CompletedNot Applicable

A New Treatment for Mechanical Nasal Obstruction

United States36 participantsStarted 2018-10-01

Plain-language 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?

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Peak Nasal Inspiratory Flow (PNIF)

Timeframe: Prior to device and after fitting each device (Up to 5 minutes)

Trial details

NCT IDNCT03456115

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-05-12

Results submitted2023-05-10