Validation of the Stardust Cardio-Respiratory Recorder (Stardust)

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Brazil
  • SP
    • Sao Paulo, SP, Brazil, 04020-060
      • AFIP
    • São Paulo, SP, Brazil, 04024-002
      • AFIP

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Ambulatory patients with complains of OSA

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Associação Fundo de Incentivo à Pesquisa
• Collaborators: Philips Respironics
• Investigators: Study Director: Sergio Tufik, MD, PhD, Associacao Fundo de Incentivo a Psicofarmcologia

Study record dates

Study Major Dates

• Study Start: April 1, 2007
• Primary Completion (Actual): November 1, 2007
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: April 25, 2007
• First Submitted That Met QC Criteria: April 25, 2007
• First Posted (Estimate): April 27, 2007

Study Record Updates

• Last Update Posted (Estimate): July 12, 2012
• Last Update Submitted That Met QC Criteria: July 11, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: 0099/07