Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-01

Study Completion Date

2016-11-30

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).

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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:

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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

The two sets of data (PSG and Somnapatch) were scored independently. Therefore it was masked what set of data belonged to what individual.

Study Groups

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SomnaPatch

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

Group Type EXPERIMENTAL

SomnaPatch

Intervention Type DEVICE

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

Polysomnography

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

Group Type ACTIVE_COMPARATOR

Polysomnography

Intervention Type DEVICE

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

Interventions

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SomnaPatch

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

Intervention Type DEVICE

Polysomnography

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

Intervention Type DEVICE

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No