Eustachian Tube Dysfunction Assessment (ETDA)

Stratejik Yenilikci Girisimler

Status: Completed

Conditions: Eustachian Tube Dysfunction

Treatments: Device: Tympanic Cavity Air Exchange Test; Device: Tympanometer test; Device: EMG recording

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02667301

ETDA-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

EMG, TAS and tympanometry

Experimental 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: 1. The patient is subjected to tympanometry test on the specific ear, 2. The patient is subjected to TAS test on the specific ear while sipping water and signals from ear and nasal cavity recorded, 3. 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.

Treatment:

Device: EMG recording

Device: Tympanometer test

Device: Tympanic Cavity Air Exchange Test