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Clinical Evaluation of an Apnea Index for Diagnosis and Screening of Obstructive Sleep Apnea (OSA)

NCT01010438 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 59

Last updated 2016-11-02

No results posted yet for this study

Summary

The study is designed to compare the apnea event recognition capability of the Capnostream 20 with investigational software to polysomnograph recordings scored by a trained analyst. The study will compare the apnea index score (AI) calculated by the Capnostream 20 algorithm based on capnography to that calculated by a trained analyst evaluating polysomnograph recordings.

To this aim, subjects will be connected to EMBLA N7000 Polysomnograph, and to the Capnostream 20, in order to monitor CO2 and SpO2 during routine overnight sleep studies.

The Capnostream, using both its USB Data Port and Analog output port will simultaneously provide the monitored data both to a USB flash memory device and Polysomnograph for storage for future analysis.

The data collected by the Polysomnograph including the Capnostream data will be analyzed by a trained expert for evaluation of apnea events obtained from both sources.

In parallel, the Capnostream data as collected with the USB flash memory, will be downloaded onto a PC, and using the Oridion software algorithm designed for evaluating the data (to be implemented in the monitor when validated), the Apnea Index and Oxygen Desaturation Index will be calculated. The results of the Apnea Index scores calculated from the Polysomnograph and from the DUT will be compared.

Based on the results, the study will then evaluate the ability of the Capnograph/Pulse-Oximeter as a tool for screening and assisting in the diagnosis of patients with obstructive sleep-apnea in the hospital environment, where it is being used as a ventilation monitor based on the demonstration of a high correlation with the gold standard in the sleep lab.

Conditions

Sponsors & Collaborators

  • Oridion

    lead INDUSTRY

Principal Investigators

  • Giora Pillar, MD · Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit, Rambam Health Care Campus

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2011-07-31
Completion
2011-12-31

Countries

  • Israel

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 NCT01010438 on ClinicalTrials.gov