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Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

NCT02034175 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 190

Last updated 2019-10-03

Study results available
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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).

Conditions

Interventions

DEVICE

SomnaPatch

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

DEVICE

Polysomnography

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

Sponsors & Collaborators

  • Somnarus Inc

    lead INDUSTRY

Principal Investigators

  • Merhan Farid-Moayer, MD · Peninsula Sleep Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-01
Primary Completion
2016-11-30
Completion
2016-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02034175 on ClinicalTrials.gov