Stepped-care management of insomnia co-occurring with sleep apnea

项目摘要/摘要 阻塞性睡眠呼吸暂停(OSA)和慢性失眠很普遍，使人虚弱，治疗起来很有挑战性， 但它们太常见的同时发生放大了发病率，并使受影响的管理复杂化。 病人。不幸的是，之前的研究提供了有限的指导，关于什么是最好的和最 针对这一并存患者群体的实用管理方法。各种药物都有FDA的批准 失眠治疗，但大多数尚未在合并阻塞性睡眠呼吸暂停/失眠患者中进行测试。此外， 其中许多药物抑制呼吸驱动，使呼吸暂停症状恶化，而其他药物则导致 残留镇静，对于已经昏昏欲睡的OSA患者来说是一个不想要的副作用。一些有希望的初步数据 提示认知行为失眠疗法(CBT)可能是标准OSA的一种安全有效的辅助疗法 治疗并存的阻塞性睡眠呼吸暂停综合症/失眠。然而，报告这些发现的研究包括小患者 样本，缺乏对照组和足够的随访期，也没有解决这一前景如何 鉴于目前能够提供治疗的提供者数量有限，可以更广泛地获得治疗 把它送来。这项双部位随机临床试验将通过解决以下限制而推动该领域的发展 这是前人的研究。具体地说，这个项目将使用“智能”设计来测试一个相对的阶梯式护理模型 标准的气道正压(PAP)治疗并确定(1)OCBT对PAP治疗的增强作用 改善并发阻塞性睡眠呼吸暂停/失眠的短期结果；以及(2)提供更高强度的第二阶段CBT 接受OCBT+PAP治疗的患者短期效果不佳，可改善短期和长期效果。 纳入的384名接受PAP治疗的OSA/失眠患者将完成基线评估，包括 针对特定症状的测量以及睡眠/清醒功能的全球测量。然后他们将被随机 分配到由UC单独或PAP+OCBT组成的治疗组。8周后，他们将被重新评估 在基线上采取的所有措施。达到缓解状态的患者(失眠严重程度指数评分&lt；10+魁北克 睡眠问卷平均条目分数将不会被提供额外的失眠干预，但将继续 在额外的8周后，以及在3个月和6个月时再次进行PAP和完成研究结果测量 后续行动。接受OCBT治疗8周后被归类为“未缓解”的患者将被重新随机分成第二组-- 阶段性治疗包括继续、扩大与OCBT的接触或转向治疗师- 定向CBT(TCBT)。接受第二阶段干预的人以及UC组将被重新评估 再过8周，然后在3个月和6个月的随访时间点再次观察。结果应该会提供更多新的 极大地增强了我们对如何有效治疗OSA/失眠患者的知识的信息 以及OCBT干预在这一患者群体的短期和长期管理中的作用。

PROJECT SUMMARY/ABSTRACT Obstructive sleep apnea (OSA) and chronic insomnia are prevalent, debilitating, and challenging to treat, but their all too common co-occurrence amplifies morbidity and complicates the management of affected patients. Unfortunately, previous research provides limited guidance as to what constitutes the best and most practical management approach for this comorbid patient group. Various medications have FDA approval for insomnia management, but most have not been tested among comorbid OSA/insomnia patients. Moreover, many of these agents suppress respiratory drive making apnea symptoms worse, whereas others result in residual sedation, an unwanted side effect for the already sleepy OSA patient. Some promising preliminary data suggest that cognitive-behavioral insomnia therapy (CBT) may be a safe and effective adjunct to standard OSA therapies for comorbid OSA/insomnia. However, studies reporting these findings have included small patient samples, lacked both control groups and adequate follow-up periods, and failed to address how this promising therapy can be made more broadly accessible given the currently limited number of providers capable of delivering it. This dual-site randomized clinical trial will move the field forward by addressing the limitations of this previous studies. Specifically this project will use a “SMART” design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with OCBT improves short-term outcomes of comorbid OSA/insomnia; and (2) providing a higher intensity 2nd-stage CBT to patients who show sub-optimal short-term outcomes with OCBT+PAP improves short and longer-term outcomes. The 384 PAP-treated comorbid OSA\insomnia patients enrolled will complete baseline assessment with sets of syndrome-specific measures as well as global measures of sleep/wake functioning. They then will be randomly assigned to a treatment consisting of the UC alone or PAP +OCBT. After 8 weeks they will be reassessed with all measures taken at baseline. Patients reaching remission status (insomnia severity index score < 10 + Quebec Sleep Questionnaire mean item score > 5) will be offered no additional insomnia intervention but will continue PAP and complete study outcome measures again after an additional 8-weeks and again at 3 and 6 month follow-ups. OCBT recipients classified as “unremitted” after 8-weeks of treatment will be re-randomized to a 2nd- stage treatment consisting of a continued, expanded engagement with the OCBT or a switch to a therapist- directed CBT (TCBT). Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and then again at 3- and 6-month follow-up time points. Results should provide much new information that greatly enhances our knowledge about how to effectively treat comorbid OSA/insomnia patients and about the role of OCBT intervention in the short- and longer term management of this patient group.