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: 9980894
• 负责人: Esra Tasali
• 金额: $ 72.29万
• 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/9980894
• 关键词: Address; Adherence; Advisory Committees; Beta Cell; Blood Pressure; Body Weight decreased; Cardiovascular Diseases; Cardiovascular Physiology; Cardiovascular system; Caring; Cell physiology; Clinical; Clinical Trials; Continuous Positive Airway Pressure; Diabetes Mellitus; Diagnosis; Diastolic blood pressure; Diet; Disease; Environment; Fasting; Feedback; General Population; Glucose; Goals; Health; High Density Lipoprotein Cholesterol; High Prevalence; Hour; Incidence; Individual; Intervention; Knowledge; LDL Cholesterol Lipoproteins; Laboratories; Level of Evidence; Life; Life Style; Life Style Modification; Link; Lipids; Metabolic; Methods; Modeling; Monitor; OGTT; Obesity; Obstructive Sleep Apnea; Outcome; Overweight; Patients; Prediabetes syndrome; Preventive Health Services; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Sampling; Sleep Apnea Syndromes; Specialist; Technology; Testing; Time; Triglycerides; Weight; Work; adult obesity; behavior change; blood lipid; cardiometabolic risk; cardiometabolism; clinical decision-making; clinically relevant; cost effective; diet and exercise; evidence base; glucose metabolism; high risk; high risk population; improved; insulin sensitivity; lifestyle intervention; novel; prevent; primary outcome; routine screening; screening; smartphone Application; standard of care; success; treatment adherence

PROJECT SUMMARY 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.

项目概要 强化生活方式干预（饮食和运动）是糖尿病前期的主要治疗方法。尽管他们的 功效，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 并减少其心血管并发症。睡眠呼吸暂停是一种可治疗的疾病，已被广泛证实 与心脏代谢疾病有关。建议持续气道正压通气 (CPAP) 为被诊断患有睡眠呼吸暂停的患者提供治疗。然而，大约80%的患者患有睡眠呼吸暂停 仍未确诊，因此不接受 CPAP 治疗。迄今为止，还没有一项临床试验调查 生活方式干预对糖尿病前期心脏代谢风险的影响，评估睡眠呼吸暂停或包括 干预治疗睡眠呼吸暂停。尽管糖尿病前期患者睡眠呼吸暂停的患病率很高，但绝大多数患者 由于缺乏高水平证据表明治疗具体改善，患者未被诊断 糖尿病和心血管结局，这是护理专家的主要治疗目标 高危人群。此外，由于严格且有力的随机试验证据不足 对照试验中，美国预防健康服务工作组建议不要进行一般筛查 睡眠呼吸暂停。值得注意的是，没有一项随机对照 CPAP 试验评估心脏代谢结果 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，并解决有针对性的、新颖的和临床相关的问题 问题。我们将首次确定将 CPAP 治疗添加到生活方式干预中是否可以改善 糖尿病前期的心脏代谢结果超出了仅通过生活方式（即当前护理标准）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 或生活方式加 CPAP。我们将在基线和之后获得相同的代谢和心血管评估 6个月的干预。我们的具体目标是检验以下假设：综合干预措施（生活方式加 CPAP）将导致血糖水平、胰岛素敏感性和 β 细胞功能的更大改善（目标 1），以及 与单独的生活方式相比，血压和血脂状况 (Aim2)。最大限度地提高干预成功率 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，这将允许对个人的习惯进行实时、客观的监测 环境并提供及时反馈以实现目标。迄今为止，之前还没有研究实施过这样的方法 对糖尿病前期和睡眠呼吸暂停患者进行技术支持的干预。 CPAP 的另一个好处 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 CPAP 处方者定期实施强化生活方式改变，作为治疗的一部分 睡眠呼吸暂停治疗方案。我们的试验将解决随机临床试验在影响方面的主要差距 睡眠呼吸暂停治疗对葡萄糖代谢的影响，从而为基于证据的临床决策提供信息。