Passive Foot Movement and Sleep-Disordered Breathing in Heart Failure

描述(由申请人提供)：睡眠障碍呼吸(SDB)在心力衰竭(HF)患者中很常见，并与发病率和死亡率增加有关。目前对SDB的治疗并没有显示出能提高存活率，而且常常有很高的不依从性，在SDB缓解方面缺乏疗效，和/或与疼痛相关。被动足部运动是指足部的节律性运动，不是自愿的，它可以增加通气量，但尚未在心力衰竭患者中进行检测。我们假设，与持续/双相正压相比，被动足部运动将降低SDB(呼吸暂停低通气指数[AHI])，对睡眠状态影响很小或几乎没有影响(睡眠中唤醒次数较少)、更好的睡眠(通过匹兹堡睡眠质量指数问卷测量)，以及更倾向于被动足部运动(CPAP/BiPAP-传统的SDB治疗方法)。采用单组、准实验、试验前后设计，我们将检查26名患有晚期心衰(左心室射血分数0.40，扩张性收缩功能障碍，年龄40-65岁，非急性心衰)和慢性阻塞性肺疾病(AHI和GT；5通过过夜多导睡眠监测)的受试者，他们将被随机分成在前半夜或后半夜在夜间多导睡眠监测期间进行被动足部运动。这项研究的具体目的是：1)检查SDB(如AHI所示)、血氧减饱和、二氧化碳水平和被动足部活动之间的关系；2)检查患有SDB的心衰患者夜间睡眠检查(多导睡眠图)中被动足部活动与睡眠阶段变化的关系；3)确定有SDB病史的心衰患者被动足部活动对主观报告睡眠质量的影响。本研究的目的是确定一种新的治疗方案--被动足部活动与心力衰竭患者的SDB之间的关系。如果被动足部活动减少SDB，并且心衰患者可以耐受，这种干预措施可能会改变临床实践，改善这一高危患者群体的预后。 公共卫生相关性：睡眠障碍呼吸在心力衰竭中很常见，并与发病率和死亡率的增加有关。目前对睡眠障碍呼吸的治疗并未显示出心力衰竭结果的改善，而且往往与高度不依从性、无效和/或疼痛风险增加有关。被动足部运动是足部的有节奏的运动，而不是自愿的，这会导致更多的通风。这是一种治疗睡眠障碍呼吸的创新选择，有可能有效地治疗心力衰竭患者，同时显著降低不良反应的风险。如果有效，被动的足部运动可能会对心力衰竭疾病的进展和存活率产生重要影响。

DESCRIPTION (provided by applicant): Sleep-disordered breathing (SDB) is common in heart failure (HF) patients and associated with increased morbidity and mortality. Current treatments for SDB have not been shown to improve survival and often have high non-compliance, lack of efficacy in SDB alleviation, and/or associated with pain. Passive foot movement, the rhythmic movement of feet without voluntary effort, is known to increase ventilation but has not been examined in HF patients. We hypothesize that passive foot movement will decrease SDB (decrease in Apnea-Hypopnea Index [AHI]) with little or no impact on sleep state (fewer arousals during sleep), better sleep (measured by the Pittsburgh Sleep Quality Index Questionnaire) and greater preference for passive foot movement compared to continuous/biphasic positive airway pressure (CPAP/BiPAP - traditional SDB treatment methods). Using a one-group, quasi-experimental, pre- and post-test design, we will examine 26 subjects with advanced HF (left ventricular ejection fraction < 0.40, dilated systolic dysfunction, not in acute HF, age 40-65 years) and SDB (AHI > 5 via overnight polysomnography in the previous 6 months) who will be randomized to undergo passive foot movement either during the first or last half of the night during overnight polysomnography. The specific aims for this study are to: 1) Examine the association between SDB (as indicated by AHI), blood oxygen desaturation, carbon dioxide blood levels and passive foot movement; 2) Examine the association between passive foot movement and changes in sleep stage during an overnight sleep study (polysomnography) in HF patients with SDB; 3) Determine the impact of passive foot movement on subjective reports of sleep quality in HF patients with a history of SDB. The objective is of this study is to determine the relationships between a novel treatment option, passive foot movement, and SDB in HF patients. If passive foot movement decreases SDB and is tolerable to persons with HF, this intervention could have change clinical practice and improve outcomes in this high risk patient population. PUBLIC HEALTH RELEVANCE: Sleep-disordered breathing is common in heart failure and is associated with increased morbidity and mortality. Current treatments for sleep-disordered breathing have not demonstrated improvement in heart failure outcomes and often are associated with high non-compliance, ineffectiveness, and/or increased risk for pain. Passive foot movement is the rhythmic movement of the feet without voluntary effort, which results in increased ventilation. It is an innovative treatment option for sleep-disordered breathing which has the potential to effectively treat heart failure patients with dramatically decreased risk of adverse effects. If effective, passive foot movement could have important impact on heart failure disease progression and survival.