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

一项针对患有 PTSD 和复杂失眠的非依从 CPAP 退伍军人的失眠症的实用随机对照试验

• 批准号: 9771627
• 负责人: Ali A El Solh
• 金额: --
• 依托单位: VA WESTERN NEW YORK HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-10-01 至 2023-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9771627
• 关键词: Address; Adherence; Area; Assimilations; Awareness; Beck depression inventory; Behavior; Behavior Therapy; Case Management; Clinical; Clinical Trials; Cognitive Therapy; Combined Modality Therapy; Comorbid Insomnia; Comparative Study; Complex; Consensus; Continuous Positive Airway Pressure; Development; Diagnosis; Disease; Distress; Dreams; Drowsiness; Effectiveness; Eszopiclone; Evaluation; Fatigue; Guidelines; Health Technology; Impairment; Investigation; Label; Lead; Masks; Measures; Mental Depression; Methods; Military Personnel; Modality; Modeling; Morbidity - disease rate; Night Terrors; Nightmare; Obstructive Sleep Apnea; Outcome; Pain; Panic Attack; Participant; Patients; Pittsburgh Sleep Quality Index; Placebos; Post-Traumatic Stress Disorders; Primary Insomnia; Psychometrics; Quality of life; Randomized; Randomized Clinical Trials; Reporting; Risk Factors; Severities; Sleep; Sleep Apnea Syndromes; Sleep Architecture; Sleep Disorders; Sleep disturbances; Sleeplessness; Symptoms; Testing; Therapeutic; Time; Translating; Treatment Protocols; Veterans; Waiting Lists; Work; actigraphy; anxiety symptoms; chronic pain; cognitive function; combat; comorbidity; comparative effectiveness; compare effectiveness; effective therapy; evidence base; experience; follow-up; hypnotic; improved; indexing; instrument; mHealth; personalized medicine; physical conditioning; post-traumatic symptoms; psychiatric symptom; response; sedative; sleep onset; sleep quality; suicide rate; therapy adherence; treatment effect

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.

多达90%的患有创伤后应激障碍（PTSD）的退伍军人报告做噩梦， 失眠，甚至当排除噩梦，睡眠障碍是最普遍的症状， PTSD患者中约有50%-70%患有睡眠障碍。典型的睡眠 主诉包括噩梦、痛苦的觉醒、夜间恐慌发作、睡眠恐惧和失眠。 虽然创伤后应激障碍会导致睡眠障碍和不良的临床结果， 目前的研究表明，睡眠障碍也是导致创伤后应激障碍的一个危险因素。 在军事人员与战斗暴露，共病失眠症和阻塞性睡眠呼吸暂停综合征，一个条件，最初标记为 因为“复杂性失眠”已经成为最具挑战性的睡眠障碍之一。在 PTSD的存在、OSA和失眠的共同发生也与显著的发病率相关。 患有创伤后应激障碍和复杂失眠症的退伍军人报告更多的精神症状，慢性疼痛， 自杀率。此外，这些退伍军人可能更难坚持CPAP，因为增加了 由于频繁醒来而意识到面罩，并且无法带着面罩开始或返回睡眠 到位幸运的是，这些睡眠障碍都有有效的治疗方法。传统治疗 模型包括首先治疗OSA，然后只有在 对CPAP的反应被视为不满意。然而，在退伍军人中观察到的次优反应 从生活质量、PTSD症状和持续气道正压通气依从性方面来看， 需要研究其他治疗方法。目前，我们并没有就 治疗患有创伤后应激障碍的退伍军人复杂失眠症的最佳策略。 此前的研究表明，认知行为疗法（CBT）对治疗失眠有效 与催眠药相比。联合治疗是否比CBT具有治疗优势 单独用于患有PTSD的退伍军人的复杂失眠症尚未确定。本提案的目的是 进行一项实用的、随机的、平行的临床试验， 治疗退伍军人失眠（BBTI-MV）加右佐匹克隆，一种非苯二氮卓类催眠药， 在52名患有PTSD和OSA的战斗暴露退伍军人中，与BBTI-MV单独治疗相比， 总体睡眠生活质量、PTSD症状和CPAP依从性。本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满足需求。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质量的影响; 2）联合治疗的有效性 CBT和右佐匹克隆治疗与CBT单独治疗在改善睡眠质量和PTSD症状方面的比较;以及3） 每种治疗方案对CPAP依从性的影响。通过建立最有效的治疗方法， 减轻失眠，使患有创伤后应激障碍的退伍军人中OSA的存在复杂化，更高的CPAP依从性 最终将转化为认知功能的改善、生活质量的提高和PTSD的抑制 症状这项试验的长期益处也将带来更个性化治疗的机会 包括通过移动的卫生技术提供的方法， 几个领域。