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.

项目摘要/摘要 阻塞性睡眠呼吸暂停（OSA）和慢性失眠是普遍的，令人衰弱的和挑战，可以治疗， 但是它们太常见的共发生放大器发病率，使受影响的管理变得复杂 患者。不幸的是，以前的研究为构成最佳和最佳的最佳指导提供了有限的指导 该合并症患者组的实用管理方法。各种药物已获得FDA的批准 失眠治疗，但大多数尚未在合并症OSA/失眠患者中进行测试。而且， 这些药物中的许多抑制呼吸驱动使呼吸暂停症状恶化，而其他呼吸症则导致 残留镇静，对已经困了的OSA患者的副作用。一些承诺初步数据 建议认知行为失眠治疗（CBT）可能是标准OSA的安全有效的辅助手段 合并OSA/失眠的疗法。但是，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，并且未能解决这一问题 鉴于目前有限的提供者，可以使治疗更广泛地获得 交付它。这项双站点随机临床试验将通过解决的局限 这是先前的研究。具体而言，该项目将使用“智能”设计来测试阶梯护理模型相关 标准阳性气道压力（PAP）疗法，并确定（1）使用OCBT的PAP治疗是否增加 改善合并症OSA/失眠的短期结局； （2）提供更高强度的第二阶段CBT 用OCBT+PAP表现出最佳短期结局的患者可改善短期和长期结局。 384个由PAP处理的合并症OSA \失眠症患者将完成基线评估 综合征特异性的度量以及全球睡眠/唤醒功能的度量。然后他们会随机 分配给由单独使用UC或PAP +OCBT组成的治疗。 8周后，他们将重新评估 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 睡眠问卷的平均项目得分> 5）将不提供其他失眠干预措施，但会继续 PAP和完整的研究结果度量再次进行8周后，在3个月和6个月时再次 后续行动。 8周的治疗后，OCBT接受者将被归类为“不舒服” 舞台治疗包括持续，扩大与OCBT或转换为治疗师的互动 - 定向CBT（TCBT）。那些接受第二阶段干预以及UC组的人将被重新评估 再过8周，然后在3个月和6个月的随访时间点再次。结果应提供很多新的 大大增强了我们有关如何有效治疗合并症OSA/失眠患者的知识的信息 关于OCBT干预在该患者组的短期和长期管理中的作用。