At a glance

ClinicalIndex Comparison Record

N/ACompleted· 190 enrolled

Drug / intervention

SomnaPatch +1 moredevice

Likely dose

Not stated in record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02034175

NCT02034175N/ACompleted

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

Somnarus Inc·interventional·Posted Jan 13, 2014·Updated Oct 3, 2019

In Brief

A clinical study evaluating SomnaPatch and Polysomnography for Obstructive Sleep Apnea and 3 related conditions. Completed, enrolled 190 participants across 3 sites.

Detailed 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).

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsObstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration

CountriesUnited States

Collaborators--

Timeline

N/ACompletedFinished

2014201520162017201820192020202120222023202420252026

First PostedJan 2014

Enrollment StartFeb 2016

Primary CompletionNov 2016

TodayJul 2026

First PostedJan 13, 2014

Enrollment StartFeb 1, 2016

Primary CompletionNov 30, 2016

TodayJul 2, 2026

Enrollment to primary: 10 monthsPosted 12.5 years ago

Interventions

SomnaPatchdevice

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

Polysomnographydevice

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