Validation of the Stardust Cardio-Respiratory Recorder

A

Associação Fundo de Incentivo à Pesquisa

Status

Completed

Conditions

Obstructive Sleep Apnea

Study type

Observational

Funder types

Other
Industry

Identifiers

NCT00466011
0099/07

Details and patient eligibility

About

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.

Enrollment

80 patients

Sex

All

Ages

21 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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