Technology-Supported Treatment of Sleep Apnea in Prediabetes

糖尿病前期睡眠呼吸暂停的技术支持治疗

• 批准号: 10886362
• 负责人: Esra Tasali
• 金额: $ 28万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10886362
• 关键词: Address; Adherence; Advisory Committees; Beta Cell; Blood Pressure; Cardiometabolic Disease; Cardiovascular system; Caring; Cell physiology; Clinical Trials; Continuous Positive Airway Pressure; Diabetes Mellitus; Diagnosis; Disease; Environment; Feedback; Glucose; Goals; High Prevalence; Incidence; Individual; Intervention; Knowledge; Level of Evidence; Life Style; Life Style Modification; Metabolic; Monitor; Outcome; Overweight; Parents; Patients; Persons; Prediabetes syndrome; Preventive Health Services; Randomized; Randomized, Controlled Trials; Recommendation; Sleep Apnea Syndromes; Specialist; Technology; Testing; Time; adult obesity; blood lipid; cardiometabolic risk; cardiometabolism; clinical decision-making; clinically relevant; cost effective; diet and exercise; evidence base; glucose metabolism; high risk population; improved; insulin sensitivity; lifestyle intervention; novel; prevent; randomized, clinical trials; routine screening; screening; standard of care; success

PROJECT SUMMARY (from parent trial) Intensive lifestyle interventions (diet and exercise) are the mainstay of treatment in prediabetes. Despite their efficacy, diabetes incidence is rising, and thus there is a critical need for additional strategies to prevent diabetes and to reduce its cardiovascular complications. Sleep apnea is a treatable disorder that has been strongly associated with cardiometabolic disease. Continuous positive airway pressure (CPAP) is the recommended treatment for those who are diagnosed with sleep apnea. However, about 80% of patients who have sleep apnea remain undiagnosed, and thus not receive CPAP treatment. To date, not a single clinical trial investigating the effects of lifestyle interventions on cardiometabolic risk in prediabetes assessed for sleep apnea or included an intervention to treat sleep apnea. Despite high prevalence of sleep apnea in prediabetes, the vast majority of patients are not diagnosed due to lack of high level evidence to indicate that treatment specifically improves diabetes and cardiovascular outcomes, which are the primary treatment objectives of specialists caring for this high-risk population. Moreover, due to insufficient evidence from rigorous and well-powered randomized controlled trials, the U.S. Preventive Health Services Task Force recommended against general screening for sleep apnea. Notably, not a single randomized controlled CPAP trial assessing cardiometabolic outcomes utilized a technology-supported intervention to promote adherence, a key limitation in prior studies. Our proposed randomized clinical trial will fill these critical knowledge gaps and address a focused, novel and clinically relevant question. We will determine, for the first time, whether adding CPAP treatment to a lifestyle intervention improves cardiometabolic outcomes beyond that achieved with lifestyle alone (i.e. current standard of care) in prediabetes. Overweight and obese adults who have prediabetes and sleep apnea will be randomly assigned to lifestyle alone or lifestyle plus CPAP. We will obtain the same metabolic and cardiovascular assessments at baseline and after 6-months of intervention. Our specific aims are to test the hypothesis that a combined intervention (lifestyle plus CPAP) will lead to greater improvements in glucose levels, insulin sensitivity and beta cell function (Aim 1), and blood pressure and lipid profile (Aim2), as compared to lifestyle alone. To maximize intervention success and minimize subject burden, we propose a highly efficient, cost effective technology-supported approach for lifestyle intervention and CPAP treatment, which will allow real-time, objective monitoring of individuals in their habitual environment and delivering timely feedback to attain goals. To date, no prior study has implemented such a technology-supported intervention in people with prediabetes and sleep apnea. An added benefit of CPAP on cardiometabolic outcomes will strongly support routine screening for and treatment of sleep apnea in prediabetes and will encourage those prescribing CPAP to routinely implement intensive lifestyle modifications as part of treatment package for sleep apnea. Our trial will address a major gap in randomized clinical trials on the impact of sleep apnea treatment on glucose metabolism, and thus inform evidence-based clinical decision making.

项目总结（来自母试验） 强化生活方式干预（饮食和运动）是糖尿病前期治疗的主要手段。尽管他们 有效性，糖尿病发病率正在上升，因此迫切需要额外的策略来预防糖尿病 并减少心血管并发症。睡眠呼吸暂停是一种可治疗的疾病， 与心脏代谢疾病有关。持续气道正压通气（CPAP）是推荐的 睡眠呼吸暂停综合征是什么？然而，大约80%的睡眠呼吸暂停患者 未确诊，因此未接受CPAP治疗。到目前为止，还没有一项临床试验研究 生活方式干预对糖尿病前期患者心脏代谢风险的影响， 治疗睡眠呼吸暂停的方法尽管糖尿病前期睡眠呼吸暂停的患病率很高， 由于缺乏高水平的证据表明治疗能明显改善， 糖尿病和心血管结局，这是专家的主要治疗目标， 高危人群。此外，由于来自严格和有力的随机对照试验的证据不足， 对照试验，美国预防卫生服务工作组建议对一般筛查 睡眠呼吸暂停值得注意的是，没有一项评估心脏代谢结局的随机对照CPAP试验， 利用技术支持的干预措施来促进依从性，这是先前研究的一个关键限制。我们提出的 随机临床试验将填补这些关键的知识空白，并解决一个重点突出，新颖和临床相关 问题我们将首次确定在生活方式干预中加入CPAP治疗是否能改善 在前驱糖尿病患者中，心脏代谢结局超出了仅采用生活方式（即当前标准治疗）所实现的结果。 患有糖尿病前期和睡眠呼吸暂停的超重和肥胖成年人将被随机分配到单独的生活方式 或者生活方式加CPAP我们将在基线和治疗后获得相同的代谢和心血管评估结果。 6-几个月的干预。我们的具体目标是检验一个假设，即联合干预（生活方式加 CPAP）将导致葡萄糖水平、胰岛素敏感性和β细胞功能的更大改善（目标1）， 血压和血脂谱（Aim2），与单独的生活方式相比。为了最大限度地提高干预成功率， 为了最大限度地减少受试者负担，我们提出了一种高效，具有成本效益的技术支持的生活方式方法 干预和CPAP治疗，这将允许实时，客观地监测个人在他们的习惯 环境和提供及时的反馈，以实现目标。到目前为止，没有先前的研究已经实施了这样的一个 糖尿病前期和睡眠呼吸暂停综合征患者的技术支持干预。CPAP的另一个好处是 心脏代谢结果将有力支持糖尿病前期睡眠呼吸暂停的常规筛查和治疗 并将鼓励那些开CPAP处方的人定期实施强化的生活方式改变， 睡眠呼吸暂停综合症的治疗包。我们的试验将解决随机临床试验中的一个主要空白， 睡眠呼吸暂停治疗对葡萄糖代谢的影响，从而为循证临床决策提供信息。