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一项旨在测试行为睡眠干预措施以改善轻度认知障碍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。

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.

机构信息

School of Nursing, University of Pennsylvania, USA.

School of Nursing, John Hopkins University, USA.

出版信息

Contemp Clin Trials. 2023 Apr;127:107137. doi: 10.1016/j.cct.2023.107137. Epub 2023 Feb 28.

Abstract

BACKGROUND

Insomnia 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.

METHODS

Participants 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).

DISCUSSION

The 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.

摘要

背景

轻度认知障碍老年人的失眠症状给生活质量带来了损害,未治疗的失眠症风险增加,药物治疗失眠症的不良反应增加,这给公共健康带来了重大负担。为了应对目前针对轻度认知障碍老年人失眠症最有效的非药物治疗方法的局限性,我们正在进行一项随机试点研究,以测试一种简短的(4 周)、基于平板电脑的、个性化的、多组分行为睡眠干预(MBSI)治疗失眠症的方法,与睡眠教育对照组相比,在轻度认知障碍的老年人样本中。

方法

参与者将以 1:1 的比例随机分配到干预组或对照组。两组都将完成三次虚拟研究数据收集访问:基线、干预后 4 周和干预后 12 周随访。4 周干预的关键组成部分包括睡眠卫生教育、白天刺激有意义的活动和夜间促进放松疗法。我们将确定 MBSI 与睡眠教育相比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来探索干预影响睡眠和健康相关生活质量的机制。

结果

(无)。

讨论

该项目的研究结果将为未来更大规模的临床试验提供信息,并可能为轻度认知障碍的老年人提供一种新颖的创新方法,以实现更好的睡眠和健康相关的生活质量结果。

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