Nasal Obstruction and Olfactory Losses

Last updated: March 18, 2025
Sponsor: Ohio State University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Acute Rhinitis

Nasal Obstruction

Treatment

Nasal Plug

Clinical Study ID

NCT05920330
2015H0262
  • Ages 18-70
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

About 13% of US adults, some 30 million people, suffer from nasal sinus disease. Although nasal obstruction and smell loss are two of the major symptoms of the disease that are crucial to disease management, currently there is a lack of clinical tools to effectively evaluate the mechanisms contributing to these symptoms. The proposed study aims to develop novel clinical tools to better evaluate and relieve patients' nasal obstructive symptoms and to enable patients and clinicians to make more informed, personalized decisions regarding treatment strategy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Smell Loss complaints

  2. Nasal Obstruction

Exclusion

Exclusion Criteria:

  1. Congenital olfactory losses

  2. Nasal polyps, blocking the olfactory cleft

  3. Significant atrophy

  4. Cystic fibrosis

  5. Wegeners or any other connective tissue disorder

  6. Head trauma

Study Design

Total Participants: 330
Treatment Group(s): 1
Primary Treatment: Nasal Plug
Phase:
Study Start date:
January 25, 2023
Estimated Completion Date:
December 31, 2028

Study Description

Nasal sinus disease is one of the most common medical conditions in the US, affecting an estimated 13% of adults, or some 30 million people, and responsible for $5.8 billion in health care expenditures annually (National Health Interview Survey 2009, CDC). Nasal obstruction and smell loss are two of the major symptoms of the disease; however, the field currently lacks a clear, objective understanding of the mechanisms causing these symptoms, which thwarts effective treatment. For example, patients' complaints of nasal obstruction correlate poorly or inconsistently with objective measurements of actual physical obstruction. Without validated clinical tools, the current treatment of these symptoms relies primarily on the patient's subjective feedback and the doctor's personal training and experience, which can lead to inconsistent and unsatisfactory outcomes.

Through a series of preliminary studies, the investigators demonstrated that the symptom of nasal obstruction may be caused not by obstruction per se but by poor sensing of airflow during breathing or sensing may be worsened by impaired trigeminal function. However, which trigeminal sensory regions and what nasal airflow anomalies are most critical in disrupting the sensing of airflow are still unknown. In Aim 2, the investigators will investigate the efficacy of a novel patent-pending "nasal aid" to improve patients' symptoms by modulating nasal airflow and trigeminal sensory feedback and to improve future treatment outcomes based on what the investigators have learned and will continue to learn about the airflow trigeminal perception mechanisms.

The outcomes from this research may potentially validate several novel clinical tools to better identify factors that most affect patients' obstructive symptoms and to relieve symptoms by modulating nasal airflow patterns. The ultimate goal is to assist patients and clinicians in planning effective, well-informed, personalized treatment strategies, potentially saving millions of healthcare dollars annually while improving patient satisfaction.

Connect with a study center

  • Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000

    Columbus, Ohio 43212
    United States

    Active - Recruiting

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