Trial Outcomes & Findings for Eustachian Tube Dysfunction Assessment (NCT NCT02667301)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

Test is conducted within 60 days after enrolling the patient

Results posted on

2021-04-20

Participant Flow

Recruitment took place in Haseki Training and Research Hospital. An ETDQ7 questionnaire was filled out in patients who came to the Otorhinolaryngology clinic of Haseki hospital and had various ear complaints. Patients with a score of 14.5 points or greater in this quantitative test were accepted as potential "chronic eustachian dysfunction patients

39 enrolled participants were excluded from the study before assignment to the group because of unreliable EMG records generating wrong electrode placement for Tensor Veli Palatini and Levator Veli Palatini muscles in the soft palate.

Participant milestones

Participant milestones
Measure	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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
Overall Study Adverse Event	1
Overall Study Lack of Efficacy	1

Baseline Characteristics

Eustachian Tube Dysfunction Assessment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EMG, TAS and Tympanometry n=14 Participants 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
Age, Continuous	36.2 years STANDARD_DEVIATION 12.3 • n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	EMG, TAS and Tympanometry n=16 Participants 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.	mTVP Recorded amplitude of mTVP
Latency Between mLVP and mTVP Signals	127.26 Time in milliseconds Standard Deviation 61.028420946845	—

SECONDARY outcome

Timeframe: Test is conducted within 60 days after enrolling the patient

Outcome measures

Outcome measures
Measure	EMG, TAS and Tympanometry n=16 Participants 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.	mTVP n=16 Participants Recorded amplitude of mTVP
Amplitude in mTVP and mLVP in Microvolts	650 microvolts Standard Deviation 211.3315816689	1075 microvolts Standard Deviation 247.71225993981

OTHER_PRE_SPECIFIED outcome

Timeframe: Within 1 year

Any observable relationship between the signal patterns and eustachian dysfunction problem which helps to our understanding of eustachian dysfunction problem and the electrical activity of ET muscles. Common characteristics of patients with healthy and unhealthy eustachian tube.

Outcome measures

Outcome data not reported

Adverse Events

EMG, TAS and Tympanometry

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	EMG, TAS and Tympanometry n=16 participants at risk 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. Tympanometer test: Patient is subjected to tympanometry test on the specific ear and information is recorded.
Psychiatric disorders Anxiety	6.2% 1/16 • Number of events 1

Additional Information

Murat Haluk Ozkul

StratejikYG

Phone: 0905327777842

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place