Chronic Rhinitis, Non-allergic Rhinitis
Conditions
Keywords
Radiofrequency ablation, Cryotherapy, Chronic rhinitis
Brief summary
The goal of this clinical trial is to learn which procedural intervention most effectively reduces symptoms of chronic rhinitis (non-allergic rhinitis) in adult patients (18 years and older). The main questions it aims to answer are: * Which procedural intervention leads to the greatest reduction in total nasal symptom scores (TNSS)? * Which procedural intervention leads to the greatest improvement in sinonasal quality of life as measured by the SNOT-22? Researchers will compare radiofrequency ablation (RhinAer or Neuromark) and cryotherapy (ClariFix) to see if there are differences in symptom reduction and durability of response across treatments. Participants will: * Be randomly assigned to one of three FDA-cleared posterior nasal nerve ablation procedures (RhinAer, Neuromark, or ClariFix) * Complete validated symptom questionnaires (TNSS and SNOT-22) before and after their procedure * Have their relevant medical records reviewed (demographics, clinical history, prior rhinitis treatments)
Detailed description
Chronic rhinitis (non-allergic/vasomotor rhinitis) affects an estimated 14 million Americans and is characterized by nasal inflammation in the absence of infectious or allergic triggers. When medical management fails, patients may pursue procedural intervention to ablate the posterior nasal nerves. Currently available FDA-cleared standard-of-care options include in-office radiofrequency ablation (RhinAer, Neuromark) and cryotherapy (ClariFix). Despite the availability of these modalities, comparative effectiveness data are lacking. This randomized controlled trial will enroll adult patients and randomly assign them to one of the three treatment arms to compare symptom reduction and durability of response across the three procedures.
Interventions
DEVICERhinAer
RhinAer is an in-office radiofrequency ablation device that delivers targeted thermal energy to the posterior nasal nerve along the lateral nasal wall. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.
DEVICENeuromark
Neuromark is an in-office radiofrequency ablation device that delivers targeted thermal energy to the posterior nasal nerve along the lateral nasal wall. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.
DEVICEClarifix
ClariFix is an in-office cryoablation device that applies freezing (cold thermal) energy to the posterior nasal nerve in the posterior nasal cavity. The procedure is performed under local anesthesia without the need for general anesthesia or sedation, and aims to reduce parasympathetic nerve signaling to decrease rhinorrhea, postnasal drip, and nasal congestion in patients with chronic rhinitis.
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Diagnosis of chronic rhinitis (non-allergic rhinitis)
Exclusion criteria
\- Under 18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sino-Nasal Outcome Test-22 (SNOT-22) | SNOT-22 will be administered at baseline and at 1, 3, and 6 months post-procedure. | SNOT-22 is a validated 22-item patient-reported outcome measure assessing sinonasal-specific quality of life across domains including nasal symptoms (nasal blockage, rhinorrhea, loss of smell/taste), ear and facial symptoms (ear pain, facial pressure), sleep dysfunction (difficulty falling asleep, waking up tired), and psychological and functional impairment (reduced productivity, fatigue, sadness). |
| Total Nasal Symptom Score (TNSS) | TNSS will be administered at baseline and at 1, 3, and 6 months post-procedure. | TNSS is a validated 4-item patient-reported scoring instrument measuring severity of rhinorrhea, nasal congestion, nasal itching, and sneezing. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Patient Satisfaction | VAS patient satisfaction will be administered at 1, 3, and 6 months post-procedure. | A 0-10 visual analog scale on which patients rate their overall satisfaction with the procedure and its effect on their chronic rhinitis symptoms, with higher scores indicating greater satisfaction. |
Countries
United States
Outcome results
None listed