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NCT01925482 · ClinicalTrials.gov registry record · Phase 1
Trans-Middle-Ear Mucosal Gas Exchange Project 1, Specific Aim 1
A Phase 1 study of Middle Ear Gas Exchange, sponsored by Cuneyt M. Alper.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01925482: Completed Phase 1 study of Middle Ear Gas Exchange, sponsored by Cuneyt M. Alper.
NCT01925482 is a Phase 1 study of Middle Ear Gas Exchange that has completed, run by Cuneyt M. Alper. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01925482, a Phase 1 study of Middle Ear Gas Exchange, has completed, sponsored by Cuneyt M. Alper.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will measure the speed at which gases move between the middle-ear air-space and the blood flowing through the middle-ear lining. The middle ear is a rigid biological gas pocket located behind the eardrum and is filled with the same gases as in air, primarily oxygen (O), nitrogen (N) and carbon dioxide (CO2), but in different proportions. The middle ear is lined by a thin layer of cells overlying tissues that surround blood vessels. The blood that flows through the middle-ear lining also contains these same gases but at different proportions from both the atmosphere (room air) and middle ear. Because of the differences in the proportions of these gases, each gas tends to flow between the middle ear and blood trying to make the proportions of gases in those compartments the same. This flow of gases to and from the middle ear changes the middle-ear pressure. If the middle-ear pressure decreases much below the air pressure of the atmosphere, the ability to hear sounds is impaired and fluid can build up in the middle ear. It is expected that each different gas will move between the middle ear and blood at a different speed, but it is not known what those speeds are for any of the gases. It is also expected that those speeds will be different for ears that have had middle-ear disease and those that have not. In this study, we will measure the speed of nitrogen, oxygen and carbon dioxide exchanges in both directions between the middle ear and blood. To do this, the gas mixture in the middle ear will be changed so that there is movement of only one gas for each experiment and then measure the change in the amount of the gas in the middle ear. This can be done using a special instrument called a mass spectrometer if there is an open, working tympanostomy (ventilation) tube, a small plastic tube, in the eardrum. For all participants in this study, we will conduct 6 experiments lasting about 2 hours each to measure the speed of nitrogen, oxygen and carbon dioxide fl
Primary Outcome
trans-middle-ear mucosal gas exchange constants for the 3 physiological gases and 2 exchange directions will be measured at each visit (1 intervention/visit)
Conditions Studied
Interventions
- DRUG 6%CO2, 25%O2, balance N2
- DRUG 6% CO2, 0%O2, balance N2
- DRUG 20%CO2, 6%O2, balance N2
- DRUG 0%CO2, 6%O2, balance N2
- DRUG 6% CO2, 6%O2, balance N2
Study Locations (1)
Pennsylvania
- Middle Ear Physiology Laboratory, University of Pittsburgh - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2014-05-13 |
| Est. Completion | 2015-05-19 |
| Phase | Phase 1 |
What the finished NCT01925482 record still lists
NCT01925482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Middle Ear Gas Exchange appearing as the primary indexed condition, and to 5 interventions - of which 6%CO2, 25%O2, balance N2 is the first listed.
NCT01925482 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01925482 about?
NCT01925482 is a clinical study titled "Trans-Middle-Ear Mucosal Gas Exchange Project 1, Specific Aim 1". This study will measure the speed at which gases move between the middle-ear air-space and the blood flowing through the middle-ear lining. The middle ear is a rigid biological gas pocket located behind the eardrum and is filled with the same gases as in air, primarily oxygen (O), nitrogen (N) and c...
What is the current status of trial NCT01925482?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2014-05-13. Estimated completion is 2015-05-19.
What conditions does trial NCT01925482 study?
This clinical trial studies the following conditions: Middle Ear Gas Exchange.
What interventions are being tested in trial NCT01925482?
The interventions under investigation include: 6%CO2, 25%O2, balance N2 (DRUG), 6% CO2, 0%O2, balance N2 (DRUG), 20%CO2, 6%O2, balance N2 (DRUG), 0%CO2, 6%O2, balance N2 (DRUG), 6% CO2, 6%O2, balance N2 (DRUG).
Who is sponsoring clinical trial NCT01925482?
This trial is sponsored by Cuneyt M. Alper, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01925482 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01925482's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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