Validation of the Stardust Cardio-Respiratory Recorder (Stardust)

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. Identifier: NCT00466011
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : July 12, 2012
Philips Respironics
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, 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.

Condition or disease
Obstructive Sleep Apnea

Study Type : Observational
Actual Enrollment : 80 participants
Time Perspective: Prospective
Official Title: Validation of the Stardust Cardio-Respiratory Recorder
Study Start Date : April 2007
Actual Primary Completion Date : November 2007
Actual Study Completion Date : May 2008

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U.S. FDA Resources

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

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.

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 identifier (NCT number): NCT00466011

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

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

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