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临床试验/NCT01455077
NCT01455077Unknown不适用

Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity

Associacao Fundo de Incentivo a Psicofarmcologia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1

研究概览

简要总结

Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities.

However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population.

Objective:

To evaluate the accuracy of level III type of PMS - Stardust™" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA.

Methods:Participants with BMI > 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings:

  1. STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • BMI > 35
  • Complaints of snoring, sleep apnea, daytime sleepiness

排除标准

  • use of home oxygen
  • other sleep diseases
  • inability to perform PSG

研究者

发起方
Associacao Fundo de Incentivo a Psicofarmcologia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Lia Azeredo-Bittencourt

MD, PhD, associate professor

Associacao Fundo de Incentivo a Psicofarmcologia

研究点 (1)

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