Middle-ear FunctionNCT01955486
Gas Supply, Demand and Middle Ear Gas Balance -- Preliminary Protocol
A study testing flight simulation in people with Middle-ear Function, run by University of Pittsburgh at 1 site in United States.
Trial summary
The purpose of this study is to gather more information on Eustachian tube function and middle-ear pressures during flying. Ten subjects with tympanostomy tubes (plastic tubes inserted in the eardrums) in their ears or holes in their ear-drums will undergo flight simulation in a pressure chamber. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Middle-ear Function
- What is being tested?
- flight simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to 3 Apr 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult
Who may be able to join
- adults 18-50 years of age
- have unilateral or bilateral holes in the eardrums/patent tympanostomy tubes
- otherwise healthy
- ability to read and comprehend English
Who cannot join
- drainage through either tube or hole in the eardrum
- cold or allergic rhinitis on presentation
- syndrome predisposing to otitis media
- history of ossicular reconstruction
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Middle Ear Physiology Laboratory
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Gas Supply, Demand and Middle Ear Gas Balance -- Project 1, Specific Aim 4, Protocol 1
The purpose of this study is to gather more information on Eustachian tube function and middle-ear pressures during flying. Ten subjects with tympanostomy tubes (plastic tubes inserted in the eardrums) in their ears or holes in their ear-drums will undergo flight simulation in a pressure chamber. Their middle-ear pressures and Eustachian tube function will be monitored at various chamber pressures.
Read the detailed description
There are individuals who experience severe barotrauma/barotitis during airplane flights and/or free or tanked diving. Previously, one of the investigators modeled the change in middle-ear (ME) pressure during simulated airplane flights for ears with normal Eustachian tube function (ETF) and with different degrees of Eustachian tube (ET) dysfunction (Kanick SC, Doyle WJ. Barotrauma during air travel: predictions of a mathematical model. J Appl Physiol. May 2005;98(5):1592-1602). That model provided a number of important insights into the pathogenesis of ME barotrauma but included two assumptions that have not been validated: 1) in the absence of ET opening, ME pressure is relatively stable (ignoring tympanic membrane volume induced changes) over wide ranges of ambient pressures, and 2) ET periluminal pressures track local ambient pressures. Other, less rigorous, descriptions of ME pressure behavior during flight and diving make different assumptions: 1) ME pressure changes with changes in ambient pressure and 2) ambient and ET mucosa pressures are incompletely coupled. Modeling ME pressure behavior using the two sets of assumptions predicts different ME pressure trajectories and explanations for barotitis/ME barotrauma during flight and diving. Because the behavior of ME pressure during flight (or diving) constrains the interventions that could be used to prevent barotitis/ME barotrauma, it is important to determine which, if either, model is correct.
Ten otherwise healthy subjects aged 18 to 50 years with unilateral or bilateral eardrum perforations or ventilation tubes will be enrolled after obtaining Informed Consent. Complete histories will be taken with a focus on ear-related problems and they will have an ENT examination including tympanometry to document the patency of the ventilation tube and absence of drainage through the tube (disqualifiers). Eligible subjects will be studied in the pressure chamber during a typical flight simulation with periodic interruptions during ascent and descent. During the simulation, one ME will be fitted with an ear-canal probe attached to a pressure transducer and the other with a probe attached to the Forced-Response test system. ME pressure will be continuously monitored in the one ear and the Forced-Response test will be done at chamber pressures of atmospheric, on decreasing pressures (ascent in a flight) at 500 daPa intervals, during stable "cruising" cabin pressure, on increasing pressures (descent in a flight) at 500 daPa intervals and then at atmospheric pressure. All transducers will be referenced to chamber pressure and signals routed via an A-D box to the memory of a computer for on-line display and storage. Outcome variables will consist of the continuous measures of ME pressure in one ear and the periodic measures of ET opening pressure, closing pressure, passive resistance and dilatory efficiency in the contralateral ear.
Under this model, it is expected that, between active/passive ET openings, ME pressure will be relatively stable and not affected by changing chamber pressure and that the measures of ET periluminal pressures (opening pressure, closing pressure and passive resistance) will track chamber pressure.
