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Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction

ConditionsEustachian Tube DysfunctionBarotitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Balloon dilation of eustachian tube

    Device

    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

    Other intervention

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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Balloon dilation of eustachian tubeExperimental treatment 1 intervention
Group B: Sham procedureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score

Score range 1-7, with higher score indicating more severe symptoms

Time frame
6 weeks, 24 weeks, and 52 weeks post-intervention
2

Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire)

Composite of quantitative and qualitative data points

Time frame
6 weeks, 24 weeks, and 52 weeks post-intervention

Secondary outcomes

1

Change in tympanogram type and pressure at peak compliance

Change from type C to A or type B to C or type B to A is considered improvement, and vice versa is considered deterioration. Pressure at peak compliance (continuous variable, where a value of zero is normal, and more negative values indicate worse ET function).

Time frame
6 weeks, 24 weeks, and 52 weeks post-intervention
2

Change in audiogram (pure tone average thresholds)

Pure tone average thresholds measured at 500hz, 1khz, 2khz, and 4khz, where values below 25dB are normal, and higher values indicate worse hearing. Air-bone gap at 500hz, 1khz, 2khz, 4khz where normal value is 0dB, and higher values indicate worse conductive hearing.

Time frame
24 weeks
3

Improvement in ability to equalize middle ear pressure

Qualitative measure where inability to equalize middle ear pressures is a negative outcome.

Time frame
6 weeks, 24 weeks, and 52 weeks post-intervention
4

Tympanic membrane position on otoscopy

Qualitative measure where the tympanic membrane will be in a normal position, or in an abnormal retracted position.

Time frame
6 weeks, 24 weeks, and 52 weeks post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Calgary

Lead sponsor

Source ClinicalTrials.gov
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