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Nasal Obstruction and Olfactory Losses

Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05920330
Enrollment
330
Registered
2023-06-27
Start date
2023-01-25
Completion date
2028-12-31
Last updated
2026-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Obstruction

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.

Interventions

OTHERNasal Plug

Please see the arm description for details.

Sponsors

Ohio State University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Patients experiencing olfactory impairment and/or nasal obstruction, self-referred to participate in the research study.

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire3 time points: 1-baseline, 2-after the applications of nasal aid (done on the first day of testing), and 3- 8 weeks after surgery.A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.
Change in Visual Analog Scale (VAS) of nasal obstruction3 time points:1-baseline, 2-after the applications of nasal aid (done on the first day of testing) and 3-8 weeks after surgery.A visual analog scale of nasal obstruction (VAS), with ratings from 0 to 10 (0 = completely clear; 10 = completely obstructed).
Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q)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.A validated ENS-specific symptom questionnaire.

Secondary

MeasureTime frameDescription
Change in Sino-nasal Outcome Test (SNOT-22)1-baseline (done on the first day of testing)and 2- 8 weeks after surgeryA validated questionnaire documenting general nasal sinus symptoms.
Change in nasal resistance1-baseline (done on the first day of testing) and 2- 8 weeks after surgeryAnterior rhinomanometry will be used to measure airflow and pressures during normal breathing.
Change in rhinomanometry1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgeryThe narrowest area of the nasal airway measured by an acoustic rhinometry.

Countries

United States

Contacts

CONTACTVeronica Formanek, BS
Veronica.Formanek@osumc.edu630-501-8168
CONTACTBeth Miles-Markley, MS
Beth.Miles-Markley@osumc.edu614-366-9244
PRINCIPAL_INVESTIGATORKai Zhao, Ph.D

Associate Professor

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 27, 2026