A randomized controlled trial to test a behavioral sleep intervention to improve insomnia symptoms in older adults with mild cognitive impairment: Multicomponent Behavioral Sleep Intervention (MBSI) protocol.
A randomized controlled trial to test a behavioral sleep intervention to improve insomnia symptoms in older adults with mild cognitive impairment: Multicomponent Behavioral Sleep Intervention (MBSI) protocol.
复制标题
一项测试行为睡眠干预以改善患有轻度认知障碍的老年人失眠症状的随机对照试验：多成分行为睡眠干预（MBSI）方案。
DOI：
10.1016/j.cct.2023.107137
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发表时间：
2023
影响因子：
2.2
通讯作者：
Hodgson,NancyA
中科院分区：
文献类型：
--
作者：
McPhillips,MirandaV;Li,Junxin;Petrovsky,DarinaV;Gooneratne,NalakaS;Aryal,Subhash;Hodgson,NancyA
背景 患有轻度认知障碍的老年人的失眠症状在生活质量受损、未经治疗的失眠带来的风险以及药物失眠治疗的副作用方面构成了重大的公共健康负担。为了解决目前对患有轻度认知障碍的老年人失眠最有效的非药物治疗的局限性，我们正在进行一项随机试点研究，以在患有轻度认知障碍的老年人样本中测试短暂（4周）、基于片剂的、个性化的、多成分的失眠行为睡眠干预（MBSI），并与睡眠教育对照进行比较。方法参与者将以1:1的比例随机分配到干预组或对照组。两组将完成 3 次虚拟研究数据收集访问：基线、干预后 4 周随访和干预后 12 周随访。为期 4 周的干预措施的关键组成部分包括睡眠卫生教育、刺激白天有意义的活动以及促进夜间放松疗法。我们将确定 MBSI 与睡眠教育在睡眠相关结果和健康相关生活质量方面的初步即时（4 周）和持续疗效（12 周）。此外，我们将使用标准化问卷和炎症生物标志物探索干预措施影响睡眠和健康相关生活质量的机制。结果（不适用）。讨论拟议项目的研究结果将为未来更大规模的临床试验提供信息，并可能为患有轻度认知障碍的老年人提供一种新颖和创新的方法，以实现更好的睡眠和健康相关的生活质量结果。
BackgroundInsomnia symptoms in older adults with mild cognitive impairment represent a significant public health burden in terms of impaired quality of life, risks from untreated insomnia, and adverse effects from pharmaceutical insomnia treatment. To address current limitations in the most effective non-pharmacological treatments for insomnia in older adults with mild cognitive impairment, we are conducting a randomized pilot study to test a brief (4- week), tablet-based, personalized, multicomponent behavioral sleep intervention (MBSI) for insomnia, compared to a sleep education control, in a sample of older adults with mild cognitive impairment.MethodsParticipants will be randomized in a 1:1 ratio to intervention or control group. Both groups will complete three virtual study data collection visits: baseline, 4-week post-intervention, and 12-week post-intervention follow-up. Key components of the 4-week intervention include sleep hygiene education, stimulating meaningful activity during the day and promoting relaxation therapy at night. We will determine preliminary immediate (4-week) and sustained efficacy (12-week) of MBSI compared to sleep education on sleep related outcomes and health related quality of life. Additionally, we will explore mechanisms by which the intervention affects sleep and health related quality of life using standardized questionnaires and inflammatory biomarkers.Results(N/A).DiscussionThe findings of the proposed project will inform future, larger scale clinical trials and may provide a novel and innovative way for older adults with mild cognitive impairment to achieve better sleep and health-related quality of life outcomes.