Validation of the Stardust Cardio-Respiratory Recorder

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT00466011
• Lead Sponsor: Associação Fundo de Incentivo à Pesquisa

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 (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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-25
• Study First Submitted QC: 2007-04-25
• Study First Posted: 2007-04-27
• Primary Completion: 2007-11
• Study Completion: 2008-05
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-11
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patient referred to Sleep Disorder Center because of:

  • Excessive daytime sleepiness,
  • Loud snoring,
  • Witnessed apnea.

• Patient with ability to provide consent, ability and willingness to follow study procedures.

Exclusion Criteria

• Suspicion of insomnia,
• Restless leg syndrome,
• Periodic limb movements; or
• Other non-OSA sleep disorders.
• Patient experiencing acute illness, patients who are medically complex, and patients requiring supplemental oxygen or mechanical ventilation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

AFIP; 🇧🇷 São Paulo, SP, Brazil