Clinical trial NCT05920330: Nasal Obstruction and Olfactory Losses
Official title: Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Nasal Obstruction
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patients experiencing olfactory impairment and/or nasal obstruction, self-referred to participate in the research study.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
timeFrame: 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.
measure: Change in Visual Analog Scale (VAS) of nasal obstruction
timeFrame: 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.
measure: Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q)
timeFrame: 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 outcomes:
measure: Change in Sino-nasal Outcome Test (SNOT-22)
timeFrame: 1-baseline (done on the first day of testing)and 2- 8 weeks after surgery
measure: Change in nasal resistance
timeFrame: 1-baseline (done on the first day of testing) and 2- 8 weeks after surgery
measure: Change in rhinomanometry
timeFrame: 1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000
state: Ohio
Study officials:
affiliation: Associate Professor
name: Kai Zhao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: