Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Study Overview
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Brief Summary
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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
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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: Consent discussion and signature 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.

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

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

Intervention / Treatment
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* Device: SomnaPatch
* Device: Polysomnography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able to understand and sign the informed consent Able to comply with visits and follow ups included in this protocol Ages 20-85 years 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SomnaPatch<br>SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. | Device: SomnaPatch<br>* SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.<br>|
| Active Comparator: Polysomnography<br>Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. | Device: Polysomnography<br>* Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI) | 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 | 1 night | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cheyne, apnea, hypopnea, polysomnography, respiratory