Nasal ObstructionNCT05920330
Nasal Obstruction and Olfactory Losses
A study testing Nasal Plug in people with Nasal Obstruction, run by Ohio State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Nasal Obstruction
- What is being tested?
- Nasal Plug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Smell Loss complaints
- Nasal Obstruction
Who cannot join
- Congenital olfactory losses
- Nasal polyps, blocking the olfactory cleft
- Significant atrophy
- Cystic fibrosis
- Wegeners or any other connective tissue disorder
- Head trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000
Columbus, Ohio, 43212
Veronica Formanek, BS, 630-501-8168, Veronica.Formanek@osumc.edu
Beth Miles-Markley, MS, 614-366-9244, Beth.Miles-Markley@osumc.edu
About this study
Official title: Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
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.
Read the 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.
- Conditions
- Nasal Obstruction
- Being tested
- Nasal Plug
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal PlugOther
Also called Swimmer's nose clip
Please see the arm description for details.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | 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. Receives: Other: Nasal Plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.
Measured: 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
A visual analog scale of nasal obstruction (VAS), with ratings from 0 to 10 (0 = completely clear; 10 = completely obstructed).
Measured: 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)
A validated ENS-specific symptom questionnaire.
Measured: 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 (3)
Change in Sino-nasal Outcome Test (SNOT-22)
A validated questionnaire documenting general nasal sinus symptoms.
Measured: 1-baseline (done on the first day of testing)and 2- 8 weeks after surgery
Change in nasal resistance
Anterior rhinomanometry will be used to measure airflow and pressures during normal breathing.
Measured: 1-baseline (done on the first day of testing) and 2- 8 weeks after surgery
Change in rhinomanometry
The narrowest area of the nasal airway measured by an acoustic rhinometry.
Measured: 1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2023
- Study start25 Jan 2023
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal ObstructionStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients experiencing olfactory impairment and/or nasal obstruction, self-referred to participate in the research study.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Zhao, Ohio State University
- Investigators
- Kai Zhao, Ph.D, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05920330
- Sponsor's protocol ID
- 2015H0262
- Status last verified
- May 2026
- First submitted
- 22 May 2023
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 40128836
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
- ClinicalTrials.gov ID
- NCT05920330
- Acronym / sponsor ID
- 2015H0262
- Conditions
- Nasal Obstruction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients experiencing olfactory impairment and/or nasal obstruction, self-referred to participate in the research study.
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Other: Nasal PlugA 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Smell Loss complaints
- Nasal Obstruction
Key exclusion criteria (6 listed)
- Congenital olfactory losses
- Nasal polyps, blocking the olfactory cleft
- Significant atrophy
- Cystic fibrosis
- Wegeners or any other connective tissue disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal PlugAlso: Swimmer's nose clipPlease see the arm description for details. | Other | Single Arm |
Primary outcome
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.
A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.
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.
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)
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
- Derived from this study: PubMed 40128836Formanek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kai Zhao, Ph.D principal investigator
Associate Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal Plug in people with Nasal Obstruction, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Veronica Formanek, BS (630-501-8168, Veronica.Formanek@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05920330, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.