Improving outcomes for patients with SDB and insufficient sleep

改善 SDB 和睡眠不足患者的预后

• 批准号: 10241257
• 负责人: M. Safwan Badr
• 金额: $ 71.24万
• 依托单位: WAYNE STATE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10241257
• 关键词: Address; Adherence; Adult; Aftercare; Apnea; Attention; Behavioral; Blood Pressure; Blood Vessels; Cardiovascular system; Clinical; Clinical Trials; Cognitive; Drowsiness; Education; Educational Intervention; Effectiveness; Endothelium; Epidemic; Failure; Fatigue; Future; Goals; Hour; Hypertension; Inflammatory Response; Intervention; Literature; Measures; Motivation; Outcome; Pathway interactions; Patient Preferences; Patient-Focused Outcomes; Patients; Peripheral; Sampling; Severities; Severity of illness; Sleep; Sleep Apnea Syndromes; Sleep Deprivation; Sleep Disorders; Symptoms; Testing; Time; Work; adequate sleep; adverse outcome; alertness; arterial tonometry; base; behavioral adherence; blood pressure reduction; blood pressure regulation; comparative; effectiveness evaluation; endothelial dysfunction; experience; follow-up; improved; improved outcome; indexing; innovation; mortality; patient oriented; patient subsets; pressure; programs; response; symptomatic improvement; therapy adherence; time use; treatment choice; trial design; vigilance

Sleepiness is a common presenting complaint in sleep centers, and sleep disordered breathing is a common cause; however, insufficient sleep occurs in over one third of US adults, but is not often addressed. This proposal is based on the premise that insufficient sleep contributes to sleepiness in patients with SDB, and may account for the variability in response to PAP therapy in patients with sleepiness and mild SDB. The objective is to determine the treatment that results in the greatest benefit to patients. We will also explore differences in blood pressure (BP outcomes) in those with hypertension. We will address the following Specific Aims: Specific Aim 1: demonstrate the effectiveness of a cognitive-behavioral sleep-time extension (STE) program compared to PAP in increasing objective alertness. Primary hypothesis 1 is that STE will be non- inferior to PAP therapy in increasing objective alertness [number of psychomotor vigilance testing (PVT) lapses]. If signs of superiority of STE over PAP are observed, we will test the Secondary Hypothesis that STE is superior to PAP in increasing objective alertness among patients with mild SDB. Specific Aim 2: To demonstrate the effectiveness of STE compared to PAP in reducing daytime sleepiness and fatigue. Primary Hypothesis 2 is that STE will be non-inferior to PAP therapy in reducing daytime sleepiness and fatigue. If signs of superiority of STE over PAP are observed, we will test the Secondary Hypothesis that STE will be superior to PAP in reducing daytime sleepiness and fatigue among patients with mild SDB. We also propose Exploratory Aim 3: To evaluate the effectiveness of STE compared to PAP in improving endothelial function and reducing blood pressure among the subset of patients with hypertension. Exploratory Hypothesis 3A is that, among patients hypertension, STE will be non-inferior to PAP in reducing blood pressure, and Exploratory Hypothesis 3B is that, among patients with hypertension, STE will be non-inferior to PAP in improving endothelial function. If signs of superiority of STE over PAP are observed, we will then we will test the superiority of STE to PAP in improving endothelial function and reducing blood pressure. We will address these aims by comparing the 4-session STE program to PAP therapy (with a 4-session PAP adherence program). We will also include a 4-session non-directive equal attention sleep education “control” (SEC) program. The STE program includes behavioral, cognitive and motivation enhancement strategies to increase sleep duration. Key outcomes will be measured pre- and post-treatment (1 month) and again at 3-months follow-up. Results will have significant impact regardless of the findings. If STE is superior to PAP in improving outcomes, patients with mild SDB should first be encouraged to obtain adequate sleep prior to initiation of PAP. If STE is non-inferior, either treatment may be viable, and can be based on patient preference. Conversely, superiority of PAP means a substantial emphasis on troubleshooting and enhancing acceptance and adherence is warranted.

嗜睡是睡眠中心中常见的抱怨，睡眠失调的呼吸是常见的 原因;但是，在我们三分之一的成年人中，睡眠不足发生，但经常没有解决。这 提案基于这样的前提，即睡眠不足会导致SDB患者的嗜睡和 在嗜睡和轻度SDB患者的子宫颈疾病治疗中，可能会说明可变性。 目的是确定对患者带来最大好处的治疗方法。我们还将探索 高血压患者的血压差异（BP结局）。我们将解决以下特定 目的：特定目的1：证明认知行为的睡眠时间延长的有效性（Ste） 与PAP相比，计划在增加客观警觉性方面。主要假设1是Ste将不是 不如PAP疗法在增加客观警觉性[精神病警戒测试的数量（PVT）中 失误]。如果观察到Ste胜过Pap的优势迹象，我们将测试次要假设 轻度SDB患者的客观警觉性增加了PAP。具体目标2： 与PAP相比，证明Ste在减少白天嗜睡和疲劳方面的有效性。基本的 假设2是，Ste在减少白天的嗜睡和疲劳方面将不属于PAP治疗。如果 观察到Ste胜过Pap的优势的迹象，我们将测试次要假设，即Ste将是 轻度SDB患者的白天嗜睡和疲劳，优于PAP。我们也建议 探索目的3：评估Ste与PAP相比在改善内皮功能方面的有效性 并降低高血压患者子集中的血压。探索性假设3a是 在降低血压和探索性的患者中，在患者中，Ste将不在PAP中 假设3b是，在高血压患者中，Ste在改进的情况下将不在PAP中。 内皮功能。如果观察到Ste STE优越的迹象，那么我们将测试 Ste至PAP的优势在改善内皮功能和降低血压方面。我们将解决 这些目的是将4条SESS计划与PAP疗法进行比较（具有4条经验的PAP依从性 程序）。我们还将包括4节非指导性的同等注意睡眠教育“控制”（SEC） 程序。 Ste计划包括行为，认知和动机增强策略以增加 睡眠持续时间。关键结果将在治疗前和治疗后（1个月），然后在3个月中再次测量 后续。无论发现如何，结果都将产生重大影响。如果Ste在改进方面优于PAP 结果，首先应鼓励患有轻度SDB的患者在开始之前获得足够的睡眠 帕普。如果Ste是非内部的，则两种治疗都可能是可行的，并且可以基于患者的偏好。 相反，PAP的优势意味着对故障排除和增强接受的重视 并有必要的依从性。