Eustachian Tube Dysfunction Assessment

NCT02667301 | Completed Results

• 1 other identifier: ETDA-1
• Study Type: interventional
• Target: 55
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Eustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (1)

• Latency Between mLVP and mTVP Signals

  The time difference between mLVP and mTVP signals. This is an indication of synchronization of muscle activities.

  Test is conducted within 60 days after enrolling the patient

Secondary Outcomes (1)

• Amplitude in mTVP and mLVP in Microvolts

  Test is conducted within 60 days after enrolling the patient

Other Outcomes (1)

• Observations About the Phase Relationship Between the Signal Pattern of mLVP, mTVP and Eustachian Dysfunction Problem

  Within 1 year

Study Arms (1)

EMG, TAS and tympanometry

EXPERIMENTAL

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.

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

Interventions

EMG recording 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.

Also known as: EMG Medelec ®Synergy

EMG, TAS and tympanometry

Tympanic Cavity Air Exchange Test 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.

Also known as: TAS (Tympanic cavity Air exchange Sensor)

EMG, TAS and tympanometry

Tympanometer test DEVICE

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

Also known as: Sonic GSI 39

EMG, TAS and tympanometry

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stratejik Yenilikci Girisimler Ltd.: lead
• Haseki Training and Research Hospital: collaborator
• The Scientific and Technological Research Council of Turkey: collaborator

Results Point of Contact

• Title: Murat Haluk Ozkul
• Organization: StratejikYG

kbbhaluk@gmail.com

0905327777842

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, ENT Clinic Education and Training

Study Record Dates

• First Submitted: January 15, 2016
• First Posted: January 28, 2016
• Study Start: January 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 20, 2021
• Results First Posted: April 20, 2021

Record last verified: 2021-04