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与阿尔茨海默病和痴呆症相关的睡眠障碍管理:ClinicalTrials.gov的最新综述

Management of sleep disturbance related to Alzheimer disease and dementia: An updated review of ClinicalTrials.gov.

作者信息

Aldurdunji Mohammed M

机构信息

Pharmaceutical Practices Department, College of Pharmacy, Umm Al-Qura University, Makkah, Saudi Arabia.

出版信息

Medicine (Baltimore). 2025 Aug 8;104(32):e43725. doi: 10.1097/MD.0000000000043725.

Abstract

Sleep disturbances are prevalent and commonly associated with Alzheimer disease (AD) and other forms of dementia, significantly impacting the quality of life for patients and their caregivers. These disturbances not only exacerbate cognitive decline but also contribute to the overall progression of neurodegenerative diseases. This review highlights the importance of managing sleep disturbances in patients with AD and dementia by analyzing completed clinical trials on this topic. A comprehensive search of the ClinicalTrials.gov database was performed on July 21, 2024, to identify all relevant clinical trials evaluating the efficacy of interventions for managing sleep disturbances in this population. Trials were included if they focused specifically on interventions for sleep disturbances in patients diagnosed with AD or dementia, were completed, and had results available. A total of 9 interventional and completed clinical trials related to sleep disturbance and AD were identified, involving 1139 participants. Three of the studies were nonpharmacological interventions, while 6 were pharmacological. Four studies were phase 2 clinical trials, and 1 was phase 3; the remaining were categorized as nonpharmacological. All studies were completed and had reported results. This review identifies a limited number of clinical trials addressing sleep disturbances in AD and dementia using either pharmacological or nonpharmacological interventions. Further clinical trials are recommended due to the impact of sleep disturbances on the quality of life for both patients and caregivers.

摘要

睡眠障碍很普遍,通常与阿尔茨海默病(AD)和其他形式的痴呆症相关,严重影响患者及其护理人员的生活质量。这些障碍不仅会加剧认知衰退,还会促使神经退行性疾病整体进展。本综述通过分析关于该主题的已完成临床试验,强调了管理AD和痴呆症患者睡眠障碍的重要性。2024年7月21日对ClinicalTrials.gov数据库进行了全面搜索,以识别所有评估干预措施对该人群睡眠障碍管理效果的相关临床试验。如果试验专门针对诊断为AD或痴呆症患者的睡眠障碍干预措施、已完成且有可用结果,则纳入试验。共识别出9项与睡眠障碍和AD相关的干预性且已完成的临床试验,涉及1139名参与者。其中3项研究为非药物干预,6项为药物干预。4项研究为2期临床试验,1项为3期;其余归类为非药物试验。所有研究均已完成并报告了结果。本综述发现,使用药物或非药物干预措施解决AD和痴呆症患者睡眠障碍的临床试验数量有限。鉴于睡眠障碍对患者和护理人员生活质量的影响,建议进一步开展临床试验。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b04/12338198/fbb5d90e20f3/medi-104-e43725-g001.jpg

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