N/A
Completed N=190
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Obstructive Sleep Apnea · Central Sleep Apnea · Mixed Sleep Apnea · Cheyne-Stokes Respiration
Source: ClinicalTrials.gov NCT02034175 ↗
Enrolled (actual)
190
Serious AEs
0.0%
Results posted
Jan 2019
Primary outcomePrimary: Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI) — 87.1 percentage of device agreements
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement Between Polysomnography (PSG) and SomnaPatch in Detecting Patients Apnea-Hypopnea Index (AHI) |
87.1 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02034175). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.