Validation of the Stardust Cardio-Respiratory Recorder

Obstructive Sleep Apnea Clinical Trial

— Stardust  

Official title:

Validation of the Stardust Cardio-Respiratory Recorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00466011
• Other study ID #: 0099/07
• Status: Completed
• Phase: N/A
• First received: April 25, 2007
• Last updated: July 11, 2012
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: July 2012
• Source: Associação Fundo de Incentivo à Pesquisa
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: May 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 65 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Brazil	AFIP	Sao Paulo	SP
Brazil	AFIP	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Associação Fundo de Incentivo à Pesquisa	Philips Respironics

Country where clinical trial is conducted

Brazil,