A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk: Design and methodology of a randomized clinical trial.
A non-pharmacological multi-modal therapy to improve sleep and cognition and reduce mild cognitive impairment risk: Design and methodology of a randomized clinical trial.
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一种改善睡眠和认知并降低轻度认知障碍风险的非药物多模式疗法：随机临床试验的设计和方法。
DOI：
10.1016/j.cct.2023.107275
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发表时间：
2023
影响因子：
2.2
通讯作者：
Buxton,OrfeuM
中科院分区：
文献类型：
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作者：
Emert,SarahE;Taylor,DanielJ;Gartenberg,Daniel;Schade,MargeauxM;Roberts,DanielM;Nagy,SamanthaM;Russell,Michael;Huskey,Alisa;Mueller,Melissa;Gamaldo,Alyssa;Buxton,OrfeuM
老年人睡眠不足的风险增加（例如，失眠）与各种慢性健康风险有关，包括阿尔茨海默病和相关痴呆症（ADRD）。非处方药会带来额外的风险，包括增加嗜睡和福尔斯，以及多种药物的风险。推荐的失眠症一线治疗是失眠症认知行为疗法（CBTi），但使用受限。远程保健是增加获得服务的途径之一，特别是对老年人而言，但迄今为止，远程保健通常仅限于简单的视频会议门户。虽然这些门户已被证明不劣于面对面治疗，但远程保健似乎可以得到显著改善。这项工作描述了一个协议，旨在评估是否临床医生-患者仪表板包括几个用户友好的功能（例如，来自流动设备的睡眠数据模式、指导性放松资源以及完成家庭CBTi实践的提醒）可以改善中老年人的CBTi结果（N= 100）。参与者被随机分配到通过6周一次的会议提供的三种远程医疗干预措施中的一种：（1）CBTi增强了临床医生-患者仪表板，智能手机应用程序和集成智能设备;（2）标准CBTi（即，活性对照物）;或（3）睡眠卫生教育（即，主动控制）。在筛选、研究前评价、基线、整个治疗期间和治疗后1周对所有参与者进行评估。主要结局是炎症严重程度指数。次要和探索性结局涵盖睡眠日记、actiwatch和Apple Watch评估的睡眠参数（例如，效率、持续时间、定时、可变性），心理社会相关性（例如，疲劳、抑郁、压力）、认知表现、治疗依从性以及神经变性和全身炎症生物标志物。
Aging populations are at increased risk of sleep deficiencies (e.g., insomnia) that are associated with a variety of chronic health risks, including Alzheimer's disease and related dementias (ADRD). Insomnia medications carry additional risk, including increased drowsiness and falls, as well as polypharmacy risks. The recommended first-line treatment for insomnia is cognitive behavioral therapy for insomnia (CBTi), but access is limited. Telehealth is one way to increase access, particularly for older adults, but to date telehealth has been typically limited to simple videoconferencing portals. While these portals have been shown to be non-inferior to in-person treatment, it is plausible that telehealth could be significantly improved. This work describes a protocol designed to evaluate whether a clinician-patient dashboard inclusive of several user-friendly features (e.g., patterns of sleep data from ambulatory devices, guided relaxation resources, and reminders to complete in-home CBTi practice) could improve CBTi outcomes for middle- to older-aged adults (N= 100). Participants were randomly assigned to one of three telehealth interventions delivered through 6-weekly sessions: (1) CBTi augmented with a clinician-patient dashboard, smartphone application, and integrated smart devices; (2) standard CBTi (i.e., active comparator); or (3) sleep hygiene education (i.e., active control). All participants were assessed at screening, pre-study evaluation, baseline, throughout treatment, and at 1-week post-treatment. The primary outcome is the Insomnia Severity Index. Secondary and exploratory outcomes span sleep diary, actiwatch and Apple watch assessed sleep parameters (e.g., efficiency, duration, timing, variability), psychosocial correlates (e.g., fatigue, depression, stress), cognitive performance, treatment adherence, and neurodegenerative and systemic inflammatory biomarkers.