OSA, Sleepiness, and Activity in Diabetes Management

OSA、嗜睡和糖尿病管理中的活动

• 批准号: 7653328
• 负责人: Eileen R Chasens
• 金额: $ 22.73万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-04-01 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7653328
• 关键词: Adherence; Affect; Apnea; Area Under Curve; Arousal; Behavior Therapy; Breathing; Caring; Central obesity; Classification; Clinical Trials; Cognition; Communities; Continuous Positive Airway Pressure; Data; Development; Devices; Diabetes Mellitus; Diet; Disease; Double-Blind Method; Ensure; Epidemiologic Studies; Epidemiology; Evaluation; Excessive Daytime Sleepiness; Exploratory/Developmental Grant for Diagnostic Cancer Imaging; Feasibility Studies; General Population; Glucose; Goals; Hour; Individual; International; Intervention; Lead; Link; Measures; Moods; Non-Insulin-Dependent Diabetes Mellitus; Obstruction; Obstructive Sleep Apnea; Outcome; Oxidative Stress; Patient Self-Report; Patients; Persons; Physical activity; Pilot Projects; Population; Prevalence; Prevention; Randomized; Research; Research Personnel; Residual state; Sampling; Self Management; Severities; Sleep; Sleep Apnea Syndromes; Smart Card; Symptoms; System; Testing; Weight; Woman; base; blood glucose regulation; cardiovascular risk factor; diabetes management; effective therapy; efficacy testing; functional status; glucose monitor; improved; indexing; men; mortality; neurobehavior; primary outcome; public health relevance; randomized placebo controlled trial

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.

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，其特征是咽部气道间歇性阻塞，并伴有气流停止或减少。未经治疗的 OSA 每天 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，从而影响功能。最近的研究表明，OSA 和 2 型糖尿病 (T2DM) 不仅共存，而且 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 T2DM 患者有益，但 OSA 严重程度或白天嗜睡可能会阻碍 T2DM 患者参加体力活动。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发展，并提高进行双盲、随机、安慰剂对照研究的可行性，以检查接受 CPAP 治疗的 T2DM 和 OSA 受试者与假 CPAP 受试者的身体活动情况。次要目标是探索：1）OSA 严重程度、白天嗜睡和体力活动与基线血糖变异性之间的相互关系； 2) 与接受假 CPAP 治疗的受试者相比，接受 CPAP 治疗的受试者治疗前血糖变异性的平均变化，以及 3) 与接受假 CPAP 治疗的受试者相比，接受 CPAP 治疗的受试者治疗前后体重、饮食、残余睡意和情绪的变化。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通过美敦力连续血糖监测系统 (CGMS) 进行测量。对 CPAP 的遵守情况将通过插入受试者 CPAP 机器中的智能卡 (R) 来测量。我们将随机接受 CPAP 或假 CPAP 的受试者样本限制为治疗前有足够睡眠时间（> 6 小时）、患有中度或重度 OSA 以及患有 EDS 的人，以便为该试点研究提供更均匀、受影响更严重的样本。关于 OSA 和 EDS 对血糖变异性影响的拟议研究所产生的信息有可能导致糖尿病患者行为干预措施的发展。此外，这项研究还包含饮食和情绪测量，以开始阐明 OSA 和 EDS 对糖尿病管理的可能影响。 R21 奖项的研究结果将用于为一项功能齐全的临床试验的开发和测试提供信息，该临床试验可以测试 CPAP 治疗对 T2DM 患者体力活动的功效，以改善糖尿病结局。公共卫生相关性：日常体力活动对于 2 型糖尿病患者实现血糖控制非常重要。本研究的目的是探讨阻塞性睡眠呼吸暂停及其白天症状（过度嗜睡）是否会阻碍身体活动。我们将检查持续气道正压治疗阻塞性睡眠呼吸暂停是否会导致 2 型糖尿病患者体力活动增加。