Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

Completed · Not applicable

Conditions studied: Obstructive Sleep Apnea, Central Sleep Apnea, Mixed Sleep Apnea, Cheyne-Stokes Respiration

In brief

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).

Key facts

Study ID

NCT02034175

Run by

Somnarus Inc

People needed

190

Starts

2016-02-01

Expected to finish

2016-11-30

Last updated by the study team

2019-10-03

Who can join

Age: 20 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Able to understand and sign the informed consent
• Able to comply with visits and follow ups included in this protocol
• Ages 20-85 years

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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