An observational study in Obstructive Sleep Apnea, sponsored by Associação Fundo de Incentivo à Pesquisa. Completed at 2 sites in Brazil. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-07-12.
Sponsored by Associação Fundo de Incentivo à Pesquisa · Observational
Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with clinical suspicion of OSA were selected. Three-order randomized evaluations had been performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded technicians.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's enrollment of 80 is below the median of 105 across 666 observational studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Associação Fundo de Incentivo à Pesquisa is the lead sponsor of 23 studies on the registry; 1 is open to participants now.
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Ambulatory patients with complains of OSA
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Patient referred to Sleep Disorder Center because of:
Exclusion Criteria:
The record gives a start of Apr 2007, a primary completion of Nov 2007 and a completion of May 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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Associação Fundo de Incentivo à Pesquisa