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Validation of Sleep Apnea Diagnosis Device

NCT03526133 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2019-09-30

No results posted yet for this study

Summary

Obstructive sleep apnea (OSA) is common and largely underdiagnosed disease. The standard method for the diagnosis of OSA is a complete night polysomnography (PSG). Simple methods for OSA diagnosis are necessary. The overnight oximetry with the oxygen desaturation index (ODI) has been largely investigated as a diagnostic test for OSA but its accuracy remains undefined. The aim of our study is to evaluate if an wireless polygraph (Oxistar) is accurate to diagnosis OSA in patients referred to a Sleep Lab.

Conditions

Interventions

DIAGNOSTIC_TEST

Polysomnography (PSG) and wireless sensor Oxistar

Monitoring the apnea-hypopnea index (AHI) derived from PSG and the oxygen desaturation index (ODI) obtained by the Oxistar.

Sponsors & Collaborators

  • Biologix Sistemas Ltda

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Geraldo Lorenzi-Filho, MD, PhD · Associate Professor

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-07
Primary Completion
2018-12-07
Completion
2019-02-07

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03526133 on ClinicalTrials.gov