NCT02667301

Eustachian Tube Dysfunction Assessment

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Stratejik Yenilikci Girisimler Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
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.
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.
DEVICE	Tympanometer test	Patient is subjected to tympanometry test on the specific ear and information is recorded.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2016-01-28
• Last updated: 2021-04-20
• Results posted: 2021-04-20