Nasal Obstruction and Olfactory Losses
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Nasal Plug.
- Who it may be relevant to
- Registry conditions: Nasal Obstruction. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
Overview
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
- Other Nasal Plug
Please see the arm description for details.
Primary outcome measures
- Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire [Time frame: 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 [Time frame: 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) [Time frame: 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 (3)
- Change in Sino-nasal Outcome Test (SNOT-22) [Time frame: 1-baseline (done on the first day of testing)and 2- 8 weeks after surgery]
- Change in nasal resistance [Time frame: 1-baseline (done on the first day of testing) and 2- 8 weeks after surgery]
- Change in rhinomanometry [Time frame: 1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery]
Eligibility criteria
Inclusion criteria
- Smell Loss complaints
- Nasal Obstruction
Exclusion criteria
- Congenital olfactory losses
- Nasal polyps, blocking the olfactory cleft
- Significant atrophy
- Cystic fibrosis
- Wegeners or any other connective tissue disorder
- Head trauma
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000 — Columbus
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. PMID 40128836
Identifiers
NCT: NCT05920330 · 2015H0262