MedTrace Logo

A New Treatment for Mechanical Nasal Obstruction

NCT03456115 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-07-18

Study results available
· View outcomes & findings →

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?

Conditions

  • Nasal Obstruction

Interventions

DEVICE

Mechanical nasal dilator

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.

Sponsors & Collaborators

Principal Investigators

  • Nicholas Rowan · Johns Hopkins University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2022-05-12
Completion
2022-05-12
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03456115 on ClinicalTrials.gov