A pragmatic randomized comparator trial of eszopiclone and brief behavioral therapy for insomnia in CPAP non adherent Veterans with PTSD and complex insomnia

高达90%的患有创伤后应激障碍(PTSD)的退伍军人报告说做噩梦和 失眠，即使不包括噩梦，睡眠障碍也是最常见的症状 大约50%-70%的患者患有创伤后应激障碍。典型的睡眠 主诉包括噩梦、痛苦的觉醒、夜间恐慌症发作、睡眠恐惧和失眠。 虽然创伤后应激障碍会引起睡眠障碍并对临床结果产生负面影响，但这一点早已得到证实。 目前的研究表明，睡眠障碍也是导致创伤后应激障碍的危险因素。 在有战斗暴露、共病失眠和阻塞性睡眠呼吸暂停综合征的军事人员中，一种最初被标记为 “复杂性失眠”已成为最具挑战性的睡眠障碍之一。在 创伤后应激障碍的存在、阻塞性睡眠呼吸暂停和失眠的并存也与显著的发病率有关。 同时患有创伤后应激障碍和复杂性失眠的退伍军人表现出更多的精神症状、慢性疼痛和更高的 自杀率。此外，这些退伍军人可能更难坚持CPAP，因为 由于频繁唤醒和不能启动或返回使用面罩睡觉而意识到面罩 就位了。幸运的是，这些睡眠障碍都有有效的治疗方法。传统治疗 模式包括首先治疗阻塞性睡眠呼吸暂停综合症，然后辅以或同时治疗失眠，只有在 对CPAP的反应被认为不令人满意。然而，在退伍军人中观察到的次优反应 从生活质量、创伤后应激障碍症状和CPAP依从性方面来看，这种方法导致的创伤后应激障碍 有必要审查替代治疗方式。目前，政府并没有就 治疗患有创伤后应激障碍的退伍军人复杂性失眠的最佳策略。 先前的研究表明，认知行为疗法(CBT)对治疗失眠有效 与催眠剂相比。联合疗法是否比CBT更具治疗优势 对于患有创伤后应激障碍的退伍军人中复杂失眠的单独治疗尚不确定。这项提议的目标是 进行一项务实、随机、平行的临床试验，比较简明行为疗法的疗效 退伍军人失眠治疗(BBTI-MV)加非苯二氮类催眠药埃索匹龙， 52名患有创伤后应激障碍和阻塞性睡眠呼吸暂停并伴有失眠的退伍军人与单纯BBTI-MV对照 全球睡眠生活质量、创伤后应激障碍症状和CPAP依从性。该主题涉及几个关键领域 患有创伤后应激障碍和睡眠呼吸障碍的退伍军人的未得到满足的需求。其中包括：1)协会 复杂性失眠和创伤后应激障碍对整体睡眠生活质量的影响；2)联合治疗的有效性 在改善睡眠质量和创伤后应激障碍症状方面，CBT和埃索匹克隆的治疗与CBT单独治疗相比； 各治疗方案对CPAP依从性的影响。通过建立最有效的治疗方法 缓解伴有创伤后应激障碍、更高的CPAP依从性的退伍军人合并OSA的失眠 最终将转化为认知功能的改善、生活质量的提高和创伤后应激障碍的抑制 症状。这项试验的长期好处也将带来更多个性化治疗的机会 包括通过移动医疗技术提供的方法，这将允许更大程度地吸收 几个域。

As many as 90% of Veterans with posttraumatic stress disorder (PTSD) report nightmares and insomnia and even when nightmares are excluded, sleep disturbances are the most prevalent symptoms of PTSD with roughly 50%-70% of patients suffering from co-occurring sleep disorders. The typical sleep complaints include nightmares, distressed awakenings, nocturnal panic attacks, sleep terrors and insomnia. While it has long been established that PTSD engenders sleep disturbances and averse clinical outcomes, current investigations indicate that disordered sleep is also a risk factor for the development of PTSD. In military personnel with combat exposure, comorbid insomnia and OSA, a condition originally labeled as “complex insomnia” has emerged as one of the most challenging sleep disorder to manage. In the presence of PTSD, the co-occurrence of OSA and insomnia is also associated with significant morbidity. Veterans with both PTSD and complex insomnia report more psychiatric symptoms, chronic pain, and higher rates of suicide. Further, these Veterans may have more difficulty adhering to CPAP because of increased awareness of the mask due to frequent awakenings and an inability to initiate or return to sleep with the mask in place. Fortunately, there are effective treatments for each of these sleep disorders. Traditional treatment models consist of treating OSA first, followed by adjunctive or concurrent treatment for insomnia only if the response to CPAP is deemed unsatisfactory. However, the suboptimal response observed in Veterans with PTSD from such an approach in terms of quality of life, PTSD symptoms, and CPAP adherence highlights the need to examine alternative modalities of treatment. At present, there are no general guidelines on the best strategy to treat complex insomnia in Veterans with PTSD. Prior studies have shown that cognitive behavioral therapy (CBT) is effective for treating insomnia when compared with hypnotic agents. Whether combination therapy offers a therapeutic advantage over CBT alone for complex insomnia in Veterans with PTSD is yet to be determined. The objective of this proposal is to conduct a pragmatic, randomized, parallel clinical trial comparing the effectiveness of Brief Behavioral Therapy for Insomnia in Military Veterans (BBTI-MV) plus eszopiclone, a non-benzodiazepine hypnotic, versus BBTI-MV alone in 52 combat-exposed Veterans with PTSD and OSA with coexisting insomnia on global sleep quality of life, PTSD symptoms, and CPAP adherence. The topic addresses several key areas of unmet needs for Veterans with PTSD and sleep disordered breathing. Among these are: 1) the association between complex insomnia and PTSD on global sleep quality of life; and 2) the effectiveness of combined treatment of CBT and eszopiclone versus CBT alone in improving sleep quality and PTSD symptoms; and 3) the impact of each treatment regimen on CPAP adherence. By establishing the most effective therapy in alleviating insomnia that complicates the presence of OSA in Veterans with PTSD, higher CPAP adherence will ultimately translate into improved cognitive function, enhanced quality of life, and suppression of PTSD symptoms. The long term benefit of this trial will also lead to opportunities for more personalized treatment including delivery method via mobile health technologies which will allow greater assimilation of results across several domains.