A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial.
A timed activity protocol to address sleep-wake disorders in home dwelling persons living with dementia: the healthy patterns clinical trial.
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DOI：
10.1186/s12877-021-02397-2
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发表时间：
2021-08-03
期刊：
影响因子：
4.1
通讯作者：
Huang L
中科院分区：
文献类型：
--
作者：
Hodgson NA;Gooneratne N;Perez A;Talwar S;Huang L
睡眠-觉醒障碍发生在大多数患有痴呆症的人中，包括下午晚些时候或晚上的躁动，不规则的睡眠-觉醒节律，如白天嗜睡，频繁的夜间觉醒和睡眠效率低下。睡眠-觉醒障碍给家庭照顾者带来了巨大的负担，是造成痛苦、生活质量差和机构化的主要原因。通过使用光和活动来调节睡眠-觉醒周期已被证明可以改变核心时钟过程，并表明在战略时间提供的认知，身体和基于感觉的活动的组合可能是减少睡眠-觉醒障碍的有效机制。健康模式干预是一种旨在改善睡眠-觉醒障碍和生活质量的家庭活动干预，目前正在进行一项确定性的III期疗效试验，采用随机两组平行设计，共有200名痴呆症患者及其护理人员（二人组）。这个为期一个月的家庭干预的具体组成部分涉及4次家访，包括：1）评估个人的功能状态和兴趣; 2）教育护理人员了解环境线索，以促进活动和睡眠; 3）根据全天的昼夜节律需求，培训护理人员使用定时的上午，下午和晚上活动。关注的患者结局是生活质量、通过客观和主观指标评估的睡眠测量，包括体动记录、主观睡眠质量和神经精神症状的存在。关心的护理结果是生活质量、负担、使用活动的信心和睡眠中断。收集皮质醇和褪黑激素的唾液测量值以评估潜在的干预机制。正在进行的研究的结果将提供关于基于昼夜需求的定时活动参与的影响的基本新知识，以及定时干预的机制，这可以导致一种结构化的，可复制的治疗方案，用于日益增长的痴呆症患者。Clinicaltrials.gov #NCT 03682185，网址：https：//clinicaltrials.gov/;临床试验注册日期：2018年9月24日。
Sleep-wake disorders occur in most persons living with dementia and include late afternoon or evening agitation, irregular sleep-wake rhythms such as daytime hypersomnia, frequent night awakenings, and poor sleep efficiency. Sleep-wake disorders pose a great burden to family caregivers, and are the principal causes of distress, poor quality of life, and institutionalization. Regulating the sleep-wake cycle through the use of light and activity has been shown to alter core clock processes and suggests that a combination of cognitive, physical, and sensory-based activities, delivered at strategic times, may be an effective mechanism through which to reduce sleep-wake disorders. A definitive Phase III efficacy trial of the Healthy Patterns intervention, a home-based activity intervention designed to improve sleep-wake disorders and quality of life, is being conducted using a randomized two-group parallel design of 200 people living with dementia and their caregivers (dyads). Specific components of this one-month, home-based intervention involve 4 in-home visits and includes: 1) assessing individuals’ functional status and interests; 2) educating caregivers on environmental cues to promote activity and sleep; and 3) training caregivers in using timed morning, afternoon, and evening activities based on circadian needs across the day. The patient focused outcomes of interest are quality of life, measures of sleep assessed by objective and subjective indicators including actigraphy, subjective sleep quality, and the presence of neuropsychiatric symptoms. Caregiver outcomes of interest are quality of life, burden, confidence using activities, and sleep disruption. Salivary measures of cortisol and melatonin are collected to assess potential intervention mechanisms. The results from the ongoing study will provide fundamental new knowledge regarding the effects of timing activity participation based on diurnal needs and the mechanisms underlying timed interventions which can lead to a structured, replicable treatment protocol for use with this growing population of persons living with dementia. Clinicaltrials.gov # NCT03682185 at https://clinicaltrials.gov/; Date of clinical trial registration: 24 September 2018.
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