Efficacy of balloon dilation of the eustachian tube in eustachian tube dilatory dysfunction: a randomized, sham-controlled trial
Summary
This study is being conducted to learn more about a procedure, balloon dilation of the eustachian tube, in treating patients with eustachian tube dysfunction. Traditionally, eustachian tube dysfunction is treated with nasal steroid sprays and decongestants, or by placement of ear tubes. However, current evidence suggest that medical options are ineffective, and placement of ear tubes is not risk-free. Therefore, we are carrying out this research study to determine if balloon dilation of the eustachian tube is superior to a sham procedure in treating patients with eustachian tube dysfunction.
Eligibility
Eligible gender: Male, Female, Transgender, Other
Eligible ages: 18 to 120
Inclusion criteria:
There are two categories of eligible patients for this study; those with chronic eustachian tube dysfunction, and those with eustachian tube dysfunction in the context of altitude/pressure changes (baro-challenge eustachian tube dysfunction).
For those with chronic eustachian tube dysfunction, one must have at least 3 months of symptoms, failure of at least 4 weeks of intranasal steroids, documented abnormal tympanogram (specifically type As, B, or C), and they must score above or equal to 2.1 on a eustachian tube dysfunction questionnaire (ETDQ7).
For those with baro-challenge eustachian tube dysfunction, they must have had barometric-induced symptoms at least every 4 months within the last year, these symptoms must resolve within 3 days of pressure equalization, and they must have failed a trial of topical/oral decongestant, pneumatization device, or pressure relief ear plugs.
Exclusion criteria:
1. Patulous eustachian tube dysfunction
2. Presence of ear drum perforation, ear tube, or severe retraction
3. Meniere’s disease
4. Uncontrolled sinus disease, reflux, TMJ disorder, immunodeficiency, or allergies
5. Known dehiscence of the internal carotid artery in the bony eustachian tube
6. Recent head and neck surgery or planned procedure during study period
7. History of radiation to the head and neck
8. History of craniofacial abnormality
9. Prior eustachian tube intervention
10. Psychiatric condition or cognitive impairment precluding capacity to consent
Participate
Additional information
Contact information
Recruitment to this study is by PHYSICIAN REFERRAL to the office of Dr. Justin Lui (fax #403-351-3889) with an AUDIOGRAM attached. Recruitment will NOT be done by email.
Principal investigator:
Justin Lui
Clinical trial:
Yes
REB-ID:
REB22-1601