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中文摘要
翻译
这个子项目是许多研究子项目中的一个 由NIH/NCRR资助的中心赠款提供的资源。子项目及 研究者(PI)可能从另一个NIH来源获得了主要资金, 因此可以在其他CRISP条目中表示。所列机构为 研究中心,而研究中心不一定是研究者所在的机构。 本研究的假设是,持续气道正压通气(CPAP)将改变身体器官水平的症状,如睡眠呼吸暂停和高血压的水平,这将导致白天嗜睡减少和白天功能改善。 主要目的是进行一项双盲、安慰剂随机对照研究,以评估CPAP对轻度阻塞性睡眠呼吸暂停(OSA)(水平<30)患者的功能改善效果。 次要目的是记录主观和客观日间嗜睡和24小时平均血压的降低。 受试者将接受为期8周的真实的CPAP或无PAP的CPAP治疗。 接受初始假治疗的患者将交叉至CPAP治疗。 入组者将在8周的开始和结束时完成睡眠功能结局问卷(FOSQ)、嗜睡主观测试(ESS)、精神警觉性测试(PVT)和埃普沃思嗜睡量表(ESS)。 24-还将在这些时间进行小时血压监测。 将保留日记。 虽然CPAP已被证明可以改善严重OSA的功能,但关于其对不太严重的疾病的影响的数据一直存在争议,并且在选择适当的对照组时存在方法缺陷。 研究者将使用一种新器械,该器械可有效地作为CPAP的对照,并且使用安全。本研究是一项多中心试验。
英文摘要
This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The hypothesis of this study is that continuous positive airway pressure (CPAP) will change body organ level symptoms such as the level of sleep apnea and hypertension, which will lead to a decrease in daytime sleepiness and improved daytime functioning. The primary aim is to conduct a double-blind, placebo randomized controlled study of the functional improvement efficacy of CPAP in those with less severe obstructive sleep apnea (OSA) (levels <30). The secondary aims are to document the reduction in subjective and objective daytime sleepiness and in 24-hour mean blood pressure. Subjects will undergo 8 weeks of either real CPAP or CPAP without the PAP. Those on initial sham treatment will crossover to CPAP. Enrollees will complete the Functional Outcome of Sleep Questionnaire (FOSQ), Subjective Test of Sleepiness (ESS), Psychomotor Vigilance Test (PVT), and Epworth Sleepiness Scale (ESS) at the beginning and at the end of 8 weeks. 24-hour blood-pressure monitoring will also be performed at these times. Diaries will be kept. Although CPAP has been shown to improve function in severe OSA, the data regarding its effect on less severe disease has been controversial and the methods flawed in the selection of a proper control group. The investigators will use a new device that effectively serves as a control for CPAP and is safe for use. This study is a multi-center trial.
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IMPACT OF CPAP ON FUNCTIONAL OUTCOMES IN MILDER OSA
IMPACT OF CPAP ON FUNCTIONAL OUTCOMES IN MILDER OSA
SKIN TEMPERATURE CHANGES TO DETECT SLEEP ONSET IN UNMONITORED SLEEP STUDIES
Comparison of Minimal to Full Polysomnography for the Diagnosis of OSAHS