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

基本信息

批准号：
8699260
负责人：
Nalaka S Gooneratne
金额：
$ 23.52万
依托单位：
UNIVERSITY OF PENNSYLVANIA
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-08-15 至 2016-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8699260
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

项目摘要

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.

描述（由申请人提供）：失眠症状发生在高达30-50％的阻塞性睡眠呼吸暂停（OSA）患者中。失眠与OSA的普遍发生可能不仅有助于增加疾病负担，还可能代表OSA治疗依从性的实质性障碍。通常，OSA的失眠症是由OSA视为的（现有的临床护理指南中的）。在“原发性失眠”的患者中，睡眠起步和睡眠维持问题同样流行。相比之下，在OSA患者中，研究人员收集的初步数据表明，睡眠维持失眠症更为明显，CPAP治疗可能会改善睡眠维持，但不能减轻睡眠起始失眠。这引起了主要假设，即OSA患者失眠是一种异源性疾病，在某些情况下可能直接是由于OSA引起的，而在其他情况下，它与OSA无关。因此，研究人员提出了一项使用连续的正气道压力+接触控制（CPAP+CC）组，Sham-CPAP+CC组和CPAP+认知行为治疗失眠症（CPAP+CBT）的对照临床干预试验，Sham-CPAP+CC ARM和CPAP+认知行为疗法，以评估OSA治疗的程度，以评估这些效果是否限制为Insmention to Slevention to Smepent Insmia（是否限制了INSMIA）是否受到了INSMIA的限制（是否限制了INSMIA）是否有限制的INSMN效果（是否限制了Insmia for Insmia）是否受到了效果的影响。睡眠启动失眠（通常可能独立于OSA），以及CBT是否提供额外的好处。包括假cpap成分的包含是检验该假设的创新性和重要组成部分，因为在开放标签失眠症研究中可能会出现明显的安慰剂效应。与该计划公告的目标一致，拟议的研究设计是一项针对108名受试者的试验临床试验，有54例睡眠症状和54个WIH睡眠维持症状，他们将被随机分为CPAP+CC，Sham-CPAP+CC，或CPAP+CP+CPAP+CBT（双重双盲），因此创建了6组（每组18个受试者）（每组18个受试者）。该研究的目的包括评估CPAP，假CPAP和CPAP+CBT对失眠严重程度，白天结果（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中失眠症状的长期目标的至关重要的第一步，并将完成计划公告中概述的几个关键目标：1）确定OSA患者OSA患者中CPAP，Sham-CPAP和CPAP+CBT的可行性； 2）评估对研究干预的依从性，3）确定研究参数和协变量，以进行未来确定的多站点研究的样本量估计；特别重点将放在年龄，性别和种族等协变量的作用上。该提案具有重大的公共卫生后果，因为它代表了OSA中失眠症的一种新颖观点，挑战了现有的临床范式，将确定独立于OSA与失眠症的失眠症的特征，并最终可以通过对靶标的Insomnia治疗来补充CPAP治疗的患者来改善患者的依从性，以识别患者对CPAP治疗。