Ph.D.-Project: Eustachian Tube Dysfunction: Causes, Diagnosis, Treatment, and Prognosis

NCT05055115 | Unknown

• 1 other identifier: Niels Holm
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The Eustachian Tube (ET) is a mucosa-lined connection between the nasopharynx and the middle ear cavity. It is believed to have three functions: 1) ventilation of and pressure equalization in the middle ear cavity, 2) mucus drainage from the middle ear, and 3) protection against sound and infection from the nasopharynx1. In adults, Eustachian Tube Dysfunction (ETD) can cause complaints from one or both ears. For many years, various definitions of ETD have been used, impairing the opportunity to compare studies. However, in 2015, an international consensus on definition, types, clinical presentation, and diagnosis of ETD was published by Schilder et al2, which has been adopted by all the Scandinavian countries. The symptoms include pressure (fullness), and/or pain in the ear, muffled hearing, and overall discomfort. Furthermore, chronic ETD can result in tympanic membrane retraction, atelectasis of the middle ear cavity, and ultimately formation of cholesteatoma3. Unfortunately, the symptoms of ETD are multiple and inaccurate giving rise to varying estimates of the prevalence. As an example, a study in UK found a 0.9 % prevalence of ETD4. In addition, clear guidelines on diagnostics and treatment are not currently available due to the fact, that no objective test for detection of ETD exists. In the need of a symptom scoring system, the patient reported Eustachian Tube Dysfunction Questionnaire (ETDQ-7) has been developed and validated in English5. Yet, translation into other languages as well as validation in other settings are necessary in order to substantiate the applicability of ETDQ-7. ETD is associated with a lack of opening of ET. It is believed that the length, diameter and angle of ET influences its ability to open regularly, thus affecting its function. A short, narrow and angled ET may predispose to ETD. However, the imaging available to visualize ET are not accurate enough to diagnose ETD. A direct test of the function of ET is not available. Tubomanometry is a relatively new method developed to directly test the opening of ET, but is yet to be validated6. Both non-surgical and surgical treatment options to improve the function of the Eustachian Tube are available. Non-surgical management includes pressure equalization methods (e.g. the Valsalva maneuver), antihistamines, treatment with decongestants, and nasal douching with a saline solution. Surgically, ventilation tubes are often used to treat ETD. In case of adenoid hypertrophy obstructing the pharyngeal opening of ET, adenoidectomy is recommended. Balloon Eustachian Tuboplasty (BET) was introduced in 2010 by Ockermann et al7. BET is a non-invasive procedure performed under general anesthesia. During the procedure, a catheter is inserted either endonasally or transtympanic into ET, and a balloon is inflated with water for approximately two minutes. Various heterogeneous studies have shown a short-term effect of BET, but long-term effects are unclear8. In summary, despite the assumption of being a common condition, the field of ETD suffers from lack of precise definition, diagnostic criteria, identification of underlying causes as well as purposeful treatment, and prognostic factors. Especially, long-term effects of BET need further investigation. Therefore, in an effort to fill out the gap of knowledge about ETD, the following specific aims are proposed:

Conditions

Eustachian Tube Dysfunction; Middle Ear Disease; Hearing Loss, Conductive; Middle Ear Problem

Keywords

Balloon Eustachian Tuboplasty; Cone-beam computed tomography; CBCT; Eustachian Tube Dysfunction Questionnaire; ETDQ-7; Tubomanometry

Outcome Measures

Primary Outcomes (4)

• ETDQ-7

  ETDQ-7 score before and after tympanostomy. ETDQ-7-score varies from 7 to 49 (higher score = worse symptoms)

  Up to12 months

• Measurement of the eustachian tube

  The dimension (measured in mm) and the angle (degrees) of the Eustachian tube i measured by fusing ConeBeam CT and MRI-scans. The dimensions are then compared between groups of patients and controls.

