APPLES: Apnea Positive Pressure Long-Term Efficacy Study

APPLES：呼吸暂停正压长期疗效研究

• 批准号: 6665492
• 负责人: WILLIAM C DEMENT
• 金额: $ 303.36万
• 依托单位: STANFORD UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6665492
• 关键词: brain electrical activity; clinical research; clinical trials; cognition; cognition disorders; cooperative study; emotions; human subject; human therapy evaluation; neuropsychological tests; nuclear magnetic resonance spectroscopy; patient oriented research; polysomnography; quality of life; respiratory therapy; sleep apnea

DESCRIPTION (provided by applicant): Nasal continuous positive airway pressure (CPAP) therapy is in widespread use as the primary treatment for the obstructive sleep apnea syndrome (OSAS), a sleep-related breathing disorder affecting more than 15 million Americans. The therapeutic effectiveness of CPAP in providing significant, stable, and long-term neurocognitive or other functional benefits to patients with OSAS has not been systematically investigated. The revised proposed study is a randomized, blinded, sham-controlled, multi-center trial of CPAP therapy. The principal aims of the study are: 1) to assess the long-term effectiveness of CPAP therapy on neurocognitive function, mood, sleepiness, and quality of life by administering tests of these indices to subjects randomly assigned to active or sham CPAP; 2) to identify specific neurocognitive deficits associated with OSAS in a large, heterogeneous subject population; 3) to determine which deficits in neurocognitive function in OSAS subjects are reversible and most sensitive to the effects of CPAP; 4) to develop a composite multivariate outcome measure from the results of this study that can be used to assess the clinical effectiveness of CPAP in improving neurocognitive function, mood, sleepiness, and quality of life; and 5) to use functional magnetic resonance imaging to compare cortical activation before and after CPAP therapy, and to assess whether this change is associated with improvement in specific neurocognitive task performance. The primary endpoint of this proposed study is the effect of 6 months of CPAP treatment on neurocognitive function. A total of 1050 subjects (525 per treatment group) will be enrolled from the patient populations at five sites (Stanford; U of Arizona; Harvard; St. Luke's Hospital, MO; St. Mary's Hospital, WA). This study will advance our knowledge of the major, most debilitating, clinically relevant OSAS-associated conditions, and, by scientifically establishing the effectiveness of CPAP therapy, should greatly improve access for the countless victims now denied treatment.

描述（由申请人提供）： 鼻连续阳性气道压力（CPAP）疗法广泛用作阻塞性睡眠呼吸暂停综合征（OSA）的主要治疗方法，这是一种影响超过1500万美国人的与睡眠有关的呼吸障碍。 CPAP在为OSA患者提供重要，稳定和长期神经认知或其他功能益处的治疗效果尚未系统地研究。 修订的拟议研究是一项随机，盲目的，虚假对照的CPAP治疗试验。 该研究的主要目的是：1）评估CPAP治疗对神经认知功能，情绪，嗜睡和生活质量的长期有效性，通过对随机分配为主动或假CPAP的受试者进行这些指数的测试； 2）确定与OSA相关的特定神经认知缺陷； 3）确定OSA受试者中神经认知功能的哪些缺陷是可逆的，并且对CPAP的影响最敏感； 4）从这项研究的结果中制定复合多元结果指标，可用于评估CPAP在改善神经认知功能，情绪，嗜睡和生活质量方面的临床有效性； 5）使用功能磁共振成像比较CPAP治疗前后的皮质激活，并评估这种变化是否与特定神经认知任务性能的改善有关。 这项拟议的研究的主要终点是6个月的CPAP治疗对神经认知功能的影响。 总共将在五个地点（斯坦福大学；亚利桑那州u;哈佛；密苏里州圣卢克医院；华盛顿州圣玛丽医院）中招募1050名受试者（每个治疗组525个）。 这项研究将提高我们对主要，最衰弱的，临床上相关的疾病的了解，并通过科学地建立CPAP治疗的有效性，应大大改善无数受害者现在拒绝治疗的机会。