Exploring causes and treatments for Eustachian Tube Dysfunction
Ph.D.-Project: Eustachian Tube Dysfunction: Causes, Diagnosis, Treatment, and Prognosis
This study is testing how to better understand and treat Eustachian Tube Dysfunction in Danish patients by looking at its causes and trying a new treatment called Balloon Eustachian Tuboplasty.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Regional Hospital West Jutland Academic / other |
| Locations | 1 site (Holstebro) |
| Trial ID | NCT05055115 on ClinicalTrials.gov |
What this trial studies
This project focuses on understanding Eustachian Tube Dysfunction (ETD) by translating and validating the Eustachian Tube Dysfunction Questionnaire (ETDQ-7) for Danish patients. It aims to investigate the anatomical causes of ETD using combined Cone-Beam CT and MRI imaging. Additionally, the study will evaluate the effectiveness of Balloon Eustachian Tuboplasty (BET) in treating chronic ETD and validate tubomanometry as a diagnostic tool. The research seeks to provide a comprehensive approach to diagnosing and treating ETD.
Who should consider this trial
Good fit: Ideal candidates are adults experiencing persistent symptoms of Eustachian Tube Dysfunction for more than three months.
Not a fit: Patients with recent head and neck surgery, acute infections, or certain anatomical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment options for patients suffering from Eustachian Tube Dysfunction.
How similar studies have performed: While the approach of validating the ETDQ-7 in Danish settings is novel, similar studies have shown success in other languages, indicating potential for effective outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients are included in the study if they have presented constant or intermittent ETD symptoms for more than three months: 1. pressure in the ears, 2. pain in the ears, 3. a feeling that the ears are clogged or "under water", 4. ear symptoms when having a cold or sinusitis, 5. crackling or popping sound in the ears, 6. ringing in the ears, 7. feeling that the hearing is muffled. Furthermore, objective signs of negative middle ear pressure are needed: 1. poorly retractable eardrum, 2. tympanometry compatible with negative middle ear pressure (C2 or B-curve). Exclusion Criteria: * 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.
Where this trial is running
Holstebro
- Regional Hospital West Jutland — Holstebro, Denmark (Recruiting)
Study contacts
- Principal investigator: Niels H. Holm, MD — Hospitalsenheden Vest
- Study coordinator: Niels H. Holm, MD
- Email: NielsHolm@gmail.com
- Phone: +4528801688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.