Validation of the Stardust Cardio-Respiratory Recorder

This study has been completed.
Sponsor:
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier:
NCT00466011
First received: April 25, 2007
Last updated: July 11, 2012
Last verified: July 2012

April 25, 2007
July 11, 2012
April 2007
November 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00466011 on ClinicalTrials.gov Archive Site
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Validation of the Stardust Cardio-Respiratory Recorder
Validation of the Stardust Cardio-Respiratory Recorder

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.

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Observational
Time Perspective: Prospective
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Non-Probability Sample

Ambulatory patients with complains of OSA

Obstructive Sleep Apnea
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
May 2008
November 2007   (final data collection date for primary outcome measure)

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.
Both
21 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00466011
0099/07
Yes
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
Associação Fundo de Incentivo à Pesquisa
Philips Respironics
Study Director: Sergio Tufik, MD, PhD Associacao Fundo de Incentivo a Psicofarmcologia
Associação Fundo de Incentivo à Pesquisa
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP