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Ear Diseases clinical trials

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NCT ID: NCT06278129 Recruiting - Meniere Disease Clinical Trials

Evaluation of the Diagnostic and Prognostic Efficacy of MRI in Acute Sensorineural Hearing Loss and Ménière's Disease

MRI_SSHL/MD
Start date: June 19, 2018
Phase:
Study type: Observational

Evaluation of the diagnostic and prognostic efficacy of nuclear magnetic resonance imaging in patients with acute sensorineural hearing loss or in patients suffering from probable or definite MD. The neuroradiological and audiological evaluation are held on in the same day in order to better clarify the radiological and clinical correlates.

NCT ID: NCT06271694 Recruiting - Vestibular Disorder Clinical Trials

Activity and Participation in Vestibular Disorders

APV
Start date: January 1, 2024
Phase: N/A
Study type: Interventional

This study will examine whether impairments and personal factors are associated with activity and participation in people with vestibulopathy. Data collection will occur prior to starting vestibular rehabilitation and after completing vestibular rehabilitation.

NCT ID: NCT05846711 Recruiting - Vertigo Clinical Trials

The Accuracy of Manual BPPV Diagnostics When Using VNG Goggles.

Start date: April 1, 2023
Phase: N/A
Study type: Interventional

The aim is to investigate the accuracy of manual diagnostics of benign paroxysmal positional vertigo (BPPV) by comparing it to BPPV diagnostics in mechanical rotational chair (TRV chair). VNG (videonystagmography) goggles will be used in both scenarios. Furthermore, the investigators will examine the importance of angulation and velocity in relation to the diagnostic outcome.

NCT ID: NCT05353569 Recruiting - Otitis Media Clinical Trials

Coherent Optical Detection of Middle Ear Disease

OCTII
Start date: May 24, 2022
Phase: N/A
Study type: Interventional

The purpose of this project is to see if optical coherence tomography (OCT), a new technology acting as an ultrasound for the ear, facilitates accurately diagnosing acute otitis media (AOM) and otitis media with effusion (OME) in children. Clinical diagnoses made using solely pneumatic otoscopy (PO) will be compared to those made with the addition of OCT.

NCT ID: NCT05269368 Recruiting - Clinical trials for Post-Op Complication

Interest of Wicking for Ossicular Surgery and Myringoplasty

MECH-ORL
Start date: May 16, 2022
Phase: N/A
Study type: Interventional

Myringoplasties and ossicular surgery are very common procedures. Following these otological surgeries, most surgeons install a wicking. This intervention consists of placing a wick, absorbable or not, in the external acoustic meatus, after having replaced the tympanomeatal flap.

NCT ID: NCT05055115 Recruiting - Clinical trials for Eustachian Tube Dysfunction

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

Start date: June 1, 2021
Phase: N/A
Study type: Interventional

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:

NCT ID: NCT04806282 Recruiting - Meniere's Disease Clinical Trials

Deep Phenotyping of Hearing Instability Disorders: Cohort Establishment, Biomarker Identification, Development of Novel Phenotyping Measures, and Discovery of Therapeutic Targets

Start date: August 17, 2021
Phase:
Study type: Observational

Background: Disorders of hearing instability (HI) are poorly characterized and ineffectively treated. HI can cause fluctuations in hearing thresholds and speech understanding. Researchers want to use a specialized form of magnetic resonance imaging (MRI) and blood tests to learn more about HI. Objective: To characterize a cohort of people with HI and to correlate HI with other data, including hearing evaluations, as well as radiologic and immunologic biomarkers of inflammation over time. Eligibility: Adults ages 18-80 who have symptoms consistent with possible HI. Design: Participants will be screened with a medical and hearing history and medical record review. Participants will have physical exams. Their head and neck will be examined. They will have blood drawn. Participants will have hearing tests. They will wear headphones or foam earplugs. They will listen to different tones. They may describe what they hear. Participants will have balance tests. They will wear goggles as they watch moving lights or while cold or warm air is blown into their ears. They will sit in a spinning chair in a quiet, dark booth. From a reclining position, they will raise their head while clicking sounds are played into their ears. Participants will have MRIs of the inner ear and brain. The MRI scanner is a metal cylinder surrounded by a strong magnetic field. During the MRIs, participants will lie on a table that slides in and out of the scanner. Soft padding or a coil will be placed around their head. They will get a contrast agent through an intravenous catheter. Participation will last up to 15 months. ...

NCT ID: NCT04804098 Recruiting - Pressure Injury Clinical Trials

Effect of Rate (Slope) of Compression on the Incidence of Symptomatic ETD and MEB: a Phase III Prospective Study.

Start date: September 20, 2021
Phase: N/A
Study type: Interventional

Eustachian tube dysfunction (ETD) and middle ear barotrauma (MEB) are common reported complications during hyperbaric oxygen treatment. The Phase I study data was the first to demonstrate a statistically significant decrease in the occurrence of symptomatic ETD