A randomized trial of bariatric surgery for the treatment of sleep apnea

一项减肥手术治疗睡眠呼吸暂停的随机试验

• 批准号: 8264973
• 负责人: Sanjay R Patel
• 金额: $ 94.74万
• 依托单位: BRIGHAM AND WOMEN'S HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-08-14 至 2013-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8264973
• 关键词: Address; Adherence; Adverse event; Air; Apnea; Bariatrics; Biochemical; Biological Markers; Blood Pressure; Blood Vessels; Body Weight decreased; Body mass index; Breathing; Cardiovascular Diseases; Caring; Case Series; Characteristics; Clinic; Clinical; Comorbidity; Congestive Heart Failure; Continuous Positive Airway Pressure; Controlled Environment; Cost Effectiveness Analysis; Cost-Benefit Analysis; Counseling; Data; Diabetes Mellitus; Effectiveness; Ensure; Environment; Equipoise; Event; Excessive Daytime Sleepiness; Exposure to; Future; Genetic Crossing Over; Goals; Healthcare; Home environment; Hour; Hypertension; Hypoxemia; Individual; Inflammation; Insulin Resistance; Intervention; Length; Life; Lipids; Literature; Masks; Measures; Medical; Methods; Modification; Monitor; Moods; Morbid Obesity; Newly Diagnosed; Nose; Obesity; Obstructive Sleep Apnea; Operative Surgical Procedures; Outcome; Outcome Measure; Oxidative Stress; Participant; Patient Outcomes Assessments; Patient Self-Report; Patients; Pharyngeal structure; Phase III Clinical Trials; Physicians; Pilot Projects; Placebo Effect; Procedures; Protocols documentation; Quality of life; Randomized; Recruitment Activity; Recurrence; Relative (related person); Reporting; Research Design; Residual Tumors; Residual state; Resources; Risk; Role; Safety; Sample Size; Severities; Sleep; Sleep Apnea Syndromes; Stroke; Structure; Subgroup; Symptoms; Testing; Weight; arm; arterial stiffness; bariatric surgery; base; clinical research site; common treatment; comparative effectiveness; comparative efficacy; compliance behavior; cost; design; evidence base; follow-up; functional disability; health care service utilization; improved; inclusion criteria; indexing; mortality; nCPAP Ventilation; novel strategies; pressure; primary outcome; programs; public health relevance; randomized trial; respiratory; secondary outcome; standard of care; success; treatment response; treatment strategy; trial comparing

DESCRIPTION (provided by applicant): Obstructive sleep apnea (OSA) is one of the most common complications of obesity, resulting in excessive sleepiness and daytime functional impairment. In addition, the recurrent exposure to intermittent hypoxemia appears to act synergistically with obesity in predisposing to hypertension, insulin resistance, diabetes, cardiovascular disease, and stroke. The current first line treatment for moderate to severe OSA, nasal continuous positive airway pressure (CPAP) is extremely effective but is often not well tolerated, leading to low adherence rates in many patients. Bariatric surgery has been approved as treatment for OSA in patients with co-morbid obesity and in small case series, appears to produce substantial improvements. However, no trials directly comparing bariatric procedures with standard CPAP treatment yet exist to guide clinicians and patients in choosing the most appropriate first line treatment. We propose to conduct a pilot study to address the feasibility and safety, and estimate the effect sizes for a subsequent Phase 3 trial. We will recruit 80 patients with severe OSA and morbid obesity (body mass index, BMI, of 35-40 kg/m2) from two large clinical sleep programs that together care for a wide spectrum and demographically diverse group of OSA patients. After establishing patient and physician equipoise, subjects will be randomized to a trial of CPAP or laparoscopic gastric banding as first line treatment for OSA. The primary outcome measures will be improvement in OSA severity under both ideal and real life conditions (i.e., in the OSA arm, while using CPAP in a controlled environment vs. while using prescribed therapy in the usual home environment, respectively), which will allow for assessments of both comparative efficacy and effectiveness. Outcomes will be assessed at 9 months to quantify the early effectiveness of each treatment strategy as well as to demonstrate clinical equipoise in conducting a future larger long term trial using these two arms. Further follow-up will occur at 18 months in a subset of 40 patients to determine effect sizes for the subsequent study at a point where the bariatric arm has neared a plateau in weight. Secondary outcomes will include patient-related outcomes including sleepiness, quality of life, and an index of health service utilization. In addition, changes in biomarkers related to inflammation, insulin resistance, lipids, blood pressure, and arterial stiffness will be assessed in each group, and in relationship to changes in BMI and OSA, to identify promising outcome measures for future trials. Incurred costs will be collected in all subjects in order to establish the parameters needed for a cost effectiveness analysis. This pilot study will represent the first controlled comparison of medical and surgical treatments for OSA and in addition, will provide the necessary data to develop the optimal study design for a subsequent long term multi-center comparative effectiveness study to better understand the potential role that bariatric surgery may offer in the management of OSA. PUBLIC HEALTH RELEVANCE: Sleep apnea, which involves breathing stoppages during sleep, is one of the most common complications of obesity. Currently the most common treatment for sleep apnea is continuous positive airway pressure (CPAP) which consists of a mask applied to the nose and a blower that blows air under pressure. While CPAP is effective at keeping the throat open, it is often uncomfortable and so difficult for many patients to use on a regular basis. Bariatric or weight loss surgery has been shown to be effective at producing weight loss and because of this, may also be effective at curing sleep apnea. In this study, we will conduct a trial comparing the ability of CPAP and bariatric surgery to treat sleep apnea in patients who have severe sleep apnea and morbid obesity.

