Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000
Columbus, Ohio, 43212, United States
Location status: Recruiting
Location contact
Beth Miles-Markley, MS
CONTACT
Kai Zhao, Ph.D
PRINCIPAL_INVESTIGATOR
Veronica Formanek, BS
CONTACT
NCT Number: NCT05920330
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Columbus, Ohio, 43212, United States
Location status: Recruiting
Beth Miles-Markley, MS
CONTACT
Kai Zhao, Ph.D
PRINCIPAL_INVESTIGATOR
Veronica Formanek, BS
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Please see the arm description for details.
Other names: Swimmer's nose clip
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.
A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.
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.
A visual analog scale of nasal obstruction (VAS), with ratings from 0 to 10 (0 = completely clear; 10 = completely obstructed).
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.
A validated ENS-specific symptom questionnaire.
Time frame: 1-baseline (done on the first day of testing)and 2- 8 weeks after surgery
A validated questionnaire documenting general nasal sinus symptoms.
Time frame: 1-baseline (done on the first day of testing) and 2- 8 weeks after surgery
Anterior rhinomanometry will be used to measure airflow and pressures during normal breathing.
Time frame: 1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery
The narrowest area of the nasal airway measured by an acoustic rhinometry.
Contact information is provided by the study sponsor or research team.
Beth Miles-Markley, MS
CONTACT
Veronica Formanek, BS
CONTACT
Ohio State University
Other
Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07379775
Airway Obstruction, Nasal Obstruction
Draguignan, Var, France
View Trial DetailsNCT07531810
Airway Obstruction, Nasal Deformity
Sivas, Turkey (Türkiye)
View Trial DetailsNCT07626437
Airway Obstruction, Common Cold
Belo Horizonte, Minas Gerais, Brazil
View Trial DetailsNCT06580210
Acute Rhinitis, Airway Obstruction
Bayeux, France
View Trial Details