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

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT01010438
• Lead Sponsor: Oridion

Brief 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.

Detailed Description

The clinical investigation will be conducted until enrollment of at least 30 adult and 30 Pediatric patients of both sexes with complete data sets are collected from three different sleep lab sites per the FDA guidance requirements. The enrollment time will last up to six (6) months. The overall number of enrolled patients (i.e. with complete/incomplete data) will not exceed 80 patients.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-11-08
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2011-07
• Study Completion: 2011-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

• All Adults > 18 years old and able to understand and give consent per the IRB or a child above one years old consented by a parent or legal guardians.
• Patients consented or for whom legal guardians consented for the participation of this trial.
• Patient recommended for a Sleep assessment by medical staff.

Exclusion Criteria

• Patients who in the opinion of the investigator should not participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of apnea event detection	Apnea events are defined as events that last at least 10 seconds

Secondary Outcome Measures

Name	Time	Method
Validation of apnea index	Post study analysis

Trial Locations

Locations (3)

Hillel Yaffe Sleep Lab Center; 🇮🇱 Hadera, Israel

Prof. Giora Pillar M.D., Deputy Director, Department of Pediatrics, Director, Pediatric Sleep Disorders Unit; 🇮🇱 Haifa, Israel

Hadassah Sleep Lab Center; 🇮🇱 Jerusalem, Israel