Improving outcomes for patients with SDB and insufficient sleep

改善 SDB 和睡眠不足患者的预后

基本信息

批准号：
10689812
负责人：
M. Safwan Badr
金额：
$ 61.37万
依托单位：
WAYNE STATE UNIVERSITY
依托单位国家：
美国
项目类别：
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/10689812
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 Symptoms Testing Time Work adequate sleep adverse outcome alertness arterial tonometry 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

项目摘要

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然而，超过三分之一的美国成年人存在睡眠不足的问题，但这一问题并未得到解决。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。我们还将探索能够为患者带来最大益处的治疗方法。高血压患者血压（BP 结果）的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的作用主要假设 1 是 STE 将是非非的。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。假设 2 是，STE 在减少白天嗜睡和疲劳方面不逊色于 PAP 疗法。观察到 STE 优于 PAP 的迹象，我们将检验次要假设，即 STE 将我们还建议，在减少轻度 SDB 患者白天嗜睡和疲劳方面，PAP 优于 PAP。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探索性假设 3A 是降低高血压患者的血压。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 如果观察到 STE 优于 PAP 的迹象，我们将测试我们将讨论 STE 相对于 PAP 在改善内皮功能和降低血压方面的优越性。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)。 STE 计划包括行为、认知和动机增强策略，以提高。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。无论结果如何，后续行动都会产生重大影响。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如果 STE 不较差，则任何一种治疗方法都可能可行，并且可以根据患者的偏好而定。在线，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。