Ignite Creation Date:
2024-05-06 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05920330
Status:
RECRUITING
Last Update Posted:
2023-06-29
First Post:
2023-05-22
Brief Title:
Nasal Obstruction and Olfactory Losses
Sponsor:
Ohio State University
Organization:
Ohio State University
Study Overview
Official Title:
Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 58 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 patients subjective feedback and the doctors 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None