Recruiting

Observational Study

Sponsor:

Ohio State University

Code:

NCT05920330

Conditions

Nasal Obstruction

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Nasal Plug

Study Details

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.

Conditions

Nasal Obstruction

Study ID

NCT05920330

Start date

Jan 25, 2023

Status verified date

May, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

330 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

other: Single Arm

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.

Interventions

Nasal Plug

Please see the arm description for details.

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. ]
  • 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. ]
  • 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. ]

Central Contacts and Locations

Central contacts

Veronica Formanek, BS

630-501-8168Veronica.Formanek@osumc.edu

Beth Miles-Markley, MS

614-366-9244Beth.Miles-Markley@osumc.edu

Locations

Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Veronica Formanek, BS

630-501-8168Veronica.Formanek@osumc.edu

Beth Miles-Markley, MS

614-366-9244Beth.Miles-Markley@osumc.edu

Principal Investigator:

Kai Zhao, Ph.D

More Information

Sponsor

Ohio State University

Last update posted

May 26, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-05-26.