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NCT Number: NCT05920330

Nasal Obstruction and Olfactory Losses

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Columbus, Ohio, 43212, United States

Location status: Recruiting

Location contact

Beth Miles-Markley, MS

CONTACT

[email protected]

614-366-9244

Kai Zhao, Ph.D

PRINCIPAL_INVESTIGATOR

Veronica Formanek, BS

CONTACT

[email protected]

630-501-8168

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Smell Loss complaints
  • Nasal Obstruction

Exclusion criteria

  • Congenital olfactory losses
  • Nasal polyps, blocking the olfactory cleft
  • Significant atrophy
  • Cystic fibrosis
  • Wegeners or any other connective tissue disorder
  • Head trauma

Treatment and study plan

Nasal Plug

Other

Please see the arm description for details.

Other names: Swimmer's nose clip

Primary outcomes

  1. Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire

    Time frame: 3 time points: 1-baseline, 2-after the applications of nasal aid (done on the first day of testing), and 3- 8 weeks after surgery.

    A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.

  2. Change in Visual Analog Scale (VAS) of nasal obstruction

    Time frame: 3 time points:1-baseline, 2-after the applications of nasal aid (done on the first day of testing) and 3-8 weeks after surgery.

    A visual analog scale of nasal obstruction (VAS), with ratings from 0 to 10 (0 = completely clear; 10 = completely obstructed).

  3. Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q)

    Time frame: 3 time points:1-baseline, 2-after the applications of nasal aid (done on the first day of testing) and 3-8 weeks after surgery.

    A validated ENS-specific symptom questionnaire.

Secondary outcomes

  1. Change in Sino-nasal Outcome Test (SNOT-22)

    Time frame: 1-baseline (done on the first day of testing)and 2- 8 weeks after surgery

    A validated questionnaire documenting general nasal sinus symptoms.

  2. Change in nasal resistance

    Time frame: 1-baseline (done on the first day of testing) and 2- 8 weeks after surgery

    Anterior rhinomanometry will be used to measure airflow and pressures during normal breathing.

  3. Change in rhinomanometry

    Time frame: 1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery

    The narrowest area of the nasal airway measured by an acoustic rhinometry.

Study contacts

Contact information is provided by the study sponsor or research team.

Beth Miles-Markley, MS

CONTACT

[email protected]

614-366-9244

Veronica Formanek, BS

CONTACT

[email protected]

630-501-8168

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Registry information

Official study title

Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jun 27, 2023
Registry last updated
May 26, 2026

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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