HealthyNCT00494364
Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3a Part ii
An observational study of Healthy, run by University of Pittsburgh at 1 site in United States.
Trial summary
The middle ear is an airspace located behind the eardrum that consists of two connecting compartments. The compartment directly behind the eardrum is called the tympanum and contains the three small bones of the middle ear, the hammer, anvil and stapes, that function to transfer eardrum movements to the inner ear so… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Oct 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adult volunteers
Who may be able to join
- Both ears-drums intact and effusion-free
Who cannot join
- Chronic illness including asthma, lung, or heart disease
- Pregnant or plans on becoming pregnant during study period
- Prescription meds other than birth control
- Previous problems with inhaling nitrous oxide (e.g., during dental procedure)
- Claustrophobia in confined spaces
- Unable to remain relaxed and quiet for up to 2 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
ENT Research Center, Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Gas Supply, Demand and Middle Ear Gas Balance: Sp Aim 3a Pt ii
The middle ear is an airspace located behind the eardrum that consists of two connecting compartments. The compartment directly behind the eardrum is called the tympanum and contains the three small bones of the middle ear, the hammer, anvil and stapes, that function to transfer eardrum movements to the inner ear so that you can hear. Behind the tympanum is the mastoid cavity which is a larger airspace subdivided into small air cells of unknown function. For normal hearing, it is important that the air pressure in the middle ear is similar to that of the environment so that the eardrum can move freely in response to sounds. The air pressure of the environment is not constant and is affected by changes in weather conditions (high and low pressure systems that move through the area) and by changes in elevation above sea level (the fullness in your ears that can be noticed when you ride in an elevator or in an airplane). The air pressure in the middle ear also changes because middle ear gas is constantly leaking from that airspace to the blood that flows through the walls of the middle ear. These effects (changing environmental air pressures and changing middle ear air pressure) are independent and cause the middle ear and environmental pressures to be different from each other. Periodically and during swallowing or yawning, any existing difference between middle ear and environmental air pressure is reset to zero by the opening of a biological tube (the Eustachian tube) that connects the middle ear to the back of the nose. This allows gas flow between the middle ear and the environment which increases or decreases middle ear pressure to the level in the environment at that time. Most people cannot open their Eustachian tubes at will and the number of automatic openings varies from infrequent to often in a population. Whether or not a person's usual frequency of Eustachian openings is good enough to keep the middle ear pressure the same as environmental levels depends on how fast gas is lost from the middle ear by gas leakage (diffusion) to blood. For example, in ears with very slow rates of gas loss, the Eustachian tube does not need to open very frequently to keep the middle ear at environmental pressure. Some researchers believe that the mastoid compartment functions to control the rate of gas loss to blood, with larger mastoid volumes associated with lesser rates of middle ear gas loss. In this experiment, the investigators plan to test this by measuring mastoid and tympanum volumes using Computer tomography (CT) and the rate of blood to middle ear gas transfer using a technique that involves breathing air that contains laughing gas (Nitrous Oxide=N2O) and measuring middle ear pressure change using tympanometry (a technique that involves putting an ear plug into the ear canal and measuring the pressure). From past studies in patients undergoing short surgical or dental procedures, the investigators know that breathing gas mixtures that contain N2O will increase the blood levels of that gas, cause gas to go from blood to the middle ear and increase middle ear pressure. The investigators predict that the rate of change in middle ear pressure while breathing a gas mixture containing 25% N2O and the normal oxygen level (20%) of air will be less for those ears with larger mastoid volumes. If the investigators prediction is correct, they will be able to explain why ears with larger mastoid volumes are better able to keep their pressure like that of the environment even if the Eustachian tube does not open often.
Read the detailed description
The middle ear (ME) pressure balance is an important contributor to the maintenance of ME health. ME pressure is a measure of the number of contained gas moles and processes that add or remove gas moles from the relatively fixed volume ME cavity change its pressure. Three routes for ME gas exchange have been identified; 1) passive, gradient-dependent species exchange with the local blood via diffusion across the ME mucosa; 2) passive, gradient-dependent species exchange with the ambient environment via diffusion across the tympanic membrane, and 3) bolus exchange of mixed gases between the nasopharynx and ME during transient openings of the Eustachian tube. Total ME pressure and the trajectory of ME pressure under specified conditions depend on the relative rates of species gas exchanges across these pathways. The ME airspace can be subdivided into two compartments, the anterior tympanum and the posterior mastoid air cell system (MACS). Theory suggests that the transmucosal gas exchange rate for the ME (transMEM) may be different for the tympanum and the MACS and this possibility has important implications with respect to the role of the MACS in ME pressure regulation and protection from ME disease. This study measures the rate of inert gas exchange across the mucosa of the two ME compartments in adults. These data will be fitted to a model of gas exchange parameterized based on the relative surface areas and volumes of the two compartments, and the hypothesis that volume gas exchange across the MACS mucosa is less than that for the tympanum will be tested. The results will be used to reject or confirm one mechanism by which large MACS volume protects from otitis media under certain conditions.
