Status:
COMPLETED
Validation of the Stardust Cardio-Respiratory Recorder
Lead Sponsor:
Associação Fundo de Incentivo à Pesquisa
Collaborating Sponsors:
Philips Respironics
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
21-65 years
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 diagnosti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00466011
Start Date
April 1 2007
End Date
May 1 2008
Last Update
July 12 2012
Active Locations (2)
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1
AFIP
São Paulo, São Paulo, Brazil, 04020-060
2
AFIP
São Paulo, São Paulo, Brazil, 04024-002