N/A
N=36
A New Treatment for Mechanical Nasal Obstruction
Nasal Obstruction
Bottom Line
View on ClinicalTrials.gov: NCT03456115 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Change in Peak Nasal Inspiratory Flow (PNIF) — 28; 24; 13; 27 liters per minute
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mechanical nasal dilator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Peak Nasal Inspiratory Flow (PNIF) |
28; 24; 13; 27; 25; 29 | — |
| SECONDARY Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) |
— | — |
| SECONDARY Change in Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) |
— | — |
| SECONDARY Device Preference |
2.9; 5; 3.8; 2.7; 2.8; 3.8 | — |
Summary
The research team has developed a prototype for an investigational mechanical nasal dilator and the investigators aim to evaluate its efficacy.
Specifically, the investigators wish to address the following research questions: 1) How does mechanical nasal obstruction affect patients' lives? The investigators aim to answer this question with use of validated questionnaires. 2) How do currently available mechanical nasal dilators affect objective and subjective findings related to nasal obstruction? This will be evaluated with objective nasal airflow testing and with modifications to validated questionnaires 3) How does the investigational team's novel device affect these same outcome measures? 4) Do patients find the investigational device subjectively comfortable and efficient?
Eligibility Criteria
Inclusion Criteria
- Patients who have presented to Otolaryngology clinics with complaints of nasal obstruction.
- Patients who have been found to have nasal valve collapse by an Otolaryngologist based on performance of the Cottle maneuver will be invited to participate in the study.
- Patients without evidence of nasal valve collapse, but are willing to participate in the study.
Exclusion Criteria
- History of granulomatosis with polyangiitis, extensive prior sinus or turbinate surgery altering nasal cavity anatomy, pre-existing nasal mucosal injuries or abnormalities
Data sourced from ClinicalTrials.gov (NCT03456115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.