- Conditions
- Healthy
- Keywords
- ear disease, otitis, Eustachian tube, mastoid air cells, Normal healthy volunteers
- Medical subject headings
- Ear Diseases, Otitis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Principal investigator, J. Douglas Swarts, University of Pittsburgh
- Investigators
- William J Doyle, PhD, Principal investigator, University of PittsburghJ. Douglas Swarts, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494364
- Sponsor's protocol ID
- PRO07040059
- Other IDs
- NIH P50DC007667
- Status last verified
- Nov 2017
- First submitted
- 28 Jun 2007
- Last updated
- 13 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Supply, Demand and Middle Ear Gas Balance: Sp Aim 3a Pt ii
- ClinicalTrials.gov ID
- NCT00494364
- Acronym / sponsor ID
- PRO07040059
- Conditions
- Healthy
- Keywords
- ear disease, otitis, Eustachian tube, mastoid air cells, Normal healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jun 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 29 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The middle ear is an airspace located behind the eardrum that consists of two connecting compartments. The compartment directly behind the eardrum is called the tympanum and contains the three small bones of the middle ear, the hammer, anvil and stapes, that function to transfer eardrum movements to the inner ear so that you can hear. Behind the tympanum is the mastoid cavity which is a larger airspace subdivided into small air cells of unknown function. For normal hearing, it is important that the air pressure in the middle ear is similar to that of the environment so that the eardrum can move freely in response to sounds. The air pressure of the environment is not constant and is affected by changes in weather conditions (high and low pressure systems that move through the area) and by changes in elevation above sea level (the fullness in your ears that can be noticed when you ride in an elevator or in an airplane). The air pressure in the middle ear also changes because middle ear gas is constantly leaking from that airspace to the blood that flows through the walls of the middle ear. These effects (changing environmental air pressures and changing middle ear air pressure) are independent and cause the middle ear and environmental pressures to be different from each other. Periodically and during swallowing or yawning, any existing difference between middle ear and environmental air pressure is reset to zero by the opening of a biological tube (the Eustachian tube) that connects the middle ear to the back of the nose. This allows gas flow between the middle ear and the environment which increases or decreases middle ear pressure to the level in the environment at that time. Most people cannot open their Eustachian tubes at will and the number of automatic openings varies from infrequent to often in a population. Whether or not a person's usual frequency of Eustachian openings is good enough to keep the middle ear pressure the same as environmental levels depends on how fast gas is lost from the middle ear by gas leakage (diffusion) to blood. For example, in ears with very slow rates of gas loss, the Eustachian tube does not need to open very frequently to keep the middle ear at environmental pressure. Some researchers believe that the mastoid compartment functions to control the rate of gas loss to blood, with larger mastoid volumes associated with lesser rates of middle ear gas loss. In this experiment, the investigators plan to test this by measuring mastoid and tympanum volumes using Computer tomography (CT) and the rate of blood to middle ear gas transfer using a technique that involves breathing air that contains laughing gas (Nitrous Oxide=N2O) and measuring middle ear pressure change using tympanometry (a technique that involves putting an ear plug into the ear canal and measuring the pressure). From past studies in patients undergoing short surgical or dental procedures, the investigators know that breathing gas mixtures that contain N2O will increase the blood levels of that gas, cause gas to go from blood to the middle ear and increase middle ear pressure. The investigators predict that the rate of change in middle ear pressure while breathing a gas mixture containing 25% N2O and the normal oxygen level (20%) of air will be less for those ears with larger mastoid volumes. If the investigators prediction is correct, they will be able to explain why ears with larger mastoid volumes are better able to keep their pressure like that of the environment even if the Eustachian tube does not open often.
Detailed description
The middle ear (ME) pressure balance is an important contributor to the maintenance of ME health. ME pressure is a measure of the number of contained gas moles and processes that add or remove gas moles from the relatively fixed volume ME cavity change its pressure. Three routes for ME gas exchange have been identified; 1) passive, gradient-dependent species exchange with the local blood via diffusion across the ME mucosa; 2) passive, gradient-dependent species exchange with the ambient environment via diffusion across the tympanic membrane, and 3) bolus exchange of mixed gases between the nasopharynx and ME during transient openings of the Eustachian tube. Total ME pressure and the trajectory of ME pressure under specified conditions depend on the relative rates of species gas exchanges across these pathways. The ME airspace can be subdivided into two compartments, the anterior tympanum and the posterior mastoid air cell system (MACS). Theory suggests that the transmucosal gas exchange rate for the ME (transMEM) may be different for the tympanum and the MACS and this possibility has important implications with respect to the role of the MACS in ME pressure regulation and protection from ME disease. This study measures the rate of inert gas exchange across the mucosa of the two ME compartments in adults. These data will be fitted to a model of gas exchange parameterized based on the relative surface areas and volumes of the two compartments, and the hypothesis that volume gas exchange across the MACS mucosa is less than that for the tympanum will be tested. The results will be used to reject or confirm one mechanism by which large MACS volume protects from otitis media under certain conditions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adult volunteers
Key inclusion criteria (1 listed)
- Both ears-drums intact and effusion-free
Key exclusion criteria (6 listed)
- Chronic illness including asthma, lung, or heart disease
- Pregnant or plans on becoming pregnant during study period
- Prescription meds other than birth control
- Previous problems with inhaling nitrous oxide (e.g., during dental procedure)
- Claustrophobia in confined spaces
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William J Doyle, PhD principal investigator
University of Pittsburgh
J. Douglas Swarts, PhD study director
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2017.