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NCT01925495 · ClinicalTrials.gov registry record · Early Phase 1

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

A Early Phase 1 study, sponsored by Cuneyt M. Alper.

Terminated
Registry status
Early Phase 1
Development phase
32
Enrollment target

NCT01925495 is a Early Phase 1 study that was terminated before completion, run by Cuneyt M. Alper. The registered enrollment target is 32 participants.

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The verdict

NCT01925495, a Early Phase 1 study, was terminated before completion, sponsored by Cuneyt M. Alper.

TERMINATED
Registry status
Early Phase 1
Development phase
32 participants
Enrollment target

Study Summary

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.

Interventions

  • OTHER varied middle-ear pressure
  • DRUG varied middle-ear gas composition
  • OTHER varied ear-canal pressure

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2016-12-02
Est. Completion 2019-01-17
Phase Early Phase 1

Sponsor

Cuneyt M. Alper

5 total trials

What the Registry Record Tells You About NCT01925495

The ClinicalTrials.gov registry entry for NCT01925495 describes a study currently listed as terminated, categorized as Early Phase 1. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cuneyt M. Alper, which has 5 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which varied middle-ear pressure is the first listed.

NCT01925495 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01925495 about?

NCT01925495 is a clinical study titled "Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3". 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 usuall...

What is the current status of trial NCT01925495?

This trial is currently terminated. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2016-12-02. Estimated completion is 2019-01-17.

What interventions are being tested in trial NCT01925495?

The interventions under investigation include: varied middle-ear pressure (OTHER), varied middle-ear gas composition (DRUG), varied ear-canal pressure (OTHER).

Who is sponsoring clinical trial NCT01925495?

This trial is sponsored by Cuneyt M. Alper, which has 5 total clinical trials registered on ClinicalTrials.gov.

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

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