Eustachian Tube Dysfunction Assessment

Not Applicable

Completed

• Conditions: Eustachian Tube Dysfunction
• Interventions: Device: EMG recording; Device: Tympanic Cavity Air Exchange Test; Device: Tympanometer test

• Registration Number: NCT02667301
• Lead Sponsor: Stratejik Yenilikci Girisimler Ltd.

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-11
• Study Completion: 2016-01
• Study First Submitted: 2016-01-15
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-28
• Results First Submitted: 2021-03-20
• Status Verified: 2021-04
• Results First Submitted QC: 2021-04-19
• Last Update Submitted: 2021-04-19
• Results First Posted: 2021-04-20
• Last Update Posted: 2021-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
EMG, TAS and tympanometry	EMG recording	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.
EMG, TAS and tympanometry	Tympanic Cavity Air Exchange Test	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.
EMG, TAS and tympanometry	Tympanometer test	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.

Primary Outcome Measures

Name	Time	Method
Latency Between mLVP and mTVP Signals	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 Outcome Measures

Name	Time	Method
Amplitude in mTVP and mLVP in Microvolts	Test is conducted within 60 days after enrolling the patient