N/A N=16 Diagnostic

Eustachian Tube Dysfunction Assessment

Eustachian Tube Dysfunction

Bottom Line

View on ClinicalTrials.gov: NCT02667301 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2021

Primary outcome: Primary: Latency Between mLVP and mTVP Signals — 127.26 Time in milliseconds

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: EMG recording (Device); Tympanic Cavity Air Exchange Test (Device); Tympanometer test (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Stratejik Yenilikci Girisimler Ltd.
Primary completion: Nov 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Latency Between mLVP and mTVP Signals	127.26	—
SECONDARY Amplitude in mTVP and mLVP in Microvolts	650; 1075	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02667301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.