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.

嗜睡是睡眠中心常见的主诉，睡眠呼吸障碍是常见的 然而，超过三分之一的美国成年人睡眠不足，但往往没有得到解决。这 该提案基于睡眠不足导致SDB患者嗜睡的前提， 可能解释了嗜睡和轻度SDB患者对PAP治疗反应的变异性。的 目的是确定对患者产生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）差异。我们将解决以下具体问题 具体目标1：证明认知行为睡眠时间延长（STE）的有效性 在提高客观警觉性方面与PAP相比。主要假设1是STE将是非- 在增加客观警觉性方面不如PAP治疗[心理警觉性测试（PVT）次数] 失效]。如果观察到STE优于PAP的迹象，我们将检验次要假设，即STE 在提高轻度SDB患者的客观警觉性方面上级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。初级 假设2是STE在减少日间嗜睡和疲劳方面不劣于PAP治疗。如果 如果观察到STE优于PAP的迹象，我们将检验STE将 在减轻轻度SDB患者白天嗜睡和疲劳方面，上级优于PAP。我们亦建议 探索性目的3：评价STE与PAP相比在改善内皮功能方面的有效性 和降低高血压患者亚组的血压。假设3A是 在高血压患者中，STE在降低血压方面不劣于PAP， 假设3B是，在高血压患者中，STE在改善血压方面不劣于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 这些目的是通过比较4个疗程的STE计划与PAP治疗（4个疗程的PAP依从性 程序）。我们还将包括一个4届非指令性平等注意睡眠教育“控制”（SEC） 程序. STE计划包括行为，认知和动机增强策略，以增加 睡眠时间将在治疗前和治疗后（1个月）以及3个月时再次测量关键结局 随访无论结果如何，结果都将产生重大影响。如果STE在改善 结果，轻度SDB患者应首先鼓励在开始治疗前获得充足的睡眠。 啪。如果STE为非劣效性，则任何一种治疗都可能是可行的，并且可以基于患者的偏好。 相反，PAP的优越性意味着对故障排除和提高接受度的实质性强调 坚持是必要的。