Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Somnarus

Status: Completed

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

Treatments: Device: Polysomnography; Device: SomnaPatch

Study type: Interventional

Funder types: Industry

Identifiers

NCT02034175

SomnaPatch-001-D

Details and patient eligibility

About

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).

Full 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.

Enrollment: 190 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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190 participants in 2 patient groups

SomnaPatch

Experimental group

Description:

SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.

Treatment:

Device: SomnaPatch

Polysomnography

Active Comparator group

Description:

Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.

Treatment:

Device: Polysomnography