Nasal Obstruction and Olfactory Losses

Nasal Obstruction Clinical Trial

Official title:

Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920330
• Other study ID #: 2015H0262
• Status: Recruiting
• Phase: N/A
• Start date: January 25, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: June 2023
• Source: Ohio State University
• Contact: Veronica Formanek, BS
• Phone: 630-501-8168
• Email: Veronica.Formanek[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 330
• Est. completion date: December 31, 2028
• Est. primary completion date: July 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Nasal Obstruction

Intervention

Other:
• Nasal Plug
Please see the arm description for details.

Locations

Country	Name	City	State
United States	Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	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
Secondary	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
Secondary	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