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NCT02034175 · ClinicalTrials.gov registry record · NA

Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

A NA study of Obstructive Sleep Apnea and Central Sleep Apnea, sponsored by Somnarus.

Completed
Registry status
NA
Development phase
190
Enrollment target
3
Study locations

NCT02034175: Completed NA study of Obstructive Sleep Apnea and Central Sleep Apnea, sponsored by Somnarus.

NCT02034175 is a NA study of Obstructive Sleep Apnea and Central Sleep Apnea that has completed, run by Somnarus. The registered enrollment target is 190 participants, below the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (14% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02034175, a NA study of Obstructive Sleep Apnea and Central Sleep Apnea, has completed, sponsored by Somnarus.

COMPLETED
Registry status
NA
Development phase
190 participants
Enrollment target
3
Study locations

Study 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).

Primary Outcome

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

Interventions

  • DEVICE Polysomnography
  • DEVICE SomnaPatch

Study Locations (3)

Arkansas

  • Preferred Research Partners, Inc - Little Rock

California

  • Peninsula Sleep Center - Burlingame

Florida

  • The Good Sheperd Sleep Center, LLC - Tampa

Trial Details

FieldValue
Enrollment Target 190 participants
Start Date 2016-02-01
Est. Completion 2016-11-30
Phase NA
Somnarus

1 total trials

What the finished NCT02034175 record still lists

NCT02034175 is an interventional study that assigns participants to a tested intervention. The registered 190 participants enrollment target is mid-sized for trials with a published cap, below the 220-participant average among 155 other Obstructive Sleep Apnea trials with a reported enrollment target (14% lower).

The record links to 4 conditions, with Obstructive Sleep Apnea appearing as the primary indexed condition, and to 2 interventions - of which Polysomnography is the first listed.

NCT02034175 reports a single indexed study location in Arkansas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT02034175 about?

NCT02034175 is a clinical study titled "Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing". 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).

What is the current status of trial NCT02034175?

This trial is currently completed. It is a NA study. The enrollment target is 190 participants. The study started on 2016-02-01. Estimated completion is 2016-11-30.

What conditions does trial NCT02034175 study?

This clinical trial studies the following conditions: Obstructive Sleep Apnea, Central Sleep Apnea, Cheyne-Stokes Respiration, Mixed Sleep Apnea.

What interventions are being tested in trial NCT02034175?

The interventions under investigation include: Polysomnography (DEVICE), SomnaPatch (DEVICE).

Who is sponsoring clinical trial NCT02034175?

This trial is sponsored by Somnarus, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02034175 being conducted?

This trial has 3 study locations across Arkansas, California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Obstructive Sleep Apnea

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02034175's enrollment target sits among peer trials

190 45th of 155 higher than 111 of 155 other Obstructive Sleep Apnea trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Obstructive Sleep Apnea trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02034175, the US trial registry maintained by the National Library of Medicine. NCT02034175 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.