Chronic Eustachian Tube Dysfunction Clinical Trial
Official title:
Balloon Eustachian Tuboplasty in Treatment of Chronic Eustachian Tube Dysfunction
| Verified date | December 2022 |
| Source | University Hospital Ostrava |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The prevalence of Eustachian tube (ET) dysfunction in adults reaches 1%. It causes a feeling of fullness in the ear, otalgia and hearing loss and can lead to recurrent acute otitis media, development of chronic otitis media with effusion and cholesteatoma. Endoscopic transnasal balloon ET dilatation is a novel surgical technique for ET dysfunction. The main goal is to restore ET function by dilation its cartilaginous part leading to better ventilation and drainage of the middle ear. However, its real effect in the treatment of particular subgroups of patients with ET dysfunction remains unknown. Patients are mostly evaluated as one group. Adults with chronic ET dysfunction will be strictly divided into particular subgroups and included in the study. Subgroups will be compared in order to identify treatment effect in particular subgroups.
| Status | Completed |
| Enrollment | 55 |
| Est. completion date | November 30, 2020 |
| Est. primary completion date | May 31, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 99 Years |
| Eligibility | Inclusion Criteria: - adult patients with chronic Eustachian tube dysfunction lasting more than 6 months, with or without recurrence of chronic otitis media with effusion after tympanostomy Exclusion Criteria: - anatomic obstruction in nasopharynx - nasopharyngeal cancer - head and neck cancer - other middle ear surgery except for myringotomy or tympanostomy - chronic suppurative otitis media - patients who could not undergo general anesthesia - patients who did not give consent to be included in the study |
| Country | Name | City | State |
|---|---|---|---|
| Czechia | University Hospital Hradec Králové | Hradec Králové | Hradec Králové Region |
| Czechia | University Hospital Ostrava | Ostrava | Moravian-Silesian Region |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital Ostrava | University Hospital Hradec Kralove |
Czechia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Otomicro(endo)scopy | Otomicro(endo)scopy will be used to assess the presence or absence of effusion. | 36 months | |
| Secondary | Symptoms severity according to Visual Analogue Scale | Symptoms severity will be assessed on Visual Analogue Scale (on the scale of 1-10). Visual Analogue Scale is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. | 36 months | |
| Secondary | ETDQ-7 questionnaire | The patients will be asked to fill-in the Eustachian Tube Dysfunction Questionnaire in order to assess the symptoms of Eustachian Tube Dysfunction (ETD). The ETDQ-7 is a valid and reliable symptom score for use in adult patients with ETD. The ETDQ-7 tool consists of seven items with a scale of graduated responses ranging from 1 to 7, with "1" corresponding to the absence of the suggested symptom and "7", to maximum symptom severity. | 36 months | |
| Secondary | Tympanometry | Type of tympanometry curve (A, B, C) according to Joerger et al. | 36 months | |
| Secondary | Audiometry | Hearing loss according to WHO classification (mild, moderate, severe). | 36 months | |
| Secondary | Tubomanometry | Assessment of opening pressure in Eustachian tube in mmHg. | 36 months | |
| Secondary | Possibility of Valsalva and Toynbee manoeuvre | The possibility or inability of Valsalva and Toynbee manoeuvre (yes/no) | 36 months |