Eustachian Tube Dysfunction Assessment
Condition: Eustachian Tube Dysfunction
Study type: Interventional

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.
    

Intervention name(s): EMG recording; Tympanic Cavity Air Exchange Test; Tympanometer test
Intervention type(s): Device; Device; Device
Intervention description(s): 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 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.; Patient is subjected to tympanometry test on the specific ear and information is recorded.
Other intervention name(s): EMG Medelec ®Synergy; TAS (Tympanic cavity Air exchange Sensor); Sonic GSI 39
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic