床意义的睡眠障碍。参与者将与研究人员一起完成认知评估和问卷调查,并接受为期8周的家庭研究任务培训和指导。家庭研究任务包括使用可穿戴设备(脑电图头带和活动记录仪手表)进行远程睡眠评估、基于应用程序的睡眠日记、在线认知评估以及用于褪黑素和皮质醇衍生昼夜节律标志物的唾液样本采集。将评估与招募和保留、数据完整性、数据质量以及所需支持相关的可行性结果。在整个研究期间收集关于可接受性和可用性的反馈,并使用主题分析对研究结束时的访谈进行分析。
招募工作于2022年2月开始。数据收集正在进行中,预计最终数据于2024年2月获得,数据分析和研究结果发表计划于2024年夏季进行。
本研究将使我们能够评估在患有和未患有因AD或LBD导致的MCI或痴呆的老年人中,使用智能设备和可穿戴技术进行远程测试是否是传统睡眠测量方法(如多导睡眠图和问卷调查)的可行替代方法。了解参与者的体验以及该人群中用于研究目的的技术使用和远程研究的障碍与促进因素,将有助于未来在诊所或实验室之外研究睡眠和认知的研究项目的开展、招募和保留。
国际注册报告标识符(IRRID):DERR1-10.2196/52652。