Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients
Recruitment status was Recruiting
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.
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.
Obstructive Sleep Apnea Syndrome
|Study Design:||Observational Model: Ecologic or Community
Time Perspective: Prospective
|Official Title:||Validation of a Portable Monitoring System for the Diagnosis of Obstructive Sleep Apnea Syndrome in Patients With Level II and III Obesity|
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||January 2012|
|Primary Completion Date:||July 2011 (Final data collection date for primary outcome measure)|
BMI > 35
Please refer to this study by its ClinicalTrials.gov identifier: NCT01455077
|Contact: Lia R Bittencourt, MD, PhD||55 11 firstname.lastname@example.org|
|Associacao Fundo de Incentivo a Psicofarmacologia||Recruiting|
|São Paulo, SP, Brazil|
|Contact: Lia R Bittencourt, MD, PhD 55 11 21490155 email@example.com|
|Contact: Erika C Treptow firstname.lastname@example.org|
|Sub-Investigator: Erika C Treptow|