Eustachian Tube Dysfunction Assessment

NCT ID: NCT02667301

Last Updated: 2021-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Eustachian Tube Dysfunction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

EMG, TAS and tympanometry

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.

Group Type: EXPERIMENTAL

EMG recording

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Tympanometer test

Intervention Type: DEVICE

Patient is subjected to tympanometry test on the specific ear and information is recorded.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Tympanometer test

Patient is subjected to tympanometry test on the specific ear and information is recorded.

Intervention Type: DEVICE

Other Intervention Names

EMG Medelec ®Synergy; TAS (Tympanic cavity Air exchange Sensor); Sonic GSI 39

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haseki Training and Research Hospital

OTHER

Sponsor Role: collaborator

The Scientific and Technological Research Council of Turkey

OTHER

Sponsor Role: collaborator

Stratejik Yenilikci Girisimler Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Murat Haluk Ozkul

Head, ENT Clinic Education and Training

Responsibility Role: PRINCIPAL_INVESTIGATOR

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

ETDA-1

Identifier Type: -

Identifier Source: org_study_id