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Validation of the Stardust Cardio-Respiratory Recorder

NCT ID: NCT00466011

Last Updated: 2012-07-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Philips Respironics

INDUSTRY

Sponsor Role collaborator

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Lia Azeredo-Bittencourt

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sergio Tufik, MD, PhD

Role: STUDY_DIRECTOR

Associacao Fundo de Incentivo a Psicofarmcologia

Locations

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AFIP

São Paulo, São Paulo, Brazil

Site Status

AFIP

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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0099/07

Identifier Type: -

Identifier Source: org_study_id