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.

项目概要/摘要 阻塞性睡眠呼吸暂停 (OSA) 和慢性失眠很普遍，使人衰弱且难以治疗， 但它们太常见的同时出现加剧了发病率并使受影响的管理变得复杂 不幸的是，之前的研究对于什么是最好和最有效的指导提供了有限的指导。 针对这一共病患者群体的实用管理方法已获得 FDA 批准。 失眠管理，但大多数尚未在 OSA/失眠共病患者中进行测试。 其中许多药物会抑制呼吸驱动，使呼吸暂停症状恶化，而其他药物则导致 残余镇静，对于已经昏昏欲睡的 OSA 患者来说是一种不必要的副作用 一些有希望的初步数据。 表明认知行为失眠疗法 (CBT) 可能是标准 OSA 的安全有效的辅助疗法 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，并且未能解决这一有希望的问题 鉴于目前有能力提供治疗的提供者数量有限，可以使治疗更广泛地获得 这项双中心随机临床试验将通过解决该领域的局限性来推动该领域的发展。 具体来说，该项目将使用“SMART”设计来测试相对的阶梯式护理模型。 标准气道正压 (PAP) 治疗并确定是否 (1) 使用 OCBT 增强 PAP 治疗 改善合并 OSA/失眠的短期结果；(2) 提供更高强度的第二阶段 CBT OCBT+PAP 短期结果不佳的患者可以改善短期和长期结果。 入组的 384 名接受 PAP 治疗的合并症 OSA\失眠患者将完成基线评估 然后，针对特定症状的测量以及睡眠/觉醒功能的整体测量将是随机的。 分配至单独 UC 或 PAP + OCBT 治疗组，8 周后将对其进行重新评估。 达到缓解状态的患者（失眠严重程度指数评分 < 10 + 魁北克） 睡眠问卷平均项目得分> 5）将不提供额外的失眠干预，但将继续 额外 8 周后再次进行 PAP 和完整研究结果测量，并在 3 个月和 6 个月时再次进行测量 治疗 8 周后被分类为“未缓解”的 OCBT 接受者将被重新随机分配到第二组。 阶段治疗包括持续、扩大 OCBT 的参与或转向治疗师 - 接受第二阶段干预的患者以及 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进行，结果应该会提供很多新的结果。 这些信息极大地增强了我们对如何有效治疗 OSA/失眠共病患者的了解 以及 OCBT 干预在该患者群体的短期和长期管理中的作用。