Clinical trial NCT02667301: Eustachian Tube Dysfunction Assessment
Official title: Investigation of Activities of Paratubal Muscles for Opening Eustachian Tube as Assessed by Simultaneous Electromyography and Tympanic Air Exchange Observations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Lead sponsor: Stratejik Yenilikci Girisimler Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Haseki Training and Research Hospital
name: The Scientific and Technological Research Council of Turkey
First posted: 2016-01-28
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Latency Between mLVP and mTVP Signals
timeFrame: Test is conducted within 60 days after enrolling the patient
Secondary outcomes:
measure: Amplitude in mTVP and mLVP in Microvolts
timeFrame: Test is conducted within 60 days after enrolling the patient
Other outcomes:
measure: Observations About the Phase Relationship Between the Signal Pattern of mLVP, mTVP and Eustachian Dysfunction Problem
timeFrame: Within 1 year
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