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Nasal Plug for Nasal Congestion

N/A
Recruiting
Led By Kai Zhao, Ph.D
Research Sponsored by Ohio State University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Smell Loss complaints
Nasal Obstruction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1-baseline (done on the first day of testing) and 2- 8 weeks post-surgery
Awards & highlights

Study Summary

This trial aims to develop tools that help diagnose and treat nasal sinus disease, which affects 30 million Americans and can cause nose blockage and smell loss.

Who is the study for?
This trial is for adults who are experiencing smell loss and nasal obstruction, but not due to head trauma, congenital issues, significant atrophy, connective tissue disorders like Wegeners, nasal polyps blocking the olfactory cleft or cystic fibrosis.Check my eligibility
What is being tested?
The study is developing new clinical tools to assess and manage symptoms of nasal sinus disease. It focuses on relieving nasal blockage and smell loss so patients can choose better treatment options.See study design
What are the potential side effects?
Since this trial involves testing diagnostic tools rather than medications or invasive procedures, side effects may be minimal but could include discomfort from using the nasal plug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have experienced a loss of smell.
Select...
I have difficulty breathing through my nose.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1-baseline (done on the first day of testing) and 2- 8 weeks post-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1-baseline (done on the first day of testing) and 2- 8 weeks post-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Empty Nose Syndrome 6-Item Questionnaire (ENS 6 Q)
Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire
Change in Visual Analog Scale (VAS) of nasal obstruction
Secondary outcome measures
Change in Sino-nasal Outcome Test (SNOT-22)
Change in nasal resistance
Change in rhinomanometry

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
830 Previous Clinical Trials
505,290 Total Patients Enrolled
Kai Zhao, Ph.DPrincipal InvestigatorAssociate Professor

Media Library

Single Arm Clinical Trial Eligibility Overview. Trial Name: NCT05920330 — N/A
Nasal Congestion Research Study Groups: Single Arm
Nasal Congestion Clinical Trial 2023: Single Arm Highlights & Side Effects. Trial Name: NCT05920330 — N/A
Single Arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT05920330 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the qualifications necessary for participating in this clinical investigation?

"To participate in the clinical trial, applicants must suffer from nasal blockage and be between 18 to 70 years of age. In total, 330 patients will have access to this medication."

Answered by AI

Are further volunteers being accepted for the experiment?

"Per clinicaltrials.gov, this research is currently open for enrolment. It was initially published on January 25th 2023 and the details were last adjusted on June 27th 2023."

Answered by AI

How many participants will this clinical trial accommodate?

"Correct. Clinicaltrials.gov affirms that this clinical trial was established on January 25th, 2023 and is currently enlisting participants; 330 individuals are needed at a solitary site to complete the study."

Answered by AI

Are people aged 55 and above accepted into this research study?

"The upper age limit for this trial is 70 years old, and applicants must be at least 18."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Nasal Obstruction and Olfactory Losses
Kai Zhao 2023. "Nasal Obstruction and Olfactory Losses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05920330.
~220 spots leftby Jul 2027
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