Diagnosis and Treatment of Sleep Apnea in Women Veterans

女性退伍军人睡眠呼吸暂停的诊断和治疗

• 批准号: 10209949
• 负责人: Jennifer L Martin
• 金额: --
• 依托单位: VA GREATER LOS ANGELES HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-02-01 至 2022-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10209949
• 关键词: Accounting; Address; Adherence; Adopted; Anxiety; Area; Behavioral; Cardiovascular Diseases; Caring; Cause of Death; Clinical Management; Clinical Trials; Cognitive Therapy; Data; Diagnosis; Diagnostic; Disease; Drowsiness; Education; Fatigue; General Population; Goals; Health; Heart Diseases; Hour; Hypertension; Hypothyroidism; Intention; Intervention; Link; Literature; Measures; Mental Depression; Methods; Modeling; Monitor; Motivation; Outcome Study; Patient Education; Patient Self-Report; Patients; Population; Psychotherapy; Publishing; Quality of life; Randomized Controlled Trials; Recommendation; Reporting; Research; Sleep; Sleep Apnea Syndromes; Sleep Disorders; Sleep disturbances; Sleeplessness; Snoring; Statistical Methods; Techniques; Testing; Therapeutic; Veterans; Woman; Women' s Health; Work; adherence rate; adverse outcome; base; blood pressure reduction; depressive symptoms; design; efficacy testing; evidence base; experience; functional disability; high risk; improved; learning strategy; men; mindfulness; mortality; mortality risk; novel; poor sleep; preference; pressure; programs; psychologic; reduce symptoms; sleep quality; social factors; therapy adherence; treatment as usual; vehicular accident

Sleep disordered breathing (SDB) is associated with significant adverse health consequences including cardiovascular disease, motor vehicle accidents, daytime functional impairments and mortality risk. Although SDB is more common among men than women, it still impacts 17% of women in the general population. [Our preliminary evidence suggests it is even more common among women Veterans who receive VA care.] The recommended first-line therapy for most patients with SDB is positive airway pressure therapy (PAP). Published studies show that women have lower PAP adherence than men, particularly in the US, yet we are not aware of data comparing men and women Veterans. Because women Veterans experience significant sleep disturbance and other consequences of sleep disorders, adjusting to PAP therapy may be quite difficult. To date, studies have not tested interventions specifically designed to improve PAP adherence among women, accounting for important sleep-related and social factors. Since 2010 we have been studying sleep disorders among women Veterans, initially focusing on insomnia disorder. Through this work we discovered that a significant segment of women served by VA also are high risk for sleep disordered breathing (SDB; also referred to as sleep apnea), particularly if they report poor sleep. In treating insomnia, we found that the initial discomfort created by traditional cognitive-behavioral therapy for insomnia (e.g. initial sleep restriction) is difficult for many women Veterans to tolerate. We developed and are now testing an insomnia intervention based on Acceptance and Commitment Therapy (ACT), called “Acceptance and the Behavioral Changes to Treat Insomnia” or “ABC-I”. Within ACT, treatment focuses on a patient's values and reasons for implementing behavioral changes, and teaches the patient strategies for tolerating temporary discomfort in pursuit of goals consistent with one's values. We now propose to use these same therapeutic approach, adopted from ACT, to address unique challenges faced by women Veterans in adjusting to PAP therapy. This study is a randomized controlled trial (RCT) to test the efficacy of a program combining patient education with ACT-based techniques in improving adherence to PAP therapy, called “ABC-SA” or “Acceptance and the Behavioral Changes to treat Sleep Apnea.” This 6-session intervention will address initial discomfort, link treatment to the patient’s values and incorporate methods for accepting the changes that are required to treat SDB. Main study outcomes will be assessed 3 months after PAP initiation, and PAP adherence will be tracked remotely for 12 months. The 6-session “control” intervention will account for the contact with a study interventionist and will be modeled after usual care. The objectives of this proposal are: (1) to test the efficacy of the ABC-SA program in improving PAP adherence, compared to a control program modeled after usual care, for women Veterans with SDB; (2) to test the efficacy the ABC-SA program for improving objectively-measured and patient-reported sleep quality, compared to the control program; and (3), to test the efficacy the ABC-SA program for improving quality of life and symptoms of depression, compared to the control program. Data will be analyzed using “intention to treat” principles, using appropriate statistical methods for clinical trials.

睡眠呼吸障碍 (SDB) 与严重的不良健康后果相关，包括 cardiovascular disease, motor vehicle accidents, daytime functional impairments and mortality risk.虽然 SDB 在男性中比女性更常见，但仍影响总人口中 17% 的女性。 [我们的 初步证据表明，这种情况在接受退伍军人管理局护理的女性退伍军人中更为常见。] 对于大多数 SDB 患者推荐的一线治疗是气道正压治疗 (PAP)。 已发表的研究表明，女性的 PAP 依从性低于男性，尤其是在美国，但我们 不知道比较男性和女性退伍军人的数据。因为女性退伍军人经历了重大 睡眠障碍和睡眠障碍的其他后果，调整 PAP 治疗可能相当困难。 迄今为止，研究尚未测试专门为提高女性 PAP 依从性而设计的干预措施， 考虑重要的睡眠相关和社会因素。 自 2010 年以来，我们一直在研究女性退伍军人的睡眠障碍，最初关注失眠 紊乱。通过这项工作，我们发现 VA 服务的很大一部分女性也属于高风险人群 睡眠呼吸障碍（SDB；也称为睡眠呼吸暂停），特别是当他们报告睡眠质量不佳时。在 治疗失眠时，我们发现传统认知行为疗法最初带来的不适 对于许多女性退伍军人来说，失眠（例如最初的睡眠限制）很难忍受。我们开发并正在 现在正在测试一种基于接受和承诺疗法（ACT）的失眠干预措施，称为 “接受和改变行为来治疗失眠”或“ABC-I”。在 ACT 中，治疗重点是 患者的价值观和实施行为改变的原因，并教导患者策略 在追求与自己价值观一致的目标时容忍暂时的不适。我们现在建议使用这些 ACT 采用相同的治疗方法，以解决女性退伍军人面临的独特挑战 调整 PAP 治疗。 本研究是一项随机对照试验 (RCT)，旨在测试结合患者的方案的有效性 使用基于 ACT 的技术进行教育，以提高对 PAP 治疗的依从性，称为“ABC-SA”或 “治疗睡眠呼吸暂停的接受和行为改变。”这次为期 6 次的干预将解决最初的问题 不适，将治疗与患者的价值观联系起来，并结合接受变化的方法 需要治疗SDB。主要研究结果将在 PAP 开始后 3 个月进行评估，并且 PAP 遵守情况将被远程跟踪 12 个月。 6 次“控制”干预将考虑 与研究干预专家联系，并将按照常规护理进行建模。 本提案的目标是： (1) 测试 ABC-SA 计划在改善 PAP 方面的功效 与以常规护理为模型的对照计划相比，患有 SDB 的女性退伍军人的依从性； (2) 测试 ABC-SA 计划对于改善客观测量和患者报告的睡眠质量的功效， 与控制程序比较； (3)、测试 ABC-SA 计划改善生活质量的功效 和抑郁症状，与对照计划相比。将使用“意向治疗”来分析数据 原则，使用适当的统计方法进行临床试验。