Duke University Medical Center, Durham, North Carolina, USA.
University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
J Clin Hypertens (Greenwich). 2024 Apr;26(4):441-447. doi: 10.1111/jch.14763. Epub 2024 Mar 11.
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.
失眠和睡眠质量差与心血管疾病（CVD）及其前体的风险增加有关，包括高血压。2022 年，美国心脏协会（AHA）将睡眠不足添加到增加 CVD 风险的健康行为清单中。然而，目前尚不清楚失眠和睡眠不足的成功治疗是否可以降低 CVD 风险。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合并失眠症患者的 CVD 风险标志物。参与者（N=150）将进行基线评估，然后进行 6 周的导入期，之后他们将接受认知行为疗法治疗失眠症（CBT-I），包括 6 次与经验丰富的 CBT-I 治疗师进行的 6 周治疗。除了失眠严重程度以及主观和客观睡眠测量外，主要结局测量指标还包括通过 24 小时动态血压监测（ABPM）评估夜间血压（BP）和 BP 下倾。次要结局包括几个 CVD 风险生物标志物，包括诊所 BP、血脂谱、血管内皮功能、动脉僵硬和交感神经系统（SNS）活性。数据分析将评估失眠和睡眠改善与主要和次要 CVD 风险生物标志物结局之间的关联。SLEEPRIGHT 试验（ClinicalTrials.Gov NCT04009447）将利用 CBT-I，这是失眠症的当前金标准治疗方法，评估减轻失眠严重程度和改善睡眠是否伴有未经治疗的高血压患者的 CVD 风险生物标志物改善。
