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Completed

NCT Number: NCT05648565

Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis

The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.

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Key information

Conditions

Chronic Rhinitis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • chronic rhinitis symptoms for at least 6 months (rhinorrhea, congestion, post-nasal drip)
  • poor response to medical management that was attempted for at least 4 weeks
  • a rTNSS score ≥6, as well as ≥2 for rhinorrhea, and ≥1 for congestion.

Exclusion criteria

  • active sinusitis
  • rhinitis medicamentosa
  • recurrent and ongoing epistaxis
  • immunodeficiency as defined by an illness or a history of sinus surgery.

Treatment and study plan

Radiofrequency ablation (RFA)

Device

The NEUROMARK device is an in-office, disposable bipolar RFA device with a treatment tip consisting of micro electrodes which delivers RF energy while monitoring appropriate tissue contact to maximize delivery to posterior nasal nerve and its variable branching. After topical anesthesia consisting of oxymetazoline and 1% lido followed by 4% lidocaine, the device will be placed in the posterior inferior turbinate under endoscopic visualization. The device will be activated per manufacturer's instructions

Primary outcomes

  1. Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)

    Time frame: Baseline

    PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute.

  2. Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)

    Time frame: 4 weeks post intervention

    PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute

  3. Nasal Congestion as Assessed by the Peak Nasal Inspiratory Flow (PNIF)

    Time frame: 12 weeks post intervention

    PNIF is used to assess nasal air flow during maximal inspiration, and is reported in liters per minute

  4. Interleukin-10 (IL-10)

    Time frame: Baseline

    cytokine

  5. Interleukin-22 (IL-22)

    Time frame: Baseline

    cytokine

  6. Interleukin-10 (IL-10)

    Time frame: 12 weeks post intervention

    cytokine

  7. Interleukin-22 (IL-22)

    Time frame: 12 weeks post intervention

    cytokine

Secondary outcomes

  1. Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)

    Time frame: Baseline

    This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion

  2. Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 4 weeks post intervention

    This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion

  3. Nasal Congestion as Assessed by the Reflective Total Nasal Symptom Score (rTNSS)

    Time frame: 12 weeks post intervention

    This is a 4 item questionnaire and each is scored from 0(none) to 3(severe). The sum of the 4 times were added to generate a scale from 0 to 12, a higher number indicating more congestion

  4. Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)

    Time frame: Baseline

    This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.

  5. Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)

    Time frame: 4 weeks post intervention

    This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.

  6. Nasal Obstruction as Assessed by the Nasal Obstruction Symptom Evaluation Survey (NOSE)

    Time frame: 12 weeks post intervention

    This is a 5 item self reported questionnaire and each is scored from 0(not a problem) - 4(severe problem). The sum of the 5 items were multiplied by 5, to generate a scale from 0 to 100, a higher score indicated more obstruction.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • American Academy of Otolaryngic Allergy

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 13, 2022
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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