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:10241257
- 负责人:
- 金额:$ 71.24万
- 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
- 起止时间:2019-09-01 至 2024-07-31
- 项目状态:已结题
- 来源:
- 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-upimprovedimproved outcomeindexinginnovationmortalitypatient orientedpatient subsetspressureprogramsresponsesymptomatic improvementtherapy adherencetime usetreatment choicetrial designvigilance
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.
困倦是睡眠中心常见的主诉,睡眠呼吸障碍也是常见的
项目成果
期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)
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M. Safwan Badr其他文献
M. Safwan Badr的其他文献
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{{ truncateString('M. Safwan Badr', 18)}}的其他基金
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
中枢性睡眠呼吸暂停:指导治疗的生理机制
- 批准号:
10578689 - 财政年份:2020
- 资助金额:
$ 71.24万 - 项目类别:
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
中枢性睡眠呼吸暂停:指导治疗的生理机制
- 批准号:
10390291 - 财政年份:2020
- 资助金额:
$ 71.24万 - 项目类别:
Central Sleep Apnea: Physiologic Mechanisms to Inform Treatment
中枢性睡眠呼吸暂停:指导治疗的生理机制
- 批准号:
9889338 - 财政年份:2020
- 资助金额:
$ 71.24万 - 项目类别:
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 - 财政年份:2019
- 资助金额:
$ 71.24万 - 项目类别:
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:
10689812 - 财政年份:2019
- 资助金额:
$ 71.24万 - 项目类别:
Sleep-Disordered Breathing in patients with C-SCI: Mechanisms and Therapy
C-SCI 患者的睡眠呼吸障碍:机制和治疗
- 批准号:
9331700 - 财政年份:2016
- 资助金额:
$ 71.24万 - 项目类别:
Sleep and Breathing in Patients With Spinal Cord Injury
脊髓损伤患者的睡眠和呼吸
- 批准号:
8967213 - 财政年份:2014
- 资助金额:
$ 71.24万 - 项目类别:
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