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Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Obstructive Sleep Apnea Clinical Trial

Official title:
Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing

Clinical Trial Summary

The purpose of this study is to evaluate the accuracy of Somnarus diagnostic technology for diagnosis of sleep apnea in human subjects. This includes evaluation of Somnarus technology in Obstructive Sleep Apnea (OSA) and Central Sleep Apnea (CSA), including Cheyne - Stokes respiration (CSR).

Clinical Trial Description

This is a multi- center, open label study to evaluate the accuracy of Somnarus device when compared with overnight polysomnographic measurements.

The study includes the following steps:

Screening the database or advertising among cardiologists, neurologists, pulmonologists and Ear Nose and Throat (ENT) specialists to identify potential subjects.

Initial visit, includes:

1. Consent discussion and signature

2. History, vital signs, and physical exam

Night study

a. A polysomnogram is conducted and, at the same time, a SomnaPatch device is used.

Additional visits If side effects occur, or if the data collection fails, or at the request of the sponsor to repeat the sleep study for further data collection and comparison. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02034175
Study type Interventional
Source Somnarus Inc
Contact
Status Completed
Phase N/A
Start date February 1, 2016
Completion date November 30, 2016
View Details
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