Designing novel "Smell-Aids" to improve olfactory function in post COVID-19 era.
Veronica L Formanek, Barak M Spector, Gabriela Zappitelli...
https://pubmed.ncbi.nlm.nih.gov/40128836Actively Recruiting
Phase Not Applicable
Age: 18Years - 70Years
All Genders
Healthy Volunteers
ID05920330
Novel Mechanisms and Therapeutic Approaches for Nasal Obstruction and Olfactory Losses
Led by Ohio State University · Updated on 2026-05-26
330
Participants Needed
1
Research Sites
74 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Nasal sinus disease affects about 13% of adults in the US, causing symptoms like nasal obstruction and loss of smell that are important to manage but not well understood. This trial aims to develop new clinical tools to better assess and relieve these nasal obstructive symptoms, helping patients and doctors make more personalized treatment decisions. The study focuses on understanding airflow perception and trigeminal nerve function related to nasal obstruction. Participants will use a novel nasal device that includes a nasal plug with a diagonal channel to redirect airflow and a nose clip to pinch the nose externally. This device is designed to alter nasal airflow patterns and trigeminal sensory feedback, potentially improving symptoms. The study includes baseline assessments, application of the nasal aid on the first testing day, and follow-up at 8 weeks after surgery to evaluate changes. During the study, participants will complete questionnaires on nasal obstruction symptoms and undergo measurements of nasal resistance and airflow. These assessments occur at baseline, immediately after using the nasal aid, and 8 weeks post-surgery. Researchers will monitor symptom changes and airflow to better understand nasal airflow mechanisms and improve personalized treatment strategies. The total participation period includes initial testing and an 8-week follow-up.
CONDITIONS
Brief Title
Nasal Obstruction and Olfactory Losses
Who Can Participate
Age: 18Years - 70Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Smell loss complaints
- Nasal obstruction
- Adults aged 18 to 70 years
You will not qualify if you...
- Congenital olfactory losses
- Nasal polyps blocking the olfactory cleft
- Significant atrophy
- Cystic fibrosis
- Wegener's or other connective tissue disorders
- Head trauma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Single day for nasal aid application with follow-up until 8 weeks post-application
Participants self-insert a nasal plug device designed to redirect nasal airflow patterns and use a nose clip to modulate nasal airflow and sensory feedback.
1 baseline visit and 1 immediate post-application visit
Follow-up
Duration - 8 weeks after treatment
Participants are assessed up to 8 weeks after the nasal aid application to evaluate changes in nasal obstruction symptoms and nasal function.
1 follow-up visit approximately 8 weeks after the nasal aid application
Trial Site Locations
Total: 1 location
1
Eye and Ear Institute, 915 Olentangy River Road, ENT, Suite 4000
Columbus, Ohio, United States, 43212
Actively Recruiting
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Research Team
V
Veronica Formanek, BS
B
Beth Miles-Markley, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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