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

失眠合并睡眠呼吸暂停的分级护理管理

• 批准号: 9339721
• 负责人: JACK D EDINGER
• 金额: $ 75.48万
• 依托单位: NATIONAL JEWISH HEALTH
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2021-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9339721
• 关键词: Address; Adherence; Adverse effects; Affect; Aftercare; Apnea; Behavioral; Caring; Chronic Insomnia; Cognitive; Comorbid Insomnia; Comorbidity; Control Groups; Data; Disease remission; Drowsiness; Education; Enrollment; Failure; Fatigue; Hygiene; Improve Access; Intervention; Knowledge; Measures; Methods; Modeling; Morbidity - disease rate; Obstructive Sleep Apnea; Outcome; Outcome Measure; Outcome Study; Patient Care; Patients; Pharmaceutical Preparations; Pittsburgh Sleep Quality Index; Process; Provider; Quebec; Questionnaires; Randomized; Randomized Clinical Trials; Reporting; Research; Residual state; Role; Sampling; Secondary Insomnia; Sedation procedure; Severities; Site; Sleep; Sleep Apnea Syndromes; Sleeplessness; Symptoms; Syndrome; Testing; Time; Training; actigraphy; care recipients; clinical practice; design; diaries; effective therapy; follow-up; functional outcomes; improved; indexing; interactive therapy; novel; pressure; primary outcome; programs; respiratory; response; treatment as usual; treatment effect; vigilance

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.

项目总结/摘要 阻塞性睡眠呼吸暂停（OSA）和慢性失眠是普遍的、使人衰弱的并且具有治疗挑战性的， 但它们共同出现的情况太常见，会放大发病率，并使受影响的管理复杂化。 患者不幸的是，以前的研究提供了有限的指导，什么是最好的，最 这一共病患者群体的实际管理方法。多种药物已获得FDA批准 失眠管理，但大多数尚未在合并OSA/失眠患者中进行测试。此外，委员会认为， 这些药物中的许多抑制呼吸驱动，使呼吸暂停症状恶化，而其他药物导致 残留镇静，对已经昏昏欲睡的阻塞性睡眠呼吸暂停综合征患者来说是一种不必要的副作用。一些有希望的初步数据 提示认知行为失眠治疗（CBT）可能是标准OSA安全有效辅助治疗 共病OSA/失眠症的治疗。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，并未能解决这一有希望的 考虑到目前能够提供治疗的供应商数量有限， 这项双中心随机临床试验将通过解决以下局限性来推动该领域的发展： 这是以前的研究。具体而言，该项目将使用“SMART”设计来测试一个阶梯式护理模式， 标准气道正压通气（PAP）治疗，并确定（1）使用OCBT加强PAP治疗 改善合并OSA/失眠症的短期结果;（2）提供更高强度的第二阶段CBT， OCBT+PAP治疗短期结局欠佳的患者可改善短期和长期结局。 入组的384名PAP治疗的合并OSA\失眠患者将完成基线评估， 症状特异性测量以及睡眠/觉醒功能的整体测量。然后他们将随机 分配至由UC单独治疗或PAP +OCBT组成的治疗。8周后，他们将重新评估， 在基线时采取的所有措施。达到缓解状态的患者（失眠严重程度指数评分< 10 +魁北克 睡眠问卷平均项目评分> 5）将不提供额外的失眠干预，但将继续 在额外8周后以及3个月和6个月时再次进行PAP和完整的研究结局测量 后续行动。治疗8周后被归类为“未缓解”的OCBT接受者将被重新随机分配至第2组， 阶段治疗包括持续、扩大与OCBT的接触或转向治疗师- 定向CBT（TCBT）。那些接受第二阶段干预以及UC组将重新评估 再过8周后，然后在3个月和6个月随访时间点再次进行。结果应该提供很多新的 这些信息极大地增强了我们对如何有效治疗OSA/失眠共病患者的知识 以及OCBT干预在该患者组的短期和长期管理中的作用。