Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Not Applicable

Completed

Conditions: Mixed Sleep Apnea
Cheyne-Stokes Respiration
Obstructive Sleep Apnea
Central Sleep Apnea

Brief 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).

Detailed 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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

An unstable medical condition, acute or chronic, that in the opinion of the investigator puts the subject at health risks related this trial or interferes with the clinical trial and data collection.
Skin rash on the nose or on the maxillary area.
A history of skin allergy to medical tape, and hypoallergenic tapes.
A history of skin cancer on the nose or on the maxillary area.
A history of the base of skull fractures, facial fractures

Primary Outcome Measures

Name	Time	Method
Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)	1 night	AHI is the number of apneas and hypopneas that occur over an hour during the course of the night. The SomnaPatch and PSG were wore simultaneously over the night. The results from the SomnaPatch and PSG were compared per individual for agreement

Secondary Outcome Measures

Name	Time	Method

Locations (3): 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
Preferred Research Partners, Inc
🇺🇸Little Rock, Arkansas, United States