Nasal Obstruction and Olfactory Losses
Primary Purpose
Nasal Obstruction
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal Plug
Sponsored by
About this trial
This is an interventional supportive care trial for Nasal Obstruction
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
Sites / Locations
- Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000Recruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
A device-nasal plug will be self-inserted into the nose with a diagonal channel embedded to redirect nasal airflow patterns to different nasal regions. A nose clip will be used to pinch the nose externally, similar to what synchronized swimmers use.
Outcomes
Primary Outcome Measures
Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.
Change in Visual Analog Scale (VAS) of nasal obstruction
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)
A validated ENS-specific symptom questionnaire.
Secondary Outcome Measures
Change in Sino-nasal Outcome Test (SNOT-22)
A validated questionnaire documenting general nasal sinus symptoms.
Change in nasal resistance
Anterior rhinomanometry will be used to measure airflow and pressures during normal breathing.
Change in rhinomanometry
The narrowest area of the nasal airway measured by an acoustic rhinometry.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05920330
Brief Title
Nasal Obstruction and Olfactory Losses
Official Title
Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 25, 2023 (Actual)
Primary Completion Date
July 31, 2027 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasal Obstruction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Patients experiencing olfactory impairment and/or nasal obstruction, self-referred to participate in the research study.
Masking
None (Open Label)
Allocation
N/A
Enrollment
330 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
A device-nasal plug will be self-inserted into the nose with a diagonal channel embedded to redirect nasal airflow patterns to different nasal regions. A nose clip will be used to pinch the nose externally, similar to what synchronized swimmers use.
Intervention Type
Other
Intervention Name(s)
Nasal Plug
Other Intervention Name(s)
Swimmer's nose clip
Intervention Description
Please see the arm description for details.
Primary Outcome Measure Information:
Title
Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
Description
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.
Title
Change in Visual Analog Scale (VAS) of nasal obstruction
Description
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.
Title
Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q)
Description
A validated ENS-specific symptom 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.
Secondary Outcome Measure Information:
Title
Change in Sino-nasal Outcome Test (SNOT-22)
Description
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
Title
Change in nasal resistance
Description
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 after surgery
Title
Change in rhinomanometry
Description
The narrowest area of the nasal airway measured by an acoustic rhinometry.
Time Frame
1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronica Formanek, BS
Phone
630-501-8168
Email
Veronica.Formanek@osumc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Beth Miles-Markley, MS
Phone
614-366-9244
Email
Beth.Miles-Markley@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kai Zhao, Ph.D
Organizational Affiliation
Associate Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Veronica Formanek, BS
Phone
630-501-8168
Email
Veronica.Formanek@osumc.edu
First Name & Middle Initial & Last Name & Degree
Beth Miles-Markley, MS
Phone
614-366-9244
Email
Beth.Miles-Markley@osumc.edu
First Name & Middle Initial & Last Name & Degree
Kai Zhao, Ph.D
12. IPD Sharing Statement
Plan to Share IPD
No
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Nasal Obstruction and Olfactory Losses
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