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Validation of the Stardust Cardio-Respiratory Recorder

Validation of the Stardust Cardio-Respiratory Recorder

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00466011
Acronym
Stardust
Enrollment
80
Registered
2007-04-27
Start date
2007-04-30
Completion date
2008-05-31
Last updated
2012-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

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.

Interventions

None listed

Sponsors

Philips Respironics
CollaboratorINDUSTRY
Associação Fundo de Incentivo à Pesquisa
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes

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.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026