Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3

ClinicalTrials.gov ID: NCT01925495

Public ClinicalTrials.gov record NCT01925495. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

Middle Ear Pressure Regulation in Health and Disease/Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a study to determine if there are reflexes that detect changes in eardrum position or in the pressure of middle-ear gases and respond with changes in the ease by which the Eustachian tube is opened. The Eustachian tube is the normal tube that connects the middle ear to the nose. It is usually closed, but can be opened by contraction of 2 small muscles that surround the tube. If the Eustachian tube does not open frequently enough, the pressure in the middle ear will decrease, the eardrum will be pulled in toward the middle ear causing a hearing loss, and fluid will accumulate in the middle ear to try and stabilize its pressure. There is some evidence that the changes in eardrum position and middle-ear pressure when the Eustachian tube does not open frequently enough can be detected by the brain that, in turn, sends signals to the Eustachian tube and its muscles to make Eustachian tube opening easier. In this study, we will test this possibility. Specifically, in 3 experiments done on 5 different days, we will move the eardrum in and out, apply different pressures to the middle ear, or change the composition of the gases in the middle ear while we measure how difficult it is to open the Eustachian tube by increasing middle-ear pressure or by measuring the "readiness" of the Eustachian tube muscles to contract and open the tube.

Study identification

NCT ID: NCT01925495
Recruitment status: Terminated
Study type: Interventional
Phase: Early Phase 1
Lead sponsor: Cuneyt M. Alper; Other
Enrollment: 32 participants

Conditions and interventions

Conditions

Middle-ear Function

Interventions

Other · Drug

Eligibility (public fields only)

Age range: 18 Years to 50 Years
Sex: All
Healthy volunteers: Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Dec 1, 2016
Primary completion: Nov 11, 2018
Completion: Jan 16, 2019
Last update posted: May 16, 2019

2016 – 2019

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Middle Ear Physiology Laboratory, University of Pittsburgh	Pittsburgh	Pennsylvania	15213	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT01925495, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 16, 2019 · Synced Sep 2, 2026

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The complete protocol, eligibility criteria, and contact information for NCT01925495 live on ClinicalTrials.gov.

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