Trials / Completed
CompletedNCT02034175
Comparison of SomnaPatch With Polysomnography in Sleep Disordered Breathing
Comparison of the Somnarus Sleep Apnea Diagnostic Technology SomnaPatch With Polysomnography in Sleep Disordered Breathing
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 190 (actual)
- Sponsor
- Somnarus Inc · Industry
- Sex
- All
- Age
- 20 Years – 85 Years
- Healthy volunteers
- Not accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SomnaPatch | SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face. |
| DEVICE | Polysomnography | Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders. |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2016-11-30
- Completion
- 2016-11-30
- First posted
- 2014-01-13
- Last updated
- 2019-10-03
- Results posted
- 2019-01-18
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02034175. Inclusion in this directory is not an endorsement.