Insomnia and poor sleep are associated with an increased risk of developing cardiovascular disease (CVD) and its precursors, including hypertension. In 2022, the American Heart Association (AHA) added inadequate sleep to its list of health behaviors that increase the risk for CVD. It remains unknown, however, whether the successful treatment of insomnia and inadequate sleep can reduce heightened CVD risk. SLEEPRIGHT is a single-site, prospective clinical trial designed to evaluate whether the successful treatment of insomnia results in improved markers of CVD risk in patients with untreated hypertension and comorbid insomnia disorder. Participants (N = 150) will undergo baseline assessments, followed by a 6-week run-in period after which they will receive cognitive behavior therapy for insomnia (CBT-I), comprised of 6 hourly sessions with an experienced CBT-I therapist over a 6-week period. In addition to measures of insomnia severity, as well as both subjective and objective measures of sleep, the primary outcome measures are nighttime blood pressure (BP) and BP dipping assessed by 24-h ambulatory BP monitoring (ABPM). Secondary outcomes include several CVD risk biomarkers, including clinic BP, lipid profile, vascular endothelial function, arterial stiffness, and sympathetic nervous system (SNS) activity. Data analysis will evaluate the association between improvements in insomnia and sleep with primary and secondary CVD risk biomarker outcomes. The SLEEPRIGHT trial (ClinicalTrials.Gov NCT04009447) will utilize CBT-I, the current gold standard treatment for insomnia disorder, to evaluate whether reducing insomnia severity and improving sleep are accompanied by improved biomarkers of CVD risk in patients with untreated hypertension.

中文翻译：

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针对未治疗的高血压合并失眠症的失眠症的认知行为疗法：SLEEPRIGHT 临床试验

失眠和睡眠质量不佳会增加患心血管疾病 (CVD) 及其先兆症状（包括高血压）的风险。 2022 年，美国心脏协会 (AHA) 将睡眠不足​​添加到会增加 CVD 风险的健康行为清单中。然而，成功治疗失眠和睡眠不足是否可以降低心血管疾病风险仍不清楚。 SLEEPRIGHT 是一项单中心、前瞻性临床试验，旨在评估失眠的成功治疗是否会改善未经治疗的高血压和共病失眠症患者的 CVD 风险标志物。参与者（N  = 150）将接受基线评估，然后是为期 6 周的磨合期，之后他们将接受失眠认知行为疗法 (CBT-I)，该疗法包括由经验丰富的 CBT-I 治疗师进行的 6 小时疗程，持续时间超过为期 6 周的时间。除了失眠严重程度的测量以及睡眠的主观和客观测量之外，主要结果测量是夜间血压 (BP) 和通过 24 小时动态血压监测 (ABPM) 评估的血压下降。次要结果包括多种 CVD 风险生物标志物，包括临床血压、血脂、血管内皮功能、动脉僵硬度和交感神经系统 (SNS) 活动。数据分析将评估失眠和睡眠的改善与主要和次要CVD风险生物标志物结果之间的关联。 SLEEPRIGHT 试验 (ClinicalTrials.Gov NCT04009447) 将利用 CBT-I（目前治疗失眠症的金标准）来评估未经治疗的高血压患者在减轻失眠严重程度和改善睡眠的同时是否可以改善 CVD 风险的生物标志物。