Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02034175
• Other study ID #: SomnaPatch-001-D
• Status: Completed
• Phase: N/A
• Start date: February 1, 2016
• Est. completion date: November 30, 2016

Study information

• Verified date: September 2019
• Source: Somnarus Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: November 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Central Sleep Apnea
• Cheyne-Stokes Respiration
• Mixed Sleep Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Central
• Sleep Apnea, Obstructive

Intervention

Device:
• SomnaPatch
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.

Locations

Country	Name	City	State
United States	Peninsula Sleep Center	Burlingame	California
United States	Preferred Research Partners, Inc	Little Rock	Arkansas
United States	The Good Sheperd Sleep Center, LLC	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Somnarus Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)	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