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Validation of the Stardust Cardio-Respiratory Recorder (Stardust)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00466011
First Posted: April 27, 2007
Last Update Posted: July 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Philips Respironics
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa
  Purpose
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.

Condition
Obstructive Sleep Apnea

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Validation of the Stardust Cardio-Respiratory Recorder

Further study details as provided by Prof. Dr. Lia Azeredo-Bittencourt, Associação Fundo de Incentivo à Pesquisa:

Enrollment: 80
Study Start Date: April 2007
Study Completion Date: May 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory patients with complains of OSA
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00466011


Locations
Brazil
AFIP
Sao Paulo, SP, Brazil, 04020-060
AFIP
São Paulo, SP, Brazil, 04024-002
Sponsors and Collaborators
Associação Fundo de Incentivo à Pesquisa
Philips Respironics
Investigators
Study Director: Sergio Tufik, MD, PhD Associacao Fundo de Incentivo a Psicofarmcologia
  More Information

Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, Prof. Dr., Associação Fundo de Incentivo à Pesquisa
ClinicalTrials.gov Identifier: NCT00466011     History of Changes
Other Study ID Numbers: 0099/07
First Submitted: April 25, 2007
First Posted: April 27, 2007
Last Update Posted: July 12, 2012
Last Verified: July 2012

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases