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临床试验/NCT05055115
NCT05055115招募中不适用

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

Regional Hospital West Jutland2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
2
主要终点
Balloon Eustachian Tuboplasty

研究概览

简要总结

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:

详细描述

Specific Aims:

Translation, modification, and validation of the ETDQ-7 in Danish settings Investigation of combined Cone-Beam CT and MRI of the Eustachian tube in order to determine a potential anatomical cause/disposition of ETD Clarification of the effects of BET using strict criteria for ETD To validate the process of tubomanometry as an objective tool in patients with ETD

Hypothesis

ETDQ-7 is a useful patient-reported symptom scoring tool in Danish patients with assumed ETD ETD is related to the dimensions and angles of the Eustachian tube detected by combining Cone-Beat CT and MRI-scans BET is effective in patients with chronic ETD Tubomanometry can be used as an objective tool in diagnosing and monitoring the effect of treatment in patients with ETD.

Study 1:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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.

结局指标

主要结局

Balloon Eustachian Tuboplasty

时间窗: 12 months

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)

Measurement of the eustachian tube

时间窗: Up to 12 months

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.

ETDQ-7

时间窗: Up to12 months

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

R-value measured with tubomanometry in patients and controls

时间窗: Up to 12 months

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.

次要结局

未报告次要终点

研究者

发起方
Regional Hospital West Jutland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Niels Højvang Holm

Principal Investigator. Doctor of Medicine. Ph.D.-student

Regional Hospital West Jutland

研究点 (2)

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