  Up to 12 months

• Balloon Eustachian Tuboplasty

  All patients undergoing BET are registered in a database and followed for 12 months by ETDQ-7, oto-microscopy and tympanometry. The patients, who benefit from the procedure, will be compared to those without effect. Hence, the investigators hypothesize that it will be possible to assess which factors increase the probability of effect from BET in order to select patients for BET more accurately in the future. The ETDQ-7-score varies from 7 to 49 (higher score = worse symptoms)

  12 months

• R-value measured with tubomanometry in patients and controls

  Tubomanometry examines the opening of the Eustachian tube and is measured with a R-score, ranging from 0 to infinite. The R-score is grouped into three: a normal opening (R\<1), delayed opening (R\>1) and no opening R = 0. If the opening is delayed or doesn't happen, it indicates an dysfunction of the Eustachian tube. The investigators aim at examining 50 patients with ETD and compare them to 50 age- and gender matched controls to investigate the ability of tubomanometry to distinguish the two groups.

  Up to 12 months

Study Arms (1)

Balloon Eustachian Tuboplasty

EXPERIMENTAL

Patients with long-lasting symptoms of ETD, who benefits from tympanostomy tube insertion, will be offered Balloon Eustachian Tuboplasty (BET) of the cartilaginous part of ET. The procedure is performed endonasally under general anesthesia. It is believed that BET leads to micro-bleeding in the mucosa with subsequent scarring and expansion of ET.

Procedure: Balloon Eustachian Tuboplasty

Interventions

Balloon Eustachian Tuboplasty PROCEDURE

Balloon Eustachian Tuboplasty of the cartilaginous part of ET. The procedure is performed endonasally under general anesthesia. It is believed that BET leads to micro-bleeding in the mucosa with subsequent scarring and expansion of ET.

Balloon Eustachian Tuboplasty

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are included in the study if they have presented constant or intermittent ETD symptoms for more than three months:
• pressure in the ears,
• pain in the ears,
• a feeling that the ears are clogged or "under water",
• ear symptoms when having a cold or sinusitis,
• crackling or popping sound in the ears,
• ringing in the ears,
• feeling that the hearing is muffled.
• Furthermore, objective signs of negative middle ear pressure are needed:
• poorly retractable eardrum,
• tympanometry compatible with negative middle ear pressure (C2 or B-curve).

You may not qualify if:

• patient refusal to participate in the study,
• head and neck surgery in the previous three months,
• head and neck irradiation,
• ETD symptoms \<3 months,
• adenoid hypertrophy,
• nasal polyposis,
• acute upper respiratory infection or acute sinusitis,
• tympanic membrane perforation,
• age \<18 years, cleft palate,
• craniofacial syndromes including Down's Syndrome,
• cystic fibrosis,
• ciliary dysmotility syndrome.

Sponsors & Collaborators

• Regional Hospital West Jutland: lead

Study Sites (1)

Regional Hospital West Jutland

Holstebro, 7500, Denmark

RECRUITING

Related Publications (1)

• Holm NH, Ovesen T. The Usefulness of ETDQ-7 Score in Assessing ETD. Clin Otolaryngol. 2025 Sep;50(5):840-847. doi: 10.1111/coa.14324. Epub 2025 Apr 25.

  PMID: 40276950 DERIVED

MeSH Terms

Conditions

Hearing Loss, Conductive

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Niels H. Holm, MD

  Hospitalsenheden Vest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Niels H. Holm, MD

CONTACT

+4528801688; NielsHolm@gmail.com

Therese Ovesen, Professor

CONTACT

+45 5380077; theroves@rm.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Doctor of Medicine. Ph.D.-student

Model Details: 50 patients will fill out the ETDQ-7 questionnaire before and after tympanostomy. Results will be compared to 50 age- and gender matched controls with no history of ETD or ear-surgery. Both MRI and Cone Beam-CT scans are performed in order to obtain a complete overview of ET. Twelve patients with ETD and 12 healthy controls are examined with both MRI and CBCT. The dimensions and angulations of the ET in the two groups are compared to identify significant differences. Tubomanometry is a tool to measures the dynamic function of the eustachian tube. 50 patients are examinated and compared to 50 controls to investigate tubomanometry's ability to distinguish the two groups. A REDCap-database is established in order to create a national cohort where all patients undergoing first time Balloon Eustachian Tuboplasty in Denmark, are registered. All patients are followed for 12 months. The patients, who benefit from the procedure, will be compared to those without effect.

Study Record Dates

• First Submitted: August 31, 2021
• First Posted: September 24, 2021
• Study Start: June 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: November 30, 2025
• Last Updated: November 30, 2023

Record last verified: 2023-11

Locations

DK (1)