Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

September 19, 2019 updated by: Somnarus Inc

Comparison of the Somnarus Sleep Apnea Diagnostic Technology 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc
    • California
      • Burlingame, California, United States, 94010
        • Peninsula Sleep Center
    • Florida
      • Tampa, Florida, United States, 33635
        • The Good Sheperd Sleep Center, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SomnaPatch
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
Device: SomnaPatch
SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
ACTIVE_COMPARATOR: Polysomnography
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
Device: Polysomnography
Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)
Time Frame: 1 night
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
1 night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Somnarus Inc

Investigators

  • Principal Investigator: Merhan Farid-Moayer, MD, Peninsula Sleep Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2016

Primary Completion (ACTUAL)

November 30, 2016

Study Completion (ACTUAL)

November 30, 2016

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 13, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 3, 2019

Last Update Submitted That Met QC Criteria

September 19, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SomnaPatch-001-D

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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