OSA, Sleepiness, and Activity in Diabetes Management

描述（由申请人提供）：阻塞性睡眠呼吸暂停（OSA）是一种严重的疾病，其特征是咽部气道的间歇性阻塞，伴有气流停止或减少。未经治疗的OSA每天24小时都有负面影响，扰乱夜间睡眠，导致白天过度嗜睡，干扰功能。最近的研究表明，OSA和2型糖尿病（T2 DM）不仅共存，但OSA可能会对葡萄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严重程度或白天嗜睡可能会阻碍T2 DM患者参与体力活动。本初步/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发展，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受试者与接受假CPAP治疗的受试者相比的体力活动。次要目的是探索：1）OSA严重程度、日间嗜睡和体力活动与基线血糖变异性的相互关系; 2）与接受假CPAP的受试者相比，用CPAP治疗的受试者中葡萄糖变异性的平均治疗前后变化，和3）治疗前后体重、饮食，与接受假CPAP的受试者相比，接受CPAP治疗的受试者的残余嗜睡和情绪。该研究的主要终点是身体活动，将通过Bodymedia SenseWear Pro Armband（R）进行测量，以确定活动计数。血糖变异性的终点将由美敦力动态血糖监测系统（CGMS）测量。将通过插入受试者CPAP机器中的智能卡（R）测量CPAP依从性。我们将随机分配至CPAP或假CPAP组的受试者样本限制为治疗前睡眠时间充足（> 6小时）、患有中度或重度OSA和EDS的受试者，以便为该初步研究提供更均匀、受影响更深的样本。关于OSA和EDS对葡萄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善行为干预的发展。此外，这项研究还包括饮食和情绪的测量，以开始阐明OSA和EDS对糖尿病管理的可能影响。R21奖的研究结果将用于开发和测试一项完全有效的临床试验，该试验可以测试CPAP治疗对T2 DM患者体力活动的有效性，以改善糖尿病结局。公共卫生相关性：日常体力活动对2型糖尿病患者实现血糖控制很重要。本研究的目的是探讨阻塞性睡眠呼吸暂停及其日间症状，过度嗜睡，是否是身体活动的障碍。我们将研究在2型糖尿病患者中使用持续气道正压通气治疗阻塞性睡眠呼吸暂停是否会增加体力活动。

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.