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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: Clinical Trial Early Phase 1 study, sponsored by Cuneyt M. Alper.
NCT01925495 is a Early Phase 1 study that was terminated before completion, run by Cuneyt M. Alper. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
integrated EMG activity of tensor veli palatini muscle in response to changes in ear canal pressure and middle-ear pressure
Interventions
- OTHER varied middle-ear pressure
- DRUG varied middle-ear gas composition
- OTHER varied ear-canal pressure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2016-12-02 |
| Est. Completion | 2019-01-17 |
| Phase | Early Phase 1 |
Why NCT01925495 stopped before completion
NCT01925495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 3 interventions - of which varied middle-ear pressure is the first listed.
NCT01925495 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01925495's enrollment target sits among peer trials
32 775th of 2000 higher than 1,207 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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