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Completed

NCT Number: NCT02667301

Eustachian Tube Dysfunction Assessment

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.

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Key information

Conditions

Eustachian Tube Dysfunction

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: EMG Medelec ®Synergy

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.

Other names: TAS (Tympanic cavity Air exchange Sensor)

Tympanometer test

Device

Patient is subjected to tympanometry test on the specific ear and information is recorded.

Other names: Sonic GSI 39

Primary outcomes

  1. 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.

Secondary outcomes

  1. Amplitude in mTVP and mLVP in Microvolts

    Time frame: Test is conducted within 60 days after enrolling the patient

Other outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stratejik Yenilikci Girisimler Ltd.

Industry

Collaborators

  • Haseki Training and Research Hospital
  • The Scientific and Technological Research Council of Turkey

Registry information

Official study title

Investigation of Activities of Paratubal Muscles for Opening Eustachian Tube as Assessed by Simultaneous Electromyography and Tympanic Air Exchange Observations

Acronym: ETDA

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jan 28, 2016
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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