OSA, Sleepiness, and Activity in Diabetes Management

描述(申请人提供)：阻塞性睡眠呼吸暂停(OSA)是一种严重的疾病，以咽部呼吸道的间歇性阻塞为特征，并伴有气流停止或减少。未经治疗的OSA一天24小时都会产生负面影响，扰乱夜间睡眠，并导致白天过度嗜睡，从而干扰功能。最近的研究表明，OSA和2型糖尿病(T2 DM)不仅共存，而且OSA可能会对血糖稳态产生不利影响。虽然体力活动被认为对T2 DM患者有益，但OSA的严重性或日间嗜睡可能会阻碍T2 DM患者参与体力活动。这项试点/可行性研究的主要目的是获得初步数据，以促进进一步的假设开发，并增强进行双盲、随机、安慰剂对照研究的可行性，以检查接受CPAP治疗的T2 DM和OSA患者与接受Sham-CPAP治疗的患者的体力活动。第二个目的是探索：1)阻塞性睡眠呼吸暂停严重程度、日间嗜睡和体力活动对基线血糖变异性的相互关系；2)接受CPAP治疗的受试者与接受假CPAP治疗的受试者相比，治疗前血糖变异性的平均变化；以及3)接受CPAP治疗的受试者与接受假CPAP治疗的受试者相比，治疗前后体重、饮食、残余嗜睡和情绪的变化。这项研究的主要终点--体力活动将由BodyMedia SenseWear Pro臂章(R)测量，以确定活动次数。血糖变异性的终点将由美敦力连续血糖监测系统(CGMS)测量。对CPAP的遵守将通过插入受试者CPAP机器中的智能卡(R)来衡量。我们将把随机分为CPAP组或假CPAP组的受试者限制为在治疗前睡眠时间充足(6小时)、患有中度或重度阻塞性睡眠呼吸暂停(OSA)以及患有EDS的受试者，以便在这项先导研究中有一个更同质、受影响更深的样本。关于OSA和EDS对血糖变异性影响的拟议研究将产生的信息有可能导致糖尿病患者改进行为干预的发展。此外，这项研究包含了饮食和情绪的测量，以开始阐明OSA和EDS对糖尿病管理的可能影响。这项R21奖项的研究结果将被用于开发和测试一项全功率临床试验，该试验可以测试CPAP治疗对T2 DM患者体力活动的疗效，目的是改善糖尿病结果。公共卫生相关性：日常体力活动对于实现2型糖尿病患者的血糖控制很重要。这项研究的目的是探索阻塞性睡眠呼吸暂停症及其白天的症状--过度嗜睡--是否会成为体力活动的障碍。我们将研究持续气道正压治疗阻塞性睡眠呼吸暂停是否能增加2型糖尿病患者的体力活动。

DESCRIPTION (provided by applicant): Obstructive sleep apnea (OSA) is a serious disorder characterized by episodic obstruction of the pharyngeal airway accompanied by cessation or reduction in airflow. Untreated OSA has a negative impact 24 hours a day, disrupting nighttime sleep and causing excessive daytime sleepiness that interferes with functioning. Recent studies suggest that OSA and type 2 diabetes (T2DM) not only co-exist but that OSA may adversely affect glucose homeostasis. While physical activity is recognized as beneficial to persons with T2DM, OSA severity or daytime sleepiness may act to hinder persons with T2DM from participating in physical activity. The primary aim of this pilot/feasibility study is to obtain preliminary data to facilitate further hypothesis development and enhance the feasibility of conducting a double blind, randomized, placebo-controlled study to examine physical activity in subjects with T2DM and OSA who are treated with CPAP compared to subjects on sham-CPAP. The secondary aims are to explore: 1) the interrelationships of OSA severity, daytime sleepiness, and physical activity on glucose variability at baseline; 2) average pre-post therapy changes in glucose variability in subjects treated with CPAP compared to subjects receiving sham-CPAP, and 3) pre to post therapy changes in weight, diet, residual sleepiness and mood in subjects treated with CPAP compared to subjects receiving sham-CPAP. The primary endpoint of the study, physical activity, will be measured by the Bodymedia SenseWear Pro Armband(R) to determine activity counts. The endpoint for glucose variability will be measured by the Medtronic Continuous Glucose Monitoring System (CGMS). Adherence to CPAP will be measured by a Smart Card(R) inserted in subjects' CPAP machines. We will limit the sample of subjects who are randomized to CPAP or sham-CPAP to persons with an adequate sleep duration pre-treatment (> 6 hours), with moderate or severe OSA and with EDS to have a more homogenous, profoundly affected sample for this pilot study. The information that will result from the proposed study on of the effect of OSA and EDS on glucose variability has the potential to lead to the development of improved behavioral interventions in persons with diabetes. In addition, this study contains measures of diet and mood to begin to elucidate the possible effects of OSA and EDS on diabetes management. The study results from this R21 award will be used to inform the development and testing of a fully powered clinical trial that can test the efficacy of CPAP treatment on physical activity in persons with T2DM with the goal of improving diabetes outcomes. PUBLIC HEALTH RELEVANCE: Daily physical activity is important to achieve glucose control in persons with type 2 diabetes. The purpose of this study is to explore if obstructive sleep apnea and its daytime symptom, excessive sleepiness, act as barriers to physical activity. We will examine if treatment of obstructive sleep apnea with continuous positive airway pressure results in increased physical activity in persons with type 2 diabetes.