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 range

18 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Nasal Obstruction trials