- Conditions
- Middle-ear Function
- Being tested
- flight simulation
- Keywords
- flight simulation, middle ear, Eustachian tube function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flight simulationOther
| Study group | Role | What they receive |
|---|---|---|
| flight simulation | Experimental | flight simulation in pressure chamber Receives: Other: flight simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
middle-ear pressures
middle-ear pressure will be monitored continuously during experiment
Measured: single visit
Secondary outcomes (1)
Eustachian tube function
ETF will be measured during simulations
Measured: single visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2013 (estimated)
- Study startOct 2013
- Primary completion3 Apr 2018
- Study completion3 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Middle-ear FunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 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, Cuneyt M. Alper, University of Pittsburgh
- Investigators
- Cuneyt M Alper, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955486
- Sponsor's protocol ID
- PRO13040671-1
- Other IDs
- 2P50DC007667
- Status last verified
- Aug 2019
- First submitted
- 27 Sep 2013
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gas Supply, Demand and Middle Ear Gas Balance -- Project 1, Specific Aim 4, Protocol 1
- ClinicalTrials.gov ID
- NCT01955486
- Acronym / sponsor ID
- PRO13040671-1
- Conditions
- Middle-ear Function
- Keywords
- flight simulation, middle ear, Eustachian tube function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- Oct 2013 (actual)
- Primary completion
- 3 Apr 2018 (actual)
- Study completion
- 3 Apr 2018 (actual)
- First posted
- 7 Oct 2013 (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 purpose of this study is to gather more information on Eustachian tube function and middle-ear pressures during flying. Ten subjects with tympanostomy tubes (plastic tubes inserted in the eardrums) in their ears or holes in their ear-drums will undergo flight simulation in a pressure chamber. Their middle-ear pressures and Eustachian tube function will be monitored at various chamber pressures.
Detailed description
There are individuals who experience severe barotrauma/barotitis during airplane flights and/or free or tanked diving. Previously, one of the investigators modeled the change in middle-ear (ME) pressure during simulated airplane flights for ears with normal Eustachian tube function (ETF) and with different degrees of Eustachian tube (ET) dysfunction (Kanick SC, Doyle WJ. Barotrauma during air travel: predictions of a mathematical model. J Appl Physiol. May 2005;98(5):1592-1602). That model provided a number of important insights into the pathogenesis of ME barotrauma but included two assumptions that have not been validated: 1) in the absence of ET opening, ME pressure is relatively stable (ignoring tympanic membrane volume induced changes) over wide ranges of ambient pressures, and 2) ET periluminal pressures track local ambient pressures. Other, less rigorous, descriptions of ME pressure behavior during flight and diving make different assumptions: 1) ME pressure changes with changes in ambient pressure and 2) ambient and ET mucosa pressures are incompletely coupled. Modeling ME pressure behavior using the two sets of assumptions predicts different ME pressure trajectories and explanations for barotitis/ME barotrauma during flight and diving. Because the behavior of ME pressure during flight (or diving) constrains the interventions that could be used to prevent barotitis/ME barotrauma, it is important to determine which, if either, model is correct.
Ten otherwise healthy subjects aged 18 to 50 years with unilateral or bilateral eardrum perforations or ventilation tubes will be enrolled after obtaining Informed Consent. Complete histories will be taken with a focus on ear-related problems and they will have an ENT examination including tympanometry to document the patency of the ventilation tube and absence of drainage through the tube (disqualifiers). Eligible subjects will be studied in the pressure chamber during a typical flight simulation with periodic interruptions during ascent and descent. During the simulation, one ME will be fitted with an ear-canal probe attached to a pressure transducer and the other with a probe attached to the Forced-Response test system. ME pressure will be continuously monitored in the one ear and the Forced-Response test will be done at chamber pressures of atmospheric, on decreasing pressures (ascent in a flight) at 500 daPa intervals, during stable "cruising" cabin pressure, on increasing pressures (descent in a flight) at 500 daPa intervals and then at atmospheric pressure. All transducers will be referenced to chamber pressure and signals routed via an A-D box to the memory of a computer for on-line display and storage. Outcome variables will consist of the continuous measures of ME pressure in one ear and the periodic measures of ET opening pressure, closing pressure, passive resistance and dilatory efficiency in the contralateral ear.
Under this model, it is expected that, between active/passive ET openings, ME pressure will be relatively stable and not affected by changing chamber pressure and that the measures of ET periluminal pressures (opening pressure, closing pressure and passive resistance) will track chamber pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| flight simulation | Experimental | Other: flight simulationflight simulation in pressure chamber |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- adults 18-50 years of age
- have unilateral or bilateral holes in the eardrums/patent tympanostomy tubes
- otherwise healthy
- ability to read and comprehend English
Key exclusion criteria (4 listed)
- drainage through either tube or hole in the eardrum
- cold or allergic rhinitis on presentation
- syndrome predisposing to otitis media
- history of ossicular reconstruction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flight simulation | Other | flight simulation |
Primary outcome
middle-ear pressures
Time frame: single visit
middle-ear pressure will be monitored continuously during experiment
1 secondary outcome
Eustachian tube function
Time frame: single visit
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 7 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Middle-ear Function
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Recruiting
Wideband Tympanometry as a Non-behavioral Test of the Speech-weighted Middle Ear Transfer Function.
Conductive Hearing Loss
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.
Cuneyt M Alper, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flight simulation in people with Middle-ear Function, 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 4 inclusion and 4 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 7 Aug 2019. 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.
What does the primary outcome measure?
middle-ear pressures (time frame: single visit). It is what the study was designed to measure, not a finding.
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 7 Aug 2019.