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Validation of the Stardust Cardio-Respiratory Recorder — Stardust  

Obstructive Sleep Apnea Clinical Trial

Official title:
Validation of the Stardust Cardio-Respiratory Recorder

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00466011
Study type Observational
Source Associação Fundo de Incentivo à Pesquisa
Contact
Status Completed
Phase N/A
Start date April 2007
Completion date May 2008
View Details
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