Evaluation of a Neuromodulation Device For Rhinitis And Rhinosinusitis Symptoms
| Status: | Recruiting |
|---|---|
| Conditions: | Allergy, Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 10/3/2018 |
| Start Date: | September 21, 2018 |
| End Date: | September 21, 2019 |
| Contact: | Michael Gertner, MD |
| Email: | mgertner@oo-med.com |
| Phone: | 650-283-9388 |
Evaluation of an External Neuromodulation Device (iCLEAR) For the Acute Relief of Rhinitis and Rhinosinusitis Symptoms
The purpose of this study is to: (1) explore safety and potential efficacy of the iCLEAR
device in alleviating symptoms of chronic rhinitis and rhinosinusitis; (2) evaluate the
patient interface and other components of the device.
device in alleviating symptoms of chronic rhinitis and rhinosinusitis; (2) evaluate the
patient interface and other components of the device.
A single-arm longitudinal pilot study; there will be no change to subjects' standard of care.
The study device will be adjunctive to other prescribed therapy. Subjects will be asked to
use the study device for 30 days, beginning with 3 times daily for 2 weeks, followed by twice
daily and as needed for the remaining 2 weeks.
The study device will be adjunctive to other prescribed therapy. Subjects will be asked to
use the study device for 30 days, beginning with 3 times daily for 2 weeks, followed by twice
daily and as needed for the remaining 2 weeks.
Inclusion Criteria:
- Visual Analogue Scale > 25 mm, NOSE = 2 on any symptom except sleeping
Exclusion Criteria:
- Nasal Obstruction >50%
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