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

Primary Purpose

Eustachian Tube Dysfunction, Barotitis

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Balloon dilation of eustachian tube (Stryker XprESS LoProfile ENT dilation system)
Sham procedure
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eustachian Tube Dysfunction focused on measuring BDET, ETD, ETDD, baro-challenge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Otology Clinic, Clinic 7A, South Health CampusRecruiting
  • Sunnybrook Health Sciences CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Balloon dilation of eustachian tube

Sham procedure

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score
Score range 1-7, with higher score indicating more severe symptoms
Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire)
Composite of quantitative and qualitative data points

Secondary Outcome Measures

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).
Change in audiogram (pure tone average thresholds)
Pure tone average thresholds measured at 500hz, 1khz, 2khz, 4khz, 6khz, and 8khz, 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.
Improvement in ability to equalize middle ear pressure
Qualitative measure where inability to equalize middle ear pressures is a negative outcome.
Tympanic membrane position on otoscopy
Qualitative measure where the tympanic membrane will be in a normal position, or in an abnormal retracted position.
Ad hoc work/activity impairment questionnaire score
Score range 1-7, with higher score indicating more severe symptoms

Full Information

First Posted
January 15, 2023
Last Updated
October 19, 2023
Sponsor
University of Calgary
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1. Study Identification

Unique Protocol Identification Number
NCT05719207
Brief Title
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction
Official Title
Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction: a Randomized, Sham-controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2023 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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: Determine if balloon dilation of the eustachian tube is superior to a placebo procedure in treating patients with eustachian tube dilatory dysfunction Identify patient variables associated with positive response to balloon dilation of the eustachian tube 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-, 12-, 24-, and 52-weeks after the procedure.
Detailed Description
Adult eustachian tube dilatory dysfunction (ETDD) accounts for over 2 million healthcare visits annually. It can cause longstanding negative middle ear pressure which may lead to otitis media with effusion, tympanic membrane retraction, perforation, middle ear atelectasis and cholesteatoma. Despite this, effective treatments for ETDD are unavailable. Recently, balloon dilation of the eustachian tube (BDET) has gained popularity, where the cartilaginous portion of the Eustachian tube undergoes local dilation with balloon inflation. This technique underwent industry-funded clinical trials in the United States demonstrating its safety and it's superiority to medical management. However, these studies are confounded by industry funding and lack of a blinded control group, the latter of which is critical in a condition where patient-reported outcome measures are relied on. Furthermore, the randomized studies to date do not include patients with baro-challenge ETDD, where symptoms are limited to the context of ambient pressure changes. As such, the investigators opted to perform a non-industry-funded, placebo-controlled trial including both chronic and baro-challenge ETDD patients in a Canadian setting. Potential participants will be identified as possible study candidates with either chronic ETDD or baro-challenge ETDD, who have failed conservative management. At baseline, participants would undergo pure tone audiometry, tympanometry, and otoscopy. An ETDQ7, ad hoc work/activity impairment questionnaire, and EQ-5D-5L questionnaire would be completed. The patient's ability to equalize their middle ear pressure would be assessed by direct visualization of the tympanic membrane as the patient equalizes their middle ear pressure. For patients with baro-challenge ETDD, a baseline ad hoc questionnaire to quantify their symptoms will be completed as well. Patients would then be randomized into BDET versus placebo groups. Patients in the experimental group undergoing BDET in-office will undergo dilation after anxiolytic pre-medication, nasal decongestion, as well as topical anesthesia of the lateral tympanic membrane, the eustachian tube orifice, and the nasal cavity. Patients randomized to the placebo group would undergo a similar procedure in-office, but without dilation of the eustachian tube. Patients in the experimental group with contraindication to in-office BDET will undergo BDET under general anesthetic in an operating room setting. The participants' first follow-up visit with the surgeon is at 6 weeks post-procedure, where patients in the placebo control group would be offered the option to cross-over into the BDET group. Follow up would also be repeated at 12 weeks, 24 weeks, and 52 weeks post-procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eustachian Tube Dysfunction, Barotitis
Keywords
BDET, ETD, ETDD, baro-challenge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel design with optional crossover from control to intervention at 6 weeks.
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Balloon dilation of eustachian tube
Arm Type
Experimental
Arm Description
These patient will undergo balloon dilation dilation of the eustachian tube.
Arm Title
Sham procedure
Arm Type
Sham Comparator
Arm Description
These patients will undergo a sham procedure, where the motions of balloon dilation of the eustachian tube will be simulated.
Intervention Type
Device
Intervention Name(s)
Balloon dilation of eustachian tube (Stryker XprESS LoProfile ENT dilation system)
Other Intervention Name(s)
Stryker XprESS LoProfile ENT dilation system (Stryker ENT, Plymouth, MN, USA.)
Intervention Description
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 will be used. Participants may undergo dilation under general anesthesia if a contraindication to in-clinic dilation exists.
Intervention Type
Other
Intervention Name(s)
Sham procedure
Intervention Description
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 Information:
Title
Change in mean Eustachian Tube Dysfunction Questionnaire (ETDQ7) score
Description
Score range 1-7, with higher score indicating more severe symptoms
Time Frame
6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention
Title
Change in symptoms (ad hoc baro-challenge ETDD symptom questionnaire)
Description
Composite of quantitative and qualitative data points
Time Frame
6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention
Secondary Outcome Measure Information:
Title
Change in tympanogram type and pressure at peak compliance
Description
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, 12 weeks, 24 weeks, and 52 weeks post-intervention
Title
Change in audiogram (pure tone average thresholds)
Description
Pure tone average thresholds measured at 500hz, 1khz, 2khz, 4khz, 6khz, and 8khz, 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
Title
Improvement in ability to equalize middle ear pressure
Description
Qualitative measure where inability to equalize middle ear pressures is a negative outcome.
Time Frame
6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention
Title
Tympanic membrane position on otoscopy
Description
Qualitative measure where the tympanic membrane will be in a normal position, or in an abnormal retracted position.
Time Frame
6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention
Title
Ad hoc work/activity impairment questionnaire score
Description
Score range 1-7, with higher score indicating more severe symptoms
Time Frame
6 weeks, 12 weeks, 24 weeks, and 52 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jaimi Workun
Phone
403-764-4755
Ext
4
Email
jaimi.workun@albertahealthservices.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Mohammad Aleinati, MD
Phone
587-573-4364
Email
maleinat@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Justin Lui, MD, FRCSC
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Otology Clinic, Clinic 7A, South Health Campus
City
Calgary
State/Province
Alberta
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justin Lui, MD
Email
justin.lui@ucalgary.ca
Facility Name
Sunnybrook Health Sciences Center
City
Toronto
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trung Le, MD, PhD, FRCSC
Email
trung.le@sunnybrook.ca

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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