Ignite Creation Date:
2024-05-05 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00466011
Status:
COMPLETED
Last Update Posted:
2012-07-12
First Post:
2007-04-25
Brief Title:
Validation of the Stardust Cardio-Respiratory Recorder
Sponsor:
Associação Fundo de Incentivo à Pesquisa
Organization:
Associação Fundo de Incentivo à Pesquisa
Study Overview
Official Title:
Validation of the Stardust Cardio-Respiratory Recorder
Status:
COMPLETED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Stardust
Brief 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 SDPSG 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 SDPSG lab AHI from PSG of PSGSD lab and AHI from PSG lab The analyses of SDs and PSGs recordings were performed by two blinded technicians
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None