Nasal Obstruction and Olfactory Losses

Novel Mechanisms and Therapeutic Approaches for 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.

Study Overview

• Status: Recruiting
• Conditions: Nasal Obstruction
• Intervention / Treatment: Other: Nasal Plug

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 330
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronica Formanek, BS; Phone Number: 630-501-8168; Email: Veronica.Formanek@osumc.edu
• Study Contact Backup: Name: Beth Miles-Markley, MS; Phone Number: 614-366-9244; Email: Beth.Miles-Markley@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43212
      • Recruiting
      • Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000
      • Contact: Veronica Formanek, BS; Phone Number: 630-501-8168; Email: Veronica.Formanek@osumc.edu
      • Contact: Beth Miles-Markley, MS; Phone Number: 614-366-9244; Email: Beth.Miles-Markley@osumc.edu
      • Principal Investigator: Kai Zhao, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Study Population

Adult participants are able to read and provide consent.

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single Arm; 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; Please see the arm description for details.; Other Names: Swimmer's nose clip

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Kai Zhao, Ph.D, Associate professor

Publications and helpful links

General Publications

• Formanek VL, Spector BM, Zappitelli G, Wu Z, Zhao K. Designing novel "Smell-Aids" to improve olfactory function in post COVID-19 era. BMC Med. 2025 Mar 24;23(1):169. doi: 10.1186/s12916-025-03999-y.

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: 2015H0262

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No