Eustachian Tube DysfunctionETDANCT02667301
Eustachian Tube Dysfunction Assessment
A study testing EMG recording, Tympanic Cavity Air Exchange Test and Tympanometer test in people with Eustachian Tube Dysfunction, run by Stratejik Yenilikci Girisimler Ltd..
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Eustachian Tube Dysfunction
- What is being tested?
- EMG recording, Tympanic Cavity Air Exchange Test and Tympanometer test
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jan 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients are selected from outpatients visiting Department of Otolaryngology of Haseki Hospital with a mixture of healthy Eustachian tube and with Eustachian Tube Dysfunction problem who agreed to participate in the study after being informed and signed the consent form. Questionnaire (ETDQ-7) is used for initial determination of those with and without ET dysfunction problem to include the sufficient number of patients with ETD problem in the batch.
Who cannot join
- All of the subjects had an examination of the tympanic membrane, middle ear, nasal cavity and nasopharynx.
- Patients with severe septal deformities, nasal polyps and turbinate hypertrophy, adenoid and other nasopharyngeal masses were excluded.
- Patients with upper respiratory tract infections, acute otitis media, tympanosclerosis, otosclerosis and those who had previous ear surgery were not included in the study group.
About this study
Official title: Investigation of Activities of Paratubal Muscles for Opening Eustachian Tube as Assessed by Simultaneous Electromyography and Tympanic Air Exchange Observations
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.
Read the detailed description
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.
- Conditions
- Eustachian Tube Dysfunction
- Being tested
- EMG recording, Tympanic Cavity Air Exchange Test, Tympanometer test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EMG recordingDevice
Also called EMG Medelec ®Synergy
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.
Tympanic Cavity Air Exchange TestDevice
Also called TAS (Tympanic cavity Air exchange Sensor)
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.
Tympanometer testDevice
Also called Sonic GSI 39
Patient is subjected to tympanometry test on the specific ear and information is recorded.
| Study group | Role | What they receive |
|---|---|---|
| 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:
1. The patient is subjected to tympanometry test on the specific ear,
2. The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded,
3. The patient is hooked up to EMG instrument and TAS test equipment simultaneously and signals are recorded by both instruments for a duration of 150-300 seconds while the patient is at rest without sipping water. The patient is allowed to swallow during the test. Receives: Device: EMG recording; Device: Tympanic Cavity Air Exchange Test; Device: Tympanometer test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Latency Between mLVP and mTVP Signals
The time difference between mLVP and mTVP signals. This is an indication of synchronization of muscle activities.
Measured: Test is conducted within 60 days after enrolling the patient
Secondary outcomes (1)
Amplitude in mTVP and mLVP in Microvolts
Measured: Test is conducted within 60 days after enrolling the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startJan 2014
- Primary completionNov 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Eustachian Tube DysfunctionStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stratejik Yenilikci Girisimler Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Haseki Training and Research Hospital, The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Murat Haluk Ozkul, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667301
- Sponsor's protocol ID
- ETDA-1
- Acronym
- ETDA
- Status last verified
- Apr 2021
- First submitted
- 15 Jan 2016
- Last updated
- 20 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: IPD for all participants are available
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Activities of Paratubal Muscles for Opening Eustachian Tube as Assessed by Simultaneous Electromyography and Tympanic Air Exchange Observations
- ClinicalTrials.gov ID
- NCT02667301
- Acronym / sponsor ID
- ETDA / ETDA-1
- Conditions
- Eustachian Tube Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Stratejik Yenilikci Girisimler Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Haseki Training and Research Hospital, The Scientific and Technological Research Council of Turkey
- Study start
- Jan 2014
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Posted 20 Apr 2021
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 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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EMG, TAS and tympanometry | Experimental | Device: EMG recording, Device: Tympanic Cavity Air Exchange Test, Device: Tympanometer testAll 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: 1. The patient is subjected to tympanometry test on the specific ear, 2. The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded, 3. The patient is hooked up to EMG instrument and TAS test equipment simultaneously and signals are recorded by both instruments for a duration of 150-300 seconds while the patient is at rest without sipping water. The patient is allowed to swallow during the test. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients are selected from outpatients visiting Department of Otolaryngology of Haseki Hospital with a mixture of healthy Eustachian tube and with Eustachian Tube Dysfunction problem who agreed to participate in the study after being informed and signed the consent form. Questionnaire (ETDQ-7) is used for initial determination of those with and without ET dysfunction problem to include the sufficient number of patients with ETD problem in the batch.
Key exclusion criteria (3 listed)
- All of the subjects had an examination of the tympanic membrane, middle ear, nasal cavity and nasopharynx.
- Patients with severe septal deformities, nasal polyps and turbinate hypertrophy, adenoid and other nasopharyngeal masses were excluded.
- Patients with upper respiratory tract infections, acute otitis media, tympanosclerosis, otosclerosis and those who had previous ear surgery were not included in the study group.
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 |
|---|---|---|
| EMG recordingAlso: EMG Medelec ®Synergy1.3X0.4 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. | Device | EMG, TAS and tympanometry |
| Tympanic Cavity Air Exchange TestAlso: TAS (Tympanic cavity Air exchange Sensor)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. | Device | EMG, TAS and tympanometry |
| Tympanometer testAlso: Sonic GSI 39Patient is subjected to tympanometry test on the specific ear and information is recorded. | Device | EMG, TAS and tympanometry |
Primary outcome
Latency Between mLVP and mTVP Signals
Time frame: Test is conducted within 60 days after enrolling the patient
The time difference between mLVP and mTVP signals. This is an indication of synchronization of muscle activities.
1 secondary outcome
Amplitude in mTVP and mLVP in Microvolts
Time frame: Test is conducted within 60 days after enrolling the patient
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. IPD for all participants are available
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing EMG recording, Tympanic Cavity Air Exchange Test and Tympanometer test in people with Eustachian Tube Dysfunction, run by Stratejik Yenilikci Girisimler Ltd..
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 3 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 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 20 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Latency Between mLVP and mTVP Signals (time frame: Test is conducted within 60 days after enrolling the patient). 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 20 Apr 2021.