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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
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Further study details as provided by 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

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 25, 2007
Last Updated: July 11, 2012
Health Authority: Brazil: National Committee of Ethics in Research

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

ClinicalTrials.gov processed this record on May 21, 2013