NCT05920330

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
330

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Jan 2023Dec 2028

Study Start

First participant enrolled

January 25, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 22, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2023

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

4.5 years

First QC Date

May 22, 2023

Last Update Submit

March 18, 2025

Conditions

Nasal Obstruction

Outcome Measures

Primary Outcomes (3)

  • Change in Nasal Obstruction Symptom Evaluation (NOSE) questionnaire

    A clinically validated 5 item questionnaire to document general nasal obstruction. symptoms severity.

    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).

    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.

    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)

    1-baseline (done on the first day of testing)and 2- 8 weeks after surgery

  • Change in nasal resistance

    1-baseline (done on the first day of testing) and 2- 8 weeks after surgery

  • Change in rhinomanometry

    1-Baseline (done on the first day of testing) and 2- 8 weeks post-surgery

Study Arms (1)

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.

Other: Nasal Plug

Interventions

Nasal PlugOTHER

Please see the arm description for details.

Also known as: Swimmer's nose clip
Single Arm

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Smell Loss complaints
  • Nasal Obstruction

You may not qualify if:

  • Congenital olfactory losses
  • Nasal polyps, blocking the olfactory cleft
  • Significant atrophy
  • Cystic fibrosis
  • Wegeners or any other connective tissue disorder
  • Head trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Columbus, Ohio, 43212, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 40128836DERIVED

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Kai Zhao, Ph.D

    Associate Professor

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Veronica Formanek, BS

CONTACT

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

Beth Miles-Markley, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Patients experiencing olfactory impairment and/or nasal obstruction, self-referred to participate in the research study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 22, 2023

First Posted

June 27, 2023

Study Start

January 25, 2023

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)