Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity
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:
- 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
- 是
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
Prof. Dr. Lia Azeredo-Bittencourt
MD, PhD, associate professor
Associacao Fundo de Incentivo a Psicofarmcologia
