CompletedNot Applicable

Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing

United States190 participantsStarted 2016-02-01

Plain-language 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).

Who can participate

Age range20 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI)

Timeframe: 1 night

Trial details

NCT IDNCT02034175

SponsorSomnarus Inc

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-11-30

Results submitted2018-07-25

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials