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: 10488651
• 负责人: M. Safwan Badr
• 金额: $ 71.42万
• 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/10488651
• 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; hypertensive; improved; improved outcome; indexing; innovation; mortality; patient oriented; patient subsets; positive airway pressure; 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.

嗜睡是睡眠中心常见的主诉，睡眠呼吸障碍是常见的症状 原因;然而，超过三分之一的美国成年人都存在睡眠不足的问题，但往往没有得到解决。这 该提案的前提是睡眠不足会导致 SDB 患者嗜睡，并且 可能是嗜睡和轻度 SDB 患者对 PAP 治疗反应差异的原因。这 目标是确定给患者带来最大益处的治疗方法。我们还将探索 高血压患者的血压（BP 结果）存在差异。我们将解决以下具体问题 目标：具体目标 1：证明认知行为睡眠时间延长 (STE) 的有效性 与 PAP 相比，该计划在提高客观警觉性方面有所提高。主要假设 1 是 STE 将是非 在提高客观警觉性方面不如 PAP 疗法 [精神运动警觉性测试 (PVT) 数量 失误]。如果观察到 STE 优于 PAP 的迹象，我们将检验次要假设：STE 在提高轻度 SDB 患者的客观警觉性方面优于 PAP。具体目标 2： 证明 STE 与 PAP 相比在减少白天嗜睡和疲劳方面的有效性。基本的 假设 2 是，STE 在减少白天嗜睡和疲劳方面不逊于 PAP 疗法。如果 观察到 STE 优于 PAP 的迹象，我们将检验次要假设，即 STE 将 在减少轻度 SDB 患者白天嗜睡和疲劳方面优于 PAP。我们还建议 探索性目标 3：评估 STE 与 PAP 相比在改善内皮功能方面的有效性 降低高血压患者的血压。探索性假设 3A 是 在高血压患者中，STE 在降低血压方面不逊色于 PAP，探索性 假设 3B 是，在高血压患者中，STE 在改善血压方面不逊色于 PAP 内皮功能。如果观察到 STE 优于 PAP 的迹象，我们将测试 STE 在改善内皮功能和降低血压方面优于 PAP。我们将解决 通过将 4 个疗程的 STE 计划与 PAP 治疗（4 个疗程的 PAP 依从性）进行比较来实现这些目标 程序）。我们还将包括一个为期 4 节的非指导性平等注意力睡眠教育“控制”(SEC) 程序。 STE 计划包括行为、认知和动机增强策略，以提高 睡眠持续时间。主要结果将在治疗前和治疗后（1 个月）以及 3 个月时再次测量 后续行动。无论调查结果如何，结果都会产生重大影响。如果 STE 在改善方面优于 PAP 根据结果​​，应首先鼓励轻度 SDB 患者在开始治疗前获得充足的睡眠 子宫颈癌。如果 STE 不较差，则任何一种治疗方法都可能可行，并且可以基于患者的偏好。 相反，PAP 的优越性意味着非常重视故障排除和提高接受度 并且遵守是有保证的。