Improving outcomes for patients with SDB and insufficient sleep
Improving outcomes for patients with SDB and insufficient sleep
批准号:
10488651
负责人:
M. Safwan Badr
金额:
$71.42万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-09-01 至 2024-07-31
关键词:
AddressAdherenceAdultAftercareApneaAttentionBehavioralBlood PressureBlood VesselsCardiovascular systemClinicalClinical TrialsCognitiveDrowsinessEducationEducational InterventionEffectivenessEndotheliumEpidemicFailureFatigueFutureGoalsHourHypertensionInflammatory ResponseInterventionLiteratureMeasuresMotivationOutcomePathway interactionsPatient PreferencesPatient-Focused OutcomesPatientsPeripheralSamplingSeveritiesSeverity of illnessSleepSleep Apnea SyndromesSleep DeprivationSleep DisordersSymptomsTestingTimeWorkadequate sleepadverse outcomealertnessarterial tonometrybasebehavioral adherenceblood pressure reductionblood pressure regulationcomparativeeffectiveness evaluationendothelial dysfunctionexperiencefollow-uphypertensiveimprovedimproved outcomeindexinginnovationmortalitypatient orientedpatient subsetspositive airway pressurepressureprogramsresponsesymptomatic improvementtherapy adherencetime usetreatment choicetrial designvigilance
中文摘要
嗜睡是睡眠中心的常见症状,睡眠呼吸障碍是常见的
原因:然而,超过三分之一的美国成年人睡眠不足,但并不经常得到解决。这
该提案的前提是睡眠不足会导致SDB患者的困倦,以及
可能解释了嗜睡和轻度SDB患者对PAP治疗反应的变异性。这个
目的是确定给患者带来最大益处的治疗方法。我们还将探索
高血压患者之间的血压差异(血压结果)。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,计划在提高客观警觉性方面具有优势。基本假设1是STE将不是
在提高客观警觉性方面不如PAP疗法[精神运动警觉测试(PVT)次数
失效]。如果观察到STE优于PAP的迹象,我们将检验STE的第二假设
在提高轻度SDB患者的客观警觉性方面优于PAP。具体目标2:
证明与PAP相比,STE在减少白天嗜睡和疲劳方面的有效性。主要
假设2 STE在减少日间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STE将是
PAP在减轻轻度SDB患者白天嗜睡和疲劳方面优于PAP。我们还提议
探索性目标3:评价STE与PAP在改善内皮功能方面的效果
以及降低高血压患者亚群中的血压。探索性假设3A是
在高血压患者中,STE的降压效果不亚于PAP,且具有探索性
假设3B是,在高血压患者中,STE的改善程度不亚于PAP
内皮功能。如果观察到STE优于PAP的迹象,我们将测试
在改善内皮功能、降低血压方面,STE优于PAP。我们将解决
这些目的是通过比较4个疗程的STE计划和PAP疗法(坚持4个疗程的PAP
计划)。我们还将包括一个为期4节的非指令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,以提高
睡眠时间。关键结果将在治疗前和治疗后(1个月)以及在3个月时再次评估
后续行动。无论结果如何,结果都将产生重大影响。如果STE在改善方面优于PAP
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
爸爸。如果STE是非劣质的,则任何一种治疗方法都可能是可行的,并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
而且坚持是有根据的。
英文摘要
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.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
ACHIEVE Investigator Development Core
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批准号:10437394
-
项目类别:
-
资助金额:$9.78万
-
财政年份:2021
-
负责人:M. Safwan Badr
-
依托单位:
ACHIEVE Investigator Development Core
-
批准号:10494189
-
项目类别:
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资助金额:$81.69万
-
财政年份:2021
-
负责人:M. Safwan Badr
-
依托单位:
ACHIEVE Investigator Development Core
-
批准号:10662509
-
项目类别:
-
资助金额:$8.43万
-
财政年份:2021
-
负责人:M. Safwan Badr
-
依托单位:
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
-
批准号:10578689
-
项目类别:
-
资助金额:$0.0万
-
财政年份:2020
-
负责人:M. Safwan Badr
-
依托单位:
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
-
批准号:10390291
-
项目类别:
-
资助金额:$0.0万
-
财政年份:2020
-
负责人:M. Safwan Badr
-
依托单位:
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
-
批准号:9889338
-
项目类别:
-
资助金额:$0.0万
-
财政年份:2020
-
负责人:M. Safwan Badr
-
依托单位:
Improving outcomes for patients with SDB and insufficient sleep
-
批准号:10689812
-
项目类别:
-
资助金额:$61.37万
-
财政年份:2019
-
负责人:M. Safwan Badr
-
依托单位:
Improving outcomes for patients with SDB and insufficient sleep
-
批准号:10241257
-
项目类别:
-
资助金额:$71.24万
-
财政年份:2019
-
负责人:M. Safwan Badr
-
依托单位:
Sleep-Disordered Breathing in patients with C-SCI: Mechanisms and Therapy
-
批准号:9331700
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项目类别:
-
资助金额:$29.95万
-
财政年份:2016
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负责人:M. Safwan Badr
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依托单位:
Sleep and Breathing in Patients With Spinal Cord Injury
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批准号:8967213
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项目类别:
-
资助金额:$0.0万
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财政年份:2014
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负责人:M. Safwan Badr
-
依托单位:
Sleep and Breathing in Patients With Spinal Cord Injury
-
批准号:8850249
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项目类别:
-
资助金额:$0.0万
-
财政年份:2014
-
负责人:M. Safwan Badr
-
依托单位:
Sleep and Breathing in Patients With Spinal Cord Injury
-
批准号:8736451
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项目类别:
-
资助金额:$0.0万
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财政年份:2014
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负责人:M. Safwan Badr
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依托单位:
Breathing Instability and Upper Airway Obstruction During Sleep: Effect of Aging
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批准号:7797917
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项目类别:
-
资助金额:$0.0万
-
财政年份:2009
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负责人:M. Safwan Badr
-
依托单位:
Breathing Instability and Upper Airway Obstruction During Sleep: Effect of Aging
-
批准号:7908856
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项目类别:
-
资助金额:$0.0万
-
财政年份:2009
-
负责人:M. Safwan Badr
-
依托单位:
Breathing Instability and Upper Airway Obstruction During Sleep: Effect of Aging
-
批准号:8195969
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项目类别:
-
资助金额:$0.0万
-
财政年份:2009
-
负责人:M. Safwan Badr
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依托单位:
Breathing Instability and Upper Airway Obstruction During Sleep: Effect of Aging
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批准号:8392946
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项目类别:
-
资助金额:$0.0万
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财政年份:2009
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负责人:M. Safwan Badr
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依托单位:
SLEEP APNEA--DETERMINANTS AND CONSEQUENCES
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批准号:6615786
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项目类别:
-
资助金额:$7.24万
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财政年份:1999
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负责人:M. Safwan Badr
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依托单位:
Sleep Apnea: Determinants and Consequences
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批准号:6824148
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项目类别:
-
资助金额:$8.16万
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财政年份:1999
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负责人:M. Safwan Badr
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依托单位:
Sleep Apnea: Determinants and Consequences
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批准号:7413726
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项目类别:
-
资助金额:$9.19万
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财政年份:1999
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负责人:M. Safwan Badr
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依托单位:
Sleep Apnea: Determinants and Consequences
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批准号:6920735
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项目类别:
-
资助金额:$8.41万
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财政年份:1999
-
负责人:M. Safwan Badr
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依托单位:
海外基金