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COMPLETED

Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing

NCT03850197 · View on ClinicalTrials.gov ↗

Study Summary

The Eustachian tube (ET) is a biological tube that links the middle ear to the back of the nose and throat. It has several functions, of which the most important is to maintain optimal middle-ear health. Eustachian tube dysfunction (ETD) can result in pain or a popping sensation in the ears when flying in an airplane or going up a tall building in an elevator. Many people with ETD also suffer from ear problems such as repeated middle-ear infections or fluid in the ears. However, there are very few easily-administered tests to measure and assess Eustachian tube function (ETF). Tubomanometry is one of these tests, however it is expensive and used to measure ETF only in research settings. In this study, the investigators propose that using a combination of two readily available devices, the EarPopper and a tympanometer, will work in a manner similar to a Tubomanometer to test ET function.

Interventions

  • DEVICE EarPopper
  • DEVICE Tympanometry
  • DEVICE Tubomanometry

Study Locations (1)

Pennsylvania

  • ENT Pressure Chamber Laboratory, Oakland Medical Building, 3420 Fifth Avenue, Room 118 — Pittsburgh

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2019-02-27
Est. Completion 2019-11-18

Sponsor

Cuneyt M. Alper

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03850197

The ClinicalTrials.gov registry entry for NCT03850197 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cuneyt M. Alper, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Eustachian Tube Dysfunction appearing as the primary indexed condition, and to 3 interventions — of which EarPopper is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03850197 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03850197 about?

NCT03850197 is a clinical study titled "Tubomanometry and EarPopper Devices for Eustachian Tube Function Testing". The Eustachian tube (ET) is a biological tube that links the middle ear to the back of the nose and throat. It has several functions, of which the most important is to maintain optimal middle-ear health. Eustachian tube dysfunction (ETD) can result in pain or a popping sensation in the ears when fly...

What is the current status of trial NCT03850197?

This trial is currently completed. The enrollment target is 30 participants. The study started on 2019-02-27. Estimated completion is 2019-11-18.

What conditions does trial NCT03850197 study?

This clinical trial studies the following conditions: Eustachian Tube Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03850197?

The interventions under investigation include: EarPopper (DEVICE), Tympanometry (DEVICE), Tubomanometry (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03850197?

This trial is sponsored by Cuneyt M. Alper, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03850197 being conducted?

This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial