HealthyNCT00422851
Gas Supply, Demand and Middle Ear Gas Balance: Specific Aim 3c
An observational study of Healthy, run by University of Pittsburgh at 1 site in United States.
Trial summary
This study will determine if gas can pass between the environment and the middle ear by way of the eardrum. This route of gas exchange was observed in animals but has not been studied in humans. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Feb 2009
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adults 18-50 years old with at least one intact and effusion-free middle ear
Who may be able to join
- 18-50 years old
- at least one intact and effusion-free middle ear
Who cannot join
- bilateral otitis media
- 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
This study will determine if gas can pass between the environment and the middle ear by way of the eardrum. This route of gas exchange was observed in animals but has not been studied in humans. If gas exchange across the eardrum is documented and the rate is sufficiently high, this can help explain certain past observations such as why middle ear pressure does not change very much in some children and adults when they have a cold or flu. The investigators also expect that the rate of gas exchange across the eardrum will depend on whether or not the eardrum has scarred or abnormally thin regions.
Read the detailed description
Middle-ear (ME) pressure is a measure of the number of contained gas moles, and processes that addd or remove gas moles from the relatively fixed volume ME cavity change its pressure. Experimental results from animal studies document significant gas exchange across the tympanic membrane and if confirmed for humans may explain some of the paradoxical findings for children with poor Eustachian tube function such as the preservation of an aerated ME when the normal routes of gas supply are disrupted. This study measures the rates of reactive and inert gas exchange across the adult tympanic membrane with and without structural abnormalities and determines if these transfers are purely diffusive phenomena. The resulting data will be used to develop species-specific rate-constants that will be used as parameters in modeling ME pressure regulation.
- Conditions
- Healthy
- Keywords
- otitis, gas diffusion, Eustachian tube, tympanic membrane
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Normal tympanic membrane | |
| 2 | tympanosclerosis | |
| 3 | dimeric (atrophic) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJun 2007
- Study completionFeb 2009
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
- Cross-sectional
- Enrolment
- 45 participants
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 Doyle, PhD, Principal investigator, University of PittsburghJ. Douglas Swarts, PhD, Study director, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422851
- Sponsor's protocol ID
- 0609093
- Other IDs
- NIH P50DC007667
- Status last verified
- Nov 2017
- First submitted
- 12 Jan 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: Specific Aim 3c
- ClinicalTrials.gov ID
- NCT00422851
- Acronym / sponsor ID
- 0609093
- Conditions
- Healthy
- Keywords
- otitis, gas diffusion, Eustachian tube, tympanic membrane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Jun 2007
- Study completion
- Feb 2009 (actual)
- First posted
- 17 Jan 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.
This study will determine if gas can pass between the environment and the middle ear by way of the eardrum. This route of gas exchange was observed in animals but has not been studied in humans. If gas exchange across the eardrum is documented and the rate is sufficiently high, this can help explain certain past observations such as why middle ear pressure does not change very much in some children and adults when they have a cold or flu. The investigators also expect that the rate of gas exchange across the eardrum will depend on whether or not the eardrum has scarred or abnormally thin regions.
Detailed description
Middle-ear (ME) pressure is a measure of the number of contained gas moles, and processes that addd or remove gas moles from the relatively fixed volume ME cavity change its pressure. Experimental results from animal studies document significant gas exchange across the tympanic membrane and if confirmed for humans may explain some of the paradoxical findings for children with poor Eustachian tube function such as the preservation of an aerated ME when the normal routes of gas supply are disrupted. This study measures the rates of reactive and inert gas exchange across the adult tympanic membrane with and without structural abnormalities and determines if these transfers are purely diffusive phenomena. The resulting data will be used to develop species-specific rate-constants that will be used as parameters in modeling ME pressure regulation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Normal tympanic membrane |
| 2 | – | –tympanosclerosis |
| 3 | – | –dimeric (atrophic) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adults 18-50 years old with at least one intact and effusion-free middle ear
Key inclusion criteria (2 listed)
- 18-50 years old
- at least one intact and effusion-free middle ear
Key exclusion criteria (2 listed)
- bilateral otitis media
- unable to remain relaxed and quiet for up to 2 hours
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 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 2 inclusion and 2 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.