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| Name | Class |
|---|---|
| Haseki Training and Research Hospital | OTHER |
| The Scientific and Technological Research Council of Turkey | OTHER |
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The purpose of the study is to understand the exact mechanism of the activity of paratubal muscles in opening eustachian tube in patients with the functional eustachian tube and those with the eustachian tube dysfunction problem.
In this study adult patients with normal and abnormal middle ears with documented tympanogram were tested to detect the Levator Veli Palatini (mLVP) and the tensor Veli Palatini (mTVP) electromyographic (EMG) activities corresponding to eustachian tube (ET) opening at rest. The subjects were mixed some with and some without ET dysfunction (ETD). Tests were conducted at an audiology unit at a tertiary care center located near at sea level, constant atmospheric pressure and temperature. Subjects are to be selected randomly with and without eustachian tube dysfunction (ETD) by using a questionnaire and evaluated with tympanometry and tympanic air exchange testing of the external ear canal for testing the ET openings. Monopolar and reference needle electrodes for each muscle were inserted transpalatally on the test side without topical anesthetics. Tympanic air exchange test is done by placing a pressure sensor into the external ear canal of the patient as well as a nasal pressure sensor for detecting ET openings during EMG recording. Information received from ear pressure and nasal pressure sensor of tympanic air exchange sensor (TAS) equipment was used for assessing the swallowing efficacy of the healthy subjects. Simultaneous correspondent recordings of the ET openings during the test as well as the electromyographic activity for the mLVP, mTVP were recorded.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EMG, TAS and tympanometry | Experimental | All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EMG recording | Device | 1.3X0.4 mm, sterile subdermal monopolar needle electrodes along with the same type of reference needle electrodes were inserted mTVP and mLVP muscles submucosally through the soft palate trans orally. The point of insertion for mTVP was one mm inferior and lateral of the pterygoid hamulus which is palpable at the posterior-medial of the upper alveolus. The active electrode was fully inserted horizontally into the superior belly of mTVP on the tested side. The reference electrode for mTVP was inserted into the palatine aponeurosis at one centimeter apart from the active electrode. The point of insertion for the mLVP active electrode was one centimeter medial and five mm inferior to the hamulus pterygoideus. Reference electrode of mLVP was inserted into one cm apart of medial side of the passive electrode of the mTVP at palatine aponeurosis. |
| Measure | Description | Time Frame |
|---|---|---|
| Latency Between mLVP and mTVP Signals | The time difference between mLVP and mTVP signals. This is an indication of synchronization of muscle activities. | Test is conducted within 60 days after enrolling the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Amplitude in mTVP and mLVP in Microvolts | Test is conducted within 60 days after enrolling the patient |
| Measure | Description | Time Frame |
|---|---|---|
| Observations About the Phase Relationship Between the Signal Pattern of mLVP, mTVP and Eustachian Dysfunction Problem | Any observable relationship between the signal patterns and eustachian dysfunction problem which helps to our understanding of eustachian dysfunction problem and the electrical activity of ET muscles. Common characteristics of patients with healthy and unhealthy eustachian tube. | Within 1 year |
Inclusion criteria:
Exclusion criteria:
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IPD for all participants are available
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39 enrolled participants were excluded from the study before assignment to the group because of unreliable EMG records generating wrong electrode placement for Tensor Veli Palatini and Levator Veli Palatini muscles in the soft palate.
Recruitment took place in Haseki Training and Research Hospital. An ETDQ7 questionnaire was filled out in patients who came to the Otorhinolaryngology clinic of Haseki hospital and had various ear complaints. Patients with a score of 14.5 points or greater in this quantitative test were accepted as potential "chronic eustachian dysfunction patients
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| ID | Title | Description |
|---|---|---|
| FG000 | EMG, TAS and Tympanometry | All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:
Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | EMG, TAS and Tympanometry | All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:
Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Latency Between mLVP and mTVP Signals | The time difference between mLVP and mTVP signals. This is an indication of synchronization of muscle activities. | Posted | Mean | Standard Deviation | Time in milliseconds | Test is conducted within 60 days after enrolling the patient |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | EMG, TAS and Tympanometry | All treatments were performed by the same group of professionals. EMG needle administration by an ENT specialist with 30+ year experience, EMG recording by a neurologist with 20+ year experience. Tympanic cavity Air exchange Sensor (TAS) recording is done by an experienced technician. The following are done to all patients:
Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Non-systematic Assessment | Anxiety from procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Murat Haluk Ozkul | StratejikYG | 0905327777842 | kbbhaluk@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 22, 2020 | Aug 26, 2020 | Prot_000.pdf |
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| Tympanic Cavity Air Exchange Test | Device | Tympanic cavity air exchange test is done by placing a sensitive pressure sensor in the ear canal and another pressure sensor on one of the nostrils. Patient is asked to to obstruct the other nostril with his/her index finger while holding the probe in place securely and asked to swallow the water during the next ten seconds. Both ear canal and nasal pressure values were simultaneously recorded on tympanic cavity air exchange sensor computer for subsequent analyses. The swallowing action triggers the ET opening and causes a momentary increase of pressure in the nasal cavity. ET opening moves the tympanic membrane which is sensed by the sensors. |
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| Tympanometer test | Device | Patient is subjected to tympanometry test on the specific ear and information is recorded. |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Amplitude in mTVP and mLVP in Microvolts | Posted | Mean | Standard Deviation | microvolts | Test is conducted within 60 days after enrolling the patient |
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| Other Pre-specified | Observations About the Phase Relationship Between the Signal Pattern of mLVP, mTVP and Eustachian Dysfunction Problem | Any observable relationship between the signal patterns and eustachian dysfunction problem which helps to our understanding of eustachian dysfunction problem and the electrical activity of ET muscles. Common characteristics of patients with healthy and unhealthy eustachian tube. | Not Posted | Within 1 year | Participants |
| 0 |
| 16 |
| 1 |
| 16 |
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