Heat therapy zaps nasal nerves to ease stuffy nose
NCT ID NCT06599736
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a procedure called RhinAer that uses heat to treat the nerves in the nose for people with chronic rhinitis (long-term stuffy or runny nose). Researchers want to see if it reduces inflammation and improves symptoms like cough and post-nasal drip. About 25 adults aged 22 to 85 with at least 12 months of rhinitis are taking part.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Mar 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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22 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 22 to 85 years (inclusively). 2. Willing and able to provide informed consent. 3. Willing and able to comply with the patient-specific requirements outlined in the study protocol. 4. Presenting to the ENT office seeking evaluation and/or treatment for chronic rhinitis (allergic or nonallergic) of at least 12 months duration 5. Willing to undergo the RhinAer procedure 6. Has a baseline rTNSS symptom score of ≥6 at time of screening 7. If on anticoagulation therapy, anticoagulant medications can be withheld during the perioperative period (at least 3-day window pre- and post-procedure). 8. Has been diagnosed with either allergic or non-allergic chronic rhinitis and meet the following criteria: * a. Allergic rhinitis: diagnosed with perennial (non-seasonal) allergic rhinitis and has demonstrated sensitization to specific allergens through skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the allergic nature of their rhinitis within the past 24 months. OR -b. Nonallergic rhinitis: diagnosed with nonallergic rhinitis with demonstration of a negative skin prick testing, specific IgE blood testing, or other allergy testing methods, confirming the nonallergic nature of their rhinitis within the past 24 months. Exclusion Criteria: 1. Anatomic obstructions in the nasal passage(s) that in the investigator's opinion limits access to the posterior nasal nerve treatment area. 2. Has seasonal rhinitis symptoms. 3. Current or recent use of biologic therapy within past 3 months. 4. History of chronic epistaxis or has had episodes of significant nose bleeds in the past 3 months. 5. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure. 6. Known or suspected to be pregnant or is lactating. 7. Has any condition resulting in a predisposition to excessive bleeding (e.g., hereditary hemorrhagic telangiectasia \[HHT\]). 8. Has diagnosis of rhinitis medicamentosa, an active nasal or sinus infection or has a history of 'dry eye.' 9. Has had previous procedure or surgery for chronic rhinitis (e.g., PNN ablation). 10. Has had a nasal or sinus surgical procedure in the past six (6) months. 11. Currently participating in another clinical research study or has participated in an interventional study within the past 3 months. 12. Has a planned adjunctive procedure at the time of the study procedure or within the 6-month study follow-up period 13. Other medical conditions which in the opinion of the investigator would predispose the patient to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Colorado ENT & Allergy
Colorado Springs, Colorado, 80923, United States
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University of Cincinnati
Cincinnati, Ohio, 45267, United States
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Other studies related to the condition(s) this trial covers.
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