APPLES: Apnea Positive Pressure Long-Term Efficacy Study

描述(由申请人提供)： 鼻腔持续正压(CPAP)治疗被广泛用作阻塞性睡眠呼吸暂停综合征(OSAS)的主要治疗方法，OSAS是一种与睡眠相关的呼吸障碍，影响着1500多万美国人。CPAP在为OSAS患者提供显著、稳定和长期的神经认知或其他功能益处方面的疗效尚未得到系统研究。修订后的拟议研究是一项随机、盲法、假对照、多中心的CPAP治疗试验。这项研究的主要目的是：1)通过对随机分配到活动或假CPAP的受试者进行这些指标的测试，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；2)在大量、不同种类的受试者中确定与OSAS相关的特定神经认知缺陷；3)确定OSAS受试者中哪些神经认知功能缺陷是可逆的，对CPAP的影响最敏感；4)根据本研究的结果开发一个综合的多变量结果测量方法，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治疗前后大脑皮质的激活，并评估这种变化是否与特定神经认知任务绩效的改善有关。 这项拟议研究的主要终点是6个月的CPAP治疗对神经认知功能的影响。总共1050名受试者(每个治疗组525人)将从5个地点的患者中招募(斯坦福大学；亚利桑那大学；哈佛大学；密苏里州圣卢克医院；华盛顿州圣玛丽医院)。这项研究将促进我们对主要的、最虚弱的、与临床相关的阻塞性睡眠呼吸暂停综合征相关疾病的了解，并通过科学地建立CPAP治疗的有效性，应该会极大地改善现在拒绝接受治疗的无数患者的机会。

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.