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Validation of the Stardust Cardio-Respiratory Recorder (Stardust)

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ClinicalTrials.gov Identifier: NCT00466011
Recruitment Status : Completed
First Posted : April 27, 2007
Last Update Posted : July 12, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 Design

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


Outcome Measures

Eligibility Criteria

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 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
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases