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Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
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).
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.
Age
20 - 85 years
Sex
ALL
Healthy Volunteers
No
Preferred Research Partners, Inc
Little Rock, Arkansas, United States
Peninsula Sleep Center
Burlingame, California, United States
The Good Sheperd Sleep Center, LLC
Tampa, Florida, United States
Start Date
February 1, 2016
Primary Completion Date
November 30, 2016
Completion Date
November 30, 2016
Last Updated
October 3, 2019
190
ACTUAL participants
SomnaPatch
DEVICE
Polysomnography
DEVICE
Lead Sponsor
Somnarus Inc
NCT06430957
NCT07292922
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07225686