Nasal Obstruction and Olfactory Losses

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT05920330
Status
Recruiting

Conditions

  • Nasal Obstruction

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Nasal Plug — OTHER
    Please see the arm description for details.

Study Details

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.

Key Dates

Start date
Jan 25, 2023
Status verified
May 2026
Primary completion
Jul 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
330 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000ColumbusOhio43212
Veronica Formanek, BS
630-501-8168
Beth Miles-Markley, MS
614-366-9244
Kai Zhao, Ph.D (PRINCIPAL_INVESTIGATOR)

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