Evidence map›Paper›PMID 42310698›Full record

ArticleTrials2026

In-office balloon dilation for baro-challenge-induced Eustachian tube dysfunction: study protocol for a randomized sham-controlled trial.

Mohammad Aleinati, Jennifer L Spiegel, Trung N Le, Justin T Lui

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05719207 (Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction), which is not on this map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05719207 narecruitingnot on this map

Efficacy of Balloon Dilation of the Eustachian Tube in Eustachian Tube Dilatory Dysfunction: a Randomized, Sham-controlled Trial

TypeinterventionalSponsorUniversity of CalgaryRan2023 to 2025Enrolled76ConditionsEustachian Tube Dysfunction, BarotitisArmsBalloon dilation of eustachian tube, Sham procedure
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Mohammad AleinatiSection of Otolaryngology-Head and Neck Surgery, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.ORCID http://orcid.org/0009-0008-3685-9526
Jennifer L SpiegelDepartment of Otolaryngology - Head and Neck Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Trung N LeDepartment of Otolaryngology - Head and Neck Surgery, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada.
Justin T LuiSection of Otolaryngology-Head and Neck Surgery, Department of Surgery, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada. justin.lui@ucalgary.ca.

Funding

Campbell McLaurin in Hearing Deficiencies Award Competition (University of Calgary) 60-28850- RT756337-00000
6 · The paper itself

Abstract

backgroundBalloon dilation of the Eustachian tube (BDET) is a potential treatment for Eustachian tube dysfunction (ETD). However, high-quality evidence for its efficacy in baro-challenge-induced ETD (BCETD) is lacking. Blinded, sham-controlled trials are critical in this context, particularly given the largely subjective nature of this condition. The objective of this study protocol is to test the hypothesis that BDET is superior to a sham procedure in reducing symptoms of BCETD.

methodsThis randomized, sham-controlled, multicenter trial will be conducted at multiple tertiary care centers in Canada. Adults experiencing BCETD symptoms and have failed conservative management will be randomized to undergo BDET or a sham procedure. The BDET group will undergo in-office balloon dilation under local anesthesia, while the sham group will undergo an in-office sham procedure. The primary outcome measure is the change in BCETD symptom severity as measured by the 7-item baro-challenge-induced Eustachian tube dysfunction questionnaire (BCETDQ-7), an adapted version of the 7-Item Eustachian tube dysfunction questionnaire (ETDQ-7), at 6 weeks post-procedure. Secondary outcomes include the ETDQ-7, ability to perform a middle ear pressure equalization maneuver, health-related quality of life (EQ-5D-5L questionnaire), and subjective work and activity impairment. Outcome measures will be assessed at baseline and at 6-, 24-, and 52-weeks post-procedure. DISCUSSION: BDET may offer a minimally invasive therapeutic option for BCETD patients who fail medical management, but the lack of blinded and sham-controlled studies limits the reliability of patient-reported outcomes. This trial will offer the first blinded and sham-controlled study of BDET in the BCETD population. This design aims to reduce bias and improve the reliability of patient-reported outcomes. Upon study completion and data analysis, we intend to publish our findings in a peer-reviewed journal. If BDET is found to be effective, it may offer a novel, minimally invasive treatment option for BCETD, addressing a critical gap in management of this population.

trial registrationClinicalTrials.gov NCT05719207. Registered on 01/15/2023.

Indexed as

DilatationEar DiseasesEustachian TubeAdultCanadaDiving and Hyperbaric MedicineHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeBalloon dilation of the Eustachian tubeBalloon Eustachian tuboplastyBaro-challenge Eustachian tube dysfunctionBaro-challenge-induced Eustachian tube dysfunctionBarotitisBarotraumaEustachian tubeEustachian tube dilationEustachian tube dysfunctionRandomized clinical trial

Identifiers

PMID42310698
PMCPMC13508412

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.