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Procedure

Balloon Dilation for Eustachian Tube Dysfunction

N/A
Recruiting
Led By Justin Lui, MD, FRCSC
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention
Awards & highlights

Study Summary

This trial is investigating balloon dilation of the eustachian tube to treat eustachian tube dysfunction, and participants will complete questionnaires and assessments before and after the procedure.

Who is the study for?
This trial is for individuals with persistent eustachian tube dysfunction who haven't improved after using nasal sprays or decongestants, or those experiencing barotitis media symptoms regularly. Participants must have documented ear drum movement issues and a history of related symptoms like ear pain, pressure, hearing changes, tinnitus, or vertigo.Check my eligibility
What is being tested?
The study tests if balloon dilation of the eustachian tube is more effective than a sham (placebo) procedure in treating eustachian tube dysfunction. Patients will be randomly assigned to one of the procedures and followed up with various assessments over a year.See study design
What are the potential side effects?
While re-confirming safety is part of this study's goals, potential side effects may include discomfort during the procedure, temporary hearing changes or dizziness post-procedure, and possible risk of infection similar to other ear interventions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score
Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire)
Secondary outcome measures
Ad hoc work/activity impairment questionnaire score
Change in audiogram (pure tone average thresholds)
Change in tympanogram type and pressure at peak compliance
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Balloon dilation of eustachian tubeExperimental Treatment1 Intervention
These patient will undergo balloon dilation dilation of the eustachian tube.
Group II: Sham procedurePlacebo Group1 Intervention
These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated.

Find a Location

Who is running the clinical trial?

University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,078 Total Patients Enrolled
Justin Lui, MD, FRCSCPrincipal InvestigatorUniversity of Calgary

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

To what extent is the clinical trial populated with individuals?

"Affirmative. According to clinicaltrials.gov, this study began soliciting participants on June 25th 2023 and has since sought out updates for the trial posted as recently as October 19th 2023. Currently, 76 individuals must be enrolled from 2 research sites."

Answered by AI

Is enrollment still accessible for this research program?

"Affirmative, the clinicaltrial.gov registry states that this experiment is still accepting participants. It was established on June 25th 2023 and updated October 19th 2023; 76 patients are needed at 2 different sites."

Answered by AI

What beneficial results is this trial seeking to achieve?

"This trial's primary end-goal, which will be evaluated at 6 weeks, 12 weeks, 24 weeks and 52 weeks post-intervention is to observe any changes in symptoms via an ad hoc baro-challenge ETDD symptom questionnaire. Secondary objectives consist of evaluating Change in audiogram (pure tone average thresholds) through Pure Tone Average Thresholds measured 500hz, 1khz, 2khz 4kHz 6kHz 8kHz—normal values being below 25 dB while greater readings denote poorer hearing; Airbone Gap registered at 500hz, 1KHz 2KHz 4KHZ —standard value as 0dB where higher"

Answered by AI

Who else is applying?

What site did they apply to?
Sunnybrook Health Sciences Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
Justin Lui 2023. "Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05719207.
~22 spots leftby Sep 2024
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