CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Mechanical nasal dilatordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03456115
NCT03456115N/ACompleted

Assessing Mechanical Nasal Obstruction, a Potential New Treatment Option.

Johns Hopkins University·interventional·Posted Mar 7, 2018·Updated Jul 18, 2023

In Brief

A clinical study evaluating Mechanical nasal dilator for Nasal Obstruction. Completed, enrolled 36 participants across 1 site.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedMar 7, 2018
Enrollment StartOct 1, 2018
Primary CompletionMay 12, 2022
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 8.3 years ago

Interventions

Mechanical nasal dilatordevice

Participants will be asked to trial 5 different mechanical nasal dilators. 4 of which are commercially available and one of which is the investigational device being studied for feasibility. The 4 commercially available nasal dilators include Breathe Right, Max Air, Sleep Right, Nozovent. The fifth device is the study team's investigational device dubbed the Schnozzle.