描述（由申请人提供）：阻塞性睡眠呼吸暂停（OSA）是肥胖最常见的并发症之一，导致过度嗜睡和白天功能障碍。此外，反复出现间歇性低氧血症似乎与肥胖协同作用，易患高血压、胰岛素抵抗、糖尿病、心血管疾病和中风。目前，经鼻持续气道正压通气 (CPAP) 是治疗中度至重度 OSA 的一线治疗方法，非常有效，但往往耐受性不佳，导致许多患者的依从率较低。减肥手术已被批准作为患有肥胖症的患者的 OSA 治疗方法，并且在小病例系列中，似乎产生了实质性的改善。然而，尚无直接比较减肥手术与标准 CPAP 治疗的试验来指导临床医生和患者选择最合适的一线治疗。我们建议进行一项试点研究来解决可行性和安全性，并估计后续第 3 阶段试验的效果大小。我们将从两个大型临床睡眠项目中招募 80 名患有严重 OSA 和病态肥胖（体重指数 BMI 为 35-40 kg/m2）的患者，这两个项目共同照顾广泛且人口多样化的 OSA 患者群体。在建立患者和医生平衡后，受试者将被随机分配接受 CPAP 或腹腔镜胃束带术作为 OSA 一线治疗的试验。主要结果指标是在理想和现实生活条件下（即，在 OSA 组中，分别在受控环境中使用 CPAP 与在通常家庭环境中使用处方治疗时）OSA 严重程度的改善，这将允许评估比较疗效和有效性。将在 9 个月时评估结果，以量化每种治疗策略的早期有效性，并证明在使用这两种治疗方法进行未来更大规模的长期试验时的临床平衡。进一步的随访将在 18 个月时对 40 名患者进行，以确定减肥组体重接近稳定状态时后续研究的效果大小。次要结果将包括与患者相关的结果，包括嗜睡、生活质量和卫生服务利用指数。此外，还将评估每组中与炎症、胰岛素抵抗、血脂、血压和动脉僵硬度相关的生物标志物的变化，以及与 BMI 和 OSA 变化的关系，以确定未来试验的有希望的结果指标。将收集所有科目所发生的成本，以便建立成本效益分析所需的参数。这项试点研究将代表 OSA 药物治疗和手术治疗的首次对照比较，此外，还将提供必要的数据，为后续的长期多中心比较有效性研究制定最佳研究设计，以更好地了解减肥手术在 OSA 治疗中可能发挥的潜在作用。 公共卫生相关性：睡眠呼吸暂停涉及睡眠期间呼吸停止，是肥胖最常见的并发症之一。目前，睡眠呼吸暂停最常见的治疗方法是持续气道正压通气 (CPAP)，它由戴在鼻子上的面罩和在压力下吹气的吹风机组成。虽然 CPAP 可以有效地保持喉咙畅通，但它通常会让人感到不舒服，并且对于许多患者来说很难定期使用。减肥或减肥手术已被证明可以有效减轻体重，因此也可能有效治疗睡眠呼吸暂停。在这项研究中，我们将进行一项试验，比较 CPAP 和减肥手术治疗患有严重睡眠呼吸暂停和病态肥胖的患者的睡眠呼吸暂停的能力。