Nasal Obstruction and Olfactory Losses

The Ohio State University

Status: Enrolling

Conditions: Nasal Obstruction

Treatments: Other: Nasal Plug

Study type: Interventional

Funder types: Other

Identifiers

NCT05920330

2015H0262

Details and patient eligibility

About

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.

Full 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.

Enrollment: 330 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Smell Loss complaints
2. Nasal Obstruction

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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330 participants in 1 patient group

Single Arm

Other group

Description:

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.

Treatment:

Other: Nasal Plug