Passive Foot Movement and Sleep-Disordered Breathing in Heart Failure

描述（由申请人提供）：睡眠呼吸障碍（SDB）在心力衰竭（HF）患者中很常见，并与发病率和死亡率增加相关。目前的SDB治疗尚未显示出改善生存率，并且通常具有高不依从性，在SDB缓解中缺乏功效，和/或与疼痛相关。被动的足部运动，即无意识的足部节律性运动，已知可增加通气，但尚未在HF患者中进行检查。我们假设被动足部运动将降低SDB（呼吸暂停低通气指数[AHI]降低），对睡眠状态（睡眠期间唤醒次数较少）影响很小或没有影响，与连续/双相气道正压通气（CPAP/BiPAP -传统SDB治疗方法）相比，睡眠质量更好（通过匹兹堡睡眠质量指数问卷测量），更倾向于被动足部运动。采用单组、准实验、前测和后测设计，我们将检查26名晚期HF受试者（左心室射血分数< 0.40，扩张性收缩功能障碍，不存在于急性HF中，年龄40-65岁）和SDB（过去6个月通过夜间多导睡眠图AHI > 5）在夜间多导睡眠描记期间，这些患者将被随机分配在前半夜或后半夜进行被动足部运动。本研究的具体目的是：1）考察SDB与（如AHI所示）、血氧饱和度下降、二氧化碳血液水平和被动足部运动; 2）检查夜间睡眠研究期间被动足部运动与睡眠阶段变化之间的关联（多导睡眠图）; 3）确定被动足部运动对具有SDB病史的HF患者的睡眠质量的主观报告的影响。 本研究的目的是确定一种新的治疗选择，被动足部运动，和SDB在HF患者之间的关系。如果被动足部运动降低SDB并且HF患者可以耐受，则该干预可能会改变临床实践并改善该高风险患者人群的结局。 公共卫生相关性：睡眠呼吸障碍在心力衰竭中很常见，并与发病率和死亡率增加相关。目前对睡眠呼吸障碍的治疗尚未显示出心力衰竭结局的改善，并且通常与高不依从性、无效性和/或疼痛风险增加相关。被动足部运动是足部的有节奏的运动，没有自愿的努力，这导致增加通风。这是一种治疗睡眠呼吸障碍的创新选择，有可能有效地治疗心力衰竭患者，并显著降低不良反应的风险。如果有效，被动足部运动可能对心力衰竭疾病进展和生存率产生重要影响。

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.