Obesity Clinical Trial
Official title:
Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity
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.
n/a
Observational Model: Ecologic or Community, Time Perspective: Prospective
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