Laser Posterior Nasal Nerve Neurolysis

NCT07050992 | Active Not Recruiting DMC

• 1 other identifier: IRB2024071
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to learn if laser posterior nasal nerve neurolysis can treat chronic rhinitis in adults. It will also learn about the safety of laser posterior nasal nerve neurolysis. The main questions it aims to answer are:

1. 1.Does laser posterior nasal nerve neurolysis improve chronic rhinitis symptoms?
2. 2.What side-effects or complications do participants have after laser posterior nasal nerve neurolysis?
3. 3.Receive laser posterior nasal nerve neurolysis in the office as local anesthesia surgery.
4. 4.Visit the clinic in the first week, first month, and 3rd months after the surgery.
5. 5.Record their symptom scores before the surgery and during each follow-up visit.

Conditions

Allergic Rhinitis; Chronic Rhinitis; Rhinorrhea; Sneezing; Nasal Obstruction; Nasal Congestion; Nasal Allergies; Nasal Stuffiness

Keywords

laser; posterior nasal nerve; rhinitis; allergy

Outcome Measures

Primary Outcomes (1)

• Change in chronic rhinitis score

  The investigators will use reflective total nasal symptom score, (rTNSS, 0-12, the higher the worse) and Nasal Obstruction Symptom Evaluation(NOSE, 0-20, the higher the worse) to compare the chronic rhinitis symptoms before and after the intervention.

  From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.

Secondary Outcomes (1)

• Complications of the intervention

  From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.

Other Outcomes (1)

• Change in sleep quality and day time sleepiness scale

  From the date of randomization and every three months after intervention is performed on 3, 6, 9, and 12 months post intervention.

Study Arms (2)

Laser surgery

ACTIVE COMPARATOR

Posterior nasal nerve ablation using laser to deliver laser energy to the posterior nasal nerve area.

Procedure: Laser posterior nasal nerve neurolysis

Sham surgery

SHAM COMPARATOR

Sham surgery is performed with the same laser surgical instrument used to enter the nasal cavity for a sham procedure with minimal dosage.

Procedure: Sham surgery

Interventions

Laser posterior nasal nerve neurolysis PROCEDURE

Posterior nasal nerve ablation using laser is performed through an angled nasal probe at 20 degrees and a 90-degree endoscope to deliver laser energy to the posterior nasal nerve area. The thermal energy is conducted to the middle meatus and the posterior superior part of the inferior turbinate, targeting the area supplied by the posterior nasal nerve. The ablation continues until there is widespread mucosal blanching and the formation of at least one continuous brown eschar

Laser surgery

Sham surgery PROCEDURE

The same laser surgical instrument is used to enter the nasal cavity for a sham procedure with minimal dosage. The energy setting uses the lowest limit of 0.5W with intermittent emission (0.01 second emission with 1 second rest), and the emission mode is Super Pulse to reduce heat dispersion. It is applied to the mucosal surface without blood supply at the lower edge of the middle turbinate for 2 minutes on each side, totaling only 1.2 seconds of cumulative laser emission. Compared to the experimental group using 2W energy with continuous irradiation for 2 minutes, the total energy release difference in the sham surgery group is only 1/400 of the experimental group (2W120sec/0.5W1.2sec). This is to produce the sound, light, and tactile effects of the laser, but without sufficient energy transfer to cause high-temperature mucosal changes and tissue alterations, serving as a high-quality sham surgery control group.

Sham surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years old
• Chronic rhinitis symptoms for at least 6 months that have not responded effectively to medication (should include at least Intranasal corticosteroid (ICS) combined with intermittent use of oral antihistamine and, as needed, combination nasal spray) or where medication has not provided sustained improvement
• Total rTNSS ≥ 5 with Moderate to severe rhinorrhea symptoms (24-hour reflective Total Nasal Symptom Score \[rTNSS\] rhinorrhea score of 2-3) and mild to severe nasal congestion symptoms (rTNSS nasal congestion score of 1-3)
• All enrolled patients routinely undergo endonasal endoscopic examination, or have had a sinus CT within the past month confirming no significant rhinosinusitis."

You may not qualify if:

• Obstructive anatomical abnormalities limiting access to posterior nasal passages
• Nasal anatomical changes due to previous sinus or nasal surgery or injury
• Ongoing nasal or sinus infection
• History of severe dry eye, chronic epistaxis, rhinitis medicamentosa, or head and neck radiotherapy
• Self-reported history of bleeding tendency
• Current use of anticoagulants with inability to discontinue
• Previous chronic rhinitis surgery
• History of poor wound healing after head, neck, or throat surgery

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Study Sites (1)

Ditmanson Medical Foundation Chia-Yi Christian Hospital

Chiayi City, Taiwan, 600, Taiwan

Location

Related Publications (2)

• Lee JT, Abbas GM, Charous DD, Cuevas PDMM, Goktas PDMO, Loftus PA, Nachlas NE, Toskala EM, Watkins JP, Brehmer PDMD. Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis. Am J Rhinol Allergy. 2022 Nov;36(6):747-754. doi: 10.1177/19458924221109987. Epub 2022 Jul 11.

  PMID: 35818709 BACKGROUND

• Takashima M, Stolovitzky JP, Ow RA, Silvers SL, Bikhazi NB, Johnson CD. Temperature-controlled radiofrequency neurolysis for treatment of chronic rhinitis: 12-month outcomes after treatment in a randomized controlled trial. Int Forum Allergy Rhinol. 2023 Feb;13(2):107-115. doi: 10.1002/alr.23047. Epub 2022 Jul 5.

  PMID: 35714267 BACKGROUND

Related Links

• Position Statement: PNN Ablation for the Treatment of Chronic Rhinitis

MeSH Terms

Conditions

Rhinitis, Allergic; Rhinorrhea; Sneezing; Nasal Obstruction; Rhinitis; Hypersensitivity

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Immune System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Infections; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2024
• First Posted: July 3, 2025
• Study Start: November 1, 2024
• Primary Completion: December 6, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)