NCT05270031

Brief Summary

In this study, patients with dysfunction of the eustachian tube will be included. They will be randomized to one of two treatment groups.

  1. 1.balloon dilation of the eustachian tube or
  2. 2.nasal saline Patients will undergo follow-up for one year and will be able to crossover to the treatment arm after three months

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

September 8, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

September 21, 2021

Last Update Submit

September 6, 2023

Conditions

Eustachian Tube Dysfunction

Outcome Measures

Primary Outcomes (4)

  • Otoscopy, Normal, Retracted or Middle ear effusion

    Microscopic evaluation of tympanic membrane

    6 weeks

  • Otoscopy, Normal, Retracted or Middle ear effusion

    Microscopic evaluation of tympanic membrane

    3 motnths

  • Otoscopy, Normal, Retracted or Middle ear effusion

    Microscopic evaluation of tympanic membrane

    6 months

  • Otoscopy, Normal, Retracted or Middle ear effusion

    Microscopic evaluation of tympanic membrane

    12 months

Secondary Outcomes (15)

  • Valsalva maneuver -positive or negative

    6 weeks

  • Valsalva maneuver -positive or negative

    3 months

  • Valsalva maneuver -positive or negative

    6 months

  • Valsalva maneuver -positive or negative

    12 months

  • Tympanogram

    3 months

  • +10 more secondary outcomes

Study Arms (2)

Eustachian tube dilation

EXPERIMENTAL

Surgical Eustachian tube dilation in general anaesthesia

Device: Balloon dilation of the eustachian tube

Control Group

NO INTERVENTION

nasal saline spray

Interventions

Balloon dilation of the eustachian tubeDEVICE

Balloon dilation of the eustachian tube

Eustachian tube dilation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 years old (of both sexes)
  • Diagnosed with persistent obstructive eustachian tube dysfunction (OETD) for at least 3 months prior to enrolment uni- and/or bilateral
  • Diagnosis (both required):
  • i. Persistent OETD symptoms assessed by Eustachian Tube Dysfunction Questionnaire (ETDQ-7) with overall score of ≥3 (moderate to severe symptoms) for 3 months or more prior to enrollment.
  • ii. Refractory to medical therapy (minimum of 4 weeks of daily intranasal steroid spray or one completed course of an oral steroid within 3 months before study enrollment).

You may not qualify if:

  • Patulous eustachian tube
  • Prior eustachian tube intervention
  • Presence of myringotomy ventilation tube or a tympanic membrane perforation
  • Active chronic or acute otitis media
  • Chronic otitis media with cholesteatoma
  • Fluctuating sensorineural hearing loss or Meniere's disease
  • Chronic rhinosinusitis, allergies, or reflux disease not controlled with medication
  • History of head or neck surgery within 3 months
  • Prior radiation to the head and neck
  • Active temporomandibular joint disorders
  • Cleft palate or Craniofacial syndrome
  • Cystic fibrosis or Ciliary dysmotility syndrome or Systemic immunodeficiencies
  • Active acute upper respiratory infection
  • Nasal endoscopy with evidence of anatomic conditions that would prevent transnasal access to the Eustachian tube
  • CT temporal bone scan with evidence of carotid artery dehiscence, superior semicircular canal dehiscence, or extrinsic eustachian tube compression
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Center

Toronto, Ontario, Canada

Location

Related Publications (1)

  • Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.

    PMID: 40008607DERIVED

Study Officials

  • Trung N Le, MD, PhD

    Sunnybrook Health Sciences Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Cross Over after 3 months possible
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2021

First Posted

March 8, 2022

Study Start

February 24, 2022

Primary Completion

May 28, 2023

Study Completion

August 28, 2023

Last Updated

September 8, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)