Recruiting

Balloon Dilation

Sponsor:

University of Calgary

Code:

NCT05719207

Conditions

Eustachian Tube Dysfunction

Barotitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Balloon dilation of eustachian tube

Sham procedure

Study Details

Brief 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. The investigators are carrying out this research study with the following goals:

1. Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction
2. Identify patient variables associated with positive response to balloon dilation of the eustachian tube
3. Re-demonstrate the safety of balloon dilation of the eustachian tube

What does participation in this study involve? Participants in this study will:

  • Agree to be randomly assigned to undergo either: balloon dilation of the eustachian tube, or a placebo procedure, with the option to undergo dilation of the eustachian tube 6 weeks later
  • Agree to allowing the investigators access to their personal health information
  • Complete the following assessments and questionnaires in clinic before undergoing balloon dilation or placebo procedure:

  • A questionnaire to assess your eustachian tube dysfunction
  • An assessment of the movement of your ear drum (tympanogram)
  • A hearing test (audiogram)
  • A questionnaire to assess the impact of eustachian tube dysfunction on work/activity
  • A questionnaire to assess overall health-related quality of life
  • An assessment of the ability to equalize middle ear pressure(s)
  • Visual examination of the ear drums
  • Repeat the above assessments and questionnaires over the course of four follow-up appointments at 6-, 24-, and 52-weeks after the procedure.

Conditions

Eustachian Tube Dysfunction

Barotitis

Study ID

NCT05719207

Start date

Jun 25, 2023

Status verified date

Mar, 2025

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (Chronic ETDD):

  • >3 months of symptoms of ETDD (otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged) persistent at enrollment
  • Persistence of symptoms despite >4 weeks INCS or >7d course of systemic steroid within 6 months from enrollment
  • Documented Type B or C tympanogram at or within 6 months from enrollment
  • ETDQ7 ≥ 2.1 at enrollment

Inclusion criteria (baro-challenge ETDD):

  • >12 months of baro-challenge induced symptoms occurring at least every 4 months within the past year
  • Symptoms include otalgia, ear pressure, muffled hearing, tinnitus, cracking or popping, feeling clogged, vertigo, or facial nerve palsy, which resolve within 3 days of pressure equalization.
  • Failure of at least one of: topical/oral decongestant, pneumatization device, and/or pressure relief ear plugs.

Exclusion Criteria:

  • Signs/symptoms of patulous eustachian tube dysfunction (autophony, tympanic membrane movement with breathing)
  • Adjunctive surgical procedure needed (ex. septoplasty, tympanostomy tube)
  • Presence of a tympanic membrane (TM) perforation or tympanostomy tube
  • Fluctuating SNHL, AOM, grade IV TM retraction, or tympanosclerosis of >50% of the TM
  • Uncontrolled sino-nasal disease, reflux, TMJ disorder, immunodeficiency, or allergies
  • Known ICA dehiscence of the bony ET of the symptomatic ear
  • Recent head and neck surgery within the past 3 months or planned procedure during study
  • History of radiation to the head and neck
  • History of craniofacial abnormality
  • Prior ET intervention
  • Psychiatric condition or cognitive impairment which precludes capacity to consent.

Study Design

Enrollment

76 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Balloon dilation of eustachian tube

These patient will undergo balloon dilation dilation of the eustachian tube.

sham comparator: Sham procedure

These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated.

Interventions

Balloon dilation of eustachian tube

Patients in the intervention group would undergo balloon dilation of the eustachian tube under local anesthetic in clinic. The Stryker XprESS LoProfile ENT dilation system or the Stryker Audion ET dilation system will be used.

Sham procedure

Patients in the sham group will undergo the motions of an in-office dilation of the eustachian tube, without actually dilating the eustachian tube.

Primary outcome measure

  • Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score [ Time Frame: 6 weeks, 24 weeks, and 52 weeks post-intervention ]
  • Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire) [ Time Frame: 6 weeks, 24 weeks, and 52 weeks post-intervention ]

Central Contacts and Locations

Central contacts

Jaimi Workun

403-764-4755jaimi.workun@albertahealthservices.ca

Mohammad Aleinati, MD

587-573-4364maleinat@ucalgary.ca

Locations

Otology Clinic, Clinic 7A, South Health Campus

Recruiting

Calgary, Alberta, Canada

Contacts

Justin Lui, MD

justin.lui@ucalgary.ca

Sunnybrook Health Sciences Center

Recruiting

Toronto, Ontario, Canada

Contacts

Trung Le, MD, PhD, FRCSC

trung.le@sunnybrook.ca

More Information

Sponsor

University of Calgary

Last update posted

Apr 3, 2025

Last verified

Mar, 2025

Keywords

  • BDET
  • ETD
  • ETDD
  • baro-challenge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2025-04-03.