ETDA: Eustachian Tube Dysfunction Assessment

Sponsor
Stratejik Yenilikci Girisimler Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT02667301
Collaborator
Haseki Training and Research Hospital (Other), The Scientific and Technological Research Council of Turkey (Other)
55
1
24

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: EMG recording
  • Device: Tympanic Cavity Air Exchange Test
  • Device: Tympanometer test
N/A

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

Study Type:
Interventional
Actual Enrollment :
55 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Investigation of Activities of Paratubal Muscles for Opening Eustachian Tube as Assessed by Simultaneous Electromyography and Tympanic Air Exchange Observations
Study Start Date :
Jan 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Jan 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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: The patient is subjected to tympanometry test on the specific ear, The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded, 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.

Device: EMG recording
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.
Other Names:
  • EMG Medelec ┬«Synergy
  • Device: Tympanic Cavity Air Exchange Test
    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.
    Other Names:
  • TAS (Tympanic cavity Air exchange Sensor)
  • Device: Tympanometer test
    Patient is subjected to tympanometry test on the specific ear and information is recorded.
    Other Names:
  • Sonic GSI 39
  • Outcome Measures

    Primary Outcome Measures

    1. Latency Between mLVP and mTVP Signals [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.

    Secondary Outcome Measures

    1. Amplitude in mTVP and mLVP in Microvolts [Test is conducted within 60 days after enrolling the patient]

    Other Outcome Measures

    1. Observations About the Phase Relationship Between the Signal Pattern of mLVP, mTVP and Eustachian Dysfunction Problem [Within 1 year]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion criteria:
    • 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.
    Exclusion criteria:
    • 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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Stratejik Yenilikci Girisimler Ltd.
    • Haseki Training and Research Hospital
    • The Scientific and Technological Research Council of Turkey

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Murat Haluk Ozkul, Head, ENT Clinic Education and Training, Haseki Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02667301
    Other Study ID Numbers:
    • ETDA-1
    First Posted:
    Jan 28, 2016
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    Participant Flow

    Recruitment Details 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
    Pre-assignment Detail 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.
    Arm/Group Title EMG, TAS and Tympanometry
    Arm/Group Description 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: The patient is subjected to tympanometry test on the specific ear, The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded, 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
    Period Title: Overall Study
    STARTED 16
    COMPLETED 14
    NOT COMPLETED 2

    Baseline Characteristics

    Arm/Group Title EMG, TAS and Tympanometry
    Arm/Group Description 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: The patient is subjected to tympanometry test on the specific ear, The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded, 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
    Overall Participants 14
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    36.2
    (12.3)
    Sex: Female, Male (Count of Participants)
    Female
    10
    71.4%
    Male
    4
    28.6%

    Outcome Measures

    1. Primary Outcome
    Title Latency Between mLVP and mTVP Signals
    Description The time difference between mLVP and mTVP signals. This is an indication of synchronization of muscle activities.
    Time Frame Test is conducted within 60 days after enrolling the patient

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title EMG, TAS and Tympanometry
    Arm/Group Description 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: The patient is subjected to tympanometry test on the specific ear, The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded, 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
    Measure Participants 16
    Mean (Standard Deviation) [Time in milliseconds]
    127.26
    (61.028420946845)
    2. Secondary Outcome
    Title Amplitude in mTVP and mLVP in Microvolts
    Description
    Time Frame Test is conducted within 60 days after enrolling the patient

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title mLVP mTVP
    Arm/Group Description Recorded amplitude of mLVP Recorded amplitude of mTVP
    Measure Participants 16 16
    Mean (Standard Deviation) [microvolts]
    650
    (211.3315816689)
    1075
    (247.71225993981)
    3. Other Pre-specified Outcome
    Title Observations About the Phase Relationship Between the Signal Pattern of mLVP, mTVP and Eustachian Dysfunction Problem
    Description 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.
    Time Frame Within 1 year

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description

    Adverse Events

    Time Frame
    Adverse Event Reporting Description
    Arm/Group Title EMG, TAS and Tympanometry
    Arm/Group Description 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: The patient is subjected to tympanometry test on the specific ear, The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded, 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
    All Cause Mortality
    EMG, TAS and Tympanometry
    Affected / at Risk (%) # Events
    Total / (NaN)
    Serious Adverse Events
    EMG, TAS and Tympanometry
    Affected / at Risk (%) # Events
    Total 0/16 (0%)
    Other (Not Including Serious) Adverse Events
    EMG, TAS and Tympanometry
    Affected / at Risk (%) # Events
    Total 1/16 (6.3%)
    Psychiatric disorders
    Anxiety 1/16 (6.3%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Murat Haluk Ozkul
    Organization StratejikYG
    Phone 0905327777842
    Email kbbhaluk@gmail.com
    Responsible Party:
    Murat Haluk Ozkul, Head, ENT Clinic Education and Training, Haseki Training and Research Hospital
    ClinicalTrials.gov Identifier:
    NCT02667301
    Other Study ID Numbers:
    • ETDA-1
    First Posted:
    Jan 28, 2016
    Last Update Posted:
    Apr 20, 2021
    Last Verified:
    Apr 1, 2021