Understanding the sleep apnea/insomnia interaction: a CPAP/sham-CPAP trial

了解睡眠呼吸暂停/失眠的相互作用：CPAP/假 CPAP 试验

• 批准号: 8384492
• 负责人: Nalaka S Gooneratne
• 金额: $ 24万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-08-15 至 2015-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8384492
• 关键词: Address; Adherence; Affect; Age; Characteristics; Classification; Clinical; Clinical Treatment; Clinical Trials; Cognitive Therapy; Complex; Continuous Positive Airway Pressure; Control Groups; Data; Diagnosis; Disease; Double-Blind Method; Ensure; Etiology; Exhibits; Fatigue; Future; Gender; Goals; Guidelines; High Prevalence; Hour; Impairment; International; Intervention; Intervention Studies; Intervention Trial; Maintenance; Masks; Measures; Middle Insomnia; NIH Program Announcements; Obstructive Sleep Apnea; Operative Surgical Procedures; Outcome; Participant; Patients; Pattern; Phenotype; Pilot Projects; Placebo Effect; Prevalence; Primary Insomnia; Public Health; Race; Randomized; Relative (related person); Research; Research Design; Research Personnel; Role; Sample Size; Severities; Site; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Sleeplessness; Specific qualifier value; Symptoms; Task Performances; Testing; United States; Work; abstracting; arm; burden of illness; clinical care; compliance behavior; design; disease classification; effectiveness trial; functional outcomes; improved; indexing; innovation; novel; open label; response; treatment adherence; vigilance

DESCRIPTION (provided by applicant): Insomnia symptoms occur in up to 30-50% of obstructive sleep apnea (OSA) patients. The prevalent co- occurrence of insomnia with OSA may not only serve to increase illness burden, it may also represent a substantial impediment to OSA treatment adherence. Insomnia in OSA has generally been viewed as a consequence of OSA (and is so specified in the existing clinical care guidelines). In patients with 'Primary Insomnia', sleep initiation and sleep maintenance problems occur with equal prevalence. In contrast, in patients with OSA, preliminary data gathered by the study investigators suggest that sleep maintenance insomnia is more pronounced and that CPAP treatment may ameliorate sleep maintenance but not sleep initiation insomnia. This gives rise to the primary hypothesis that insomnia in OSA patients is a heterogenous disorder which in some cases may be directly due to the OSA, while in others it is independent of the OSA. Accordingly, the investigators propose a controlled clinical intervention trial using a continuous positive airway pressure+contact control (CPAP+CC) arm, a sham-CPAP+CC arm and a CPAP+cognitive behavioral therapy for insomnia (CPAP+CBT) arm to assess the extent to which OSA treatment affects insomnia, whether these effects are limited to sleep maintenance insomnia (which is likely to be due to OSA) as opposed to sleep initiation insomnia (which may generally be independent of OSA), and whether CBT provides additional benefit. Inclusion of a sham-CPAP component is an innovative and essential component in testing this hypothesis because of the significant placebo effects that can occur in open-label insomnia research. Consistent with the goals of the Program Announcement, the proposed study design is a pilot clinical trial of 108 subjects, 54 with sleep initiation symptoms and 54 wih sleep maintenance symptoms, who will be randomized to CPAP+CC, sham- CPAP+CC, or CPAP+CBT (double-blind), thus creating six groups (18 subjects per group). The study aims include assessing CPAP, sham-CPAP, and CPAP+CBT effects on insomnia severity, daytime outcomes (both subjective and objective) and objectively measured CPAP adherence. The proposed pilot study is a crucial first step in the long-term objective of effectively treating insomnia symptoms in OSA and would accomplish several key goals as outlined in the program announcement: 1) Determine the feasibility of CPAP, sham-CPAP, and CPAP+CBT in OSA patients with insomnia; 2) Assess adherence to the study intervention and 3) Identify study parameters and covariates for sample size estimates for a future definitive multi-site study; particular emphasis will be placed on the role of covariates such as age, gender and race. The proposal has significant public health ramifications in that it represents a novel perspective on insomnia in OSA that challenges existing clinical paradigms, will identify characteristics of insomnia independent from OSA versus insomnia due to OSA, and could ultimately improve patient adherence to CPAP therapy by identifying patients who warrant targeted insomnia therapy that will supplement their CPAP therapy. PUBLIC HEALTH RELEVANCE: Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial. (End of Abstract)

描述（由申请人提供）： 高达 30-50% 的阻塞性睡眠呼吸暂停 (OSA) 患者会出现失眠症状。失眠与 OSA 的普遍并发不仅会增加疾病负担，还可能严重阻碍 OSA 治疗的依从性。 OSA 中的失眠通常被视为 OSA 的后果（并且在现有的临床护理指南中如此指定）。在“原发性失眠”患者中，睡眠启动和睡眠维持问题的发生率相同。相比之下，在 OSA 患者中，研究人员收集的初步数据表明，睡眠维持性失眠更为明显，CPAP 治疗可能会改善睡眠维持，但不会改善睡眠启动性失眠。这就产生了一个主要假设：OSA 患者的失眠是一种异质性疾病，在某些情况下可能直接由 OSA 引起，而在其他情况下则与 OSA 无关。因此，研究人员提出了一项对照临床干预试验，使用持续气道正压通气+接触控制（CPAP+CC）组、假CPAP+CC组和CPAP+失眠认知行为疗法（CPAP+CBT）组来评估OSA治疗对失眠的影响程度，这些影响是否仅限于睡眠维持性失眠（可能是由于OSA）而不是睡眠维持性失眠。 睡眠开始失眠（通常可能与 OSA 无关），以及 CBT 是否提供额外的益处。由于在开放标签失眠研究中可能出现显着的安慰剂效应，因此纳入假 CPAP 成分是检验这一假设的创新且重要的组成部分。与计划公告的目标一致，拟议的研究设计是一项试点临床试验，共有 108 名受试者参与，其中 54 名有睡眠启动症状，54 名有睡眠维持症状，这些受试者将被随机分配至 CPAP+CC、假 CPAP+CC 或 CPAP+CBT（双盲）组，从而创建 6 组（每组 18 名受试者）。该研究的目的包括评估 CPAP、假 CPAP 和 CPAP+CBT 对失眠严重程度、日间结果（主观和客观）的影响以及客观测量的 CPAP 依从性。拟议的试点研究是有效治疗 OSA 失眠症状这一长期目标的关键第一步，并将实现项目公告中概述的几个关键目标： 1) 确定 CPAP、假 CPAP 和 CPAP+CBT 在 OSA 失眠患者中的可行性； 2) 评估对研究干预的遵守情况，以及 3) 确定研究参数和协变量，以用于未来确定性多中心研究的样本量估计；将特别强调年龄、性别和种族等协变量的作用。该提案具有重大的公共卫生影响，因为它代表了 OSA 失眠的新视角，挑战了现有的临床范式，将确定独立于 OSA 的失眠与 OSA 引起的失眠的特征，并通过确定需要有针对性的失眠治疗来补充 CPAP 治疗的患者，最终可以提高患者对 CPAP 治疗的依从性。 公共卫生相关性： 近一半的阻塞性睡眠呼吸暂停患者有失眠症状，在某些情况下（但不是全部），这些失眠症状是由阻塞性睡眠呼吸暂停引起的。本研究的目的是找出什么类型的失眠症状是由阻塞性睡眠呼吸暂停引起的，因此最有可能对持续气道正压通气（也称为 CPAP）的阻塞性睡眠呼吸暂停治疗有反应，以及认知行为疗法对失眠的额外治疗是否有益。 （摘要完）