In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups. 1. balloon dilation of the eustachian tube or 2. nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months
Patients will eustachian tube dysfunction will be asked to participate in the study. They will be randomized to one of two groups group 1 - surgical dilation of the eustachian tube in general anaesthesia group 2 - daily nasal saline spray, twice a day Regular Follow up with Tympanogram and Questionnaire After three months patient in the control group (nasal saline) can switch in the intervention group. Eustachian tube dilation will be carried out with a Health Canada and FDA approved device, usually used for endovascular balloon dilation. It has the same size and pressure properties as the eustachian tube dilation device and has shown a good safety profile in a previous preclinical and clinical pilot study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Balloon dilation of the eustachian tube
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Time frame: 6 weeks
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Time frame: 3 motnths
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Time frame: 6 months
Otoscopy, Normal, Retracted or Middle ear effusion
Microscopic evaluation of tympanic membrane
Time frame: 12 months
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Time frame: 6 weeks
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Time frame: 3 months
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Time frame: 6 months
Valsalva maneuver -positive or negative
Subjective effectiveness of Valsalva maneuver
Time frame: 12 months
Tympanogram
Measurement with tympanometer
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Time frame: 3 months
Tympanogram
Measurement with tympanometer
Time frame: 6 months
Tympanogram
Measurement with tympanometer
Time frame: 12 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Time frame: 6 weeks
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Time frame: 3 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Time frame: 6 months
ETDQ-7 (eustachian tube dilation questionnaire - seven)
Questionnaire
Time frame: 12 months
HUI (Health utility index)
Questionnaire
Time frame: 6 weeks
HUI (Health utility index)
Questionnaire
Time frame: 3 months
HUI (Health utility index)
Questionnaire
Time frame: 6 months
HUI (Health utility index)
Questionnaire
Time frame: 12 months