Nasal Obstruction and Olfactory Losses

NCT ID: NCT05920330

Last Updated: 2025-03-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-25
• Study Completion Date: 2028-12-31

Brief 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.

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.

Conditions

Nasal Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Nasal Plug

Intervention Type: OTHER

Please see the arm description for details.

Interventions

Nasal Plug

Please see the arm description for details.

Intervention Type: OTHER

Other Intervention Names

Swimmer's nose clip

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Kai Zhao

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kai Zhao, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

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

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Veronica Formanek, BS

Role: CONTACT

Veronica.Formanek@osumc.edu

630-501-8168

Beth Miles-Markley, MS

Role: CONTACT

Beth.Miles-Markley@osumc.edu

614-366-9244

Facility Contacts

Veronica Formanek, BS

Role: primary

Veronica.Formanek@osumc.edu

630-501-8168

Beth Miles-Markley, MS

Role: backup

Beth.Miles-Markley@osumc.edu

614-366-9244

References

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.

Reference Type: DERIVED

PMID: 40128836 (View on PubMed)

Other Identifiers

2015H0262

Identifier Type: -

Identifier Source: org_study_id