Nasal Obstruction and Olfactory Losses

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses

Conditions
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Nasal Obstruction

Intervention / Treatment
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* Other: Nasal Plug


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: Patients experiencing olfactory impairment and/or nasal obstruction, self-referred to participate in the research study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>A device-nasal plug will be self-inserted into the nose with a diagonal channel embedded to redirect nasal airflow patterns to different nasal regions. A nose clip will be used to pinch the nose externally, similar to what synchronized swimmers use. | Other: Nasal Plug<br>* Please see the arm description for details.<br>* Other names: Swimmer's nose clip;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire | A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity. | 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. | 
| Change in Visual Analog Scale (VAS) of nasal obstruction | A visual analog scale of nasal obstruction (VAS), with ratings from 0 to 10 (0 = completely clear; 10 = completely obstructed). | 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. | 
| Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q) | A validated ENS-specific symptom questionnaire. | 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. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sino-nasal Outcome Test (SNOT-22) | A validated questionnaire documenting general nasal sinus symptoms. | 1-baseline (done on the first day of testing)and 2- 8 weeks after surgery | 
| Change in nasal resistance | Anterior rhinomanometry will be used to measure airflow and pressures during normal breathing. | 1-baseline (done on the first day of testing) and 2- 8 weeks after surgery | 
| Change in rhinomanometry | The narrowest area of the nasal airway measured by an acoustic rhinometry. | 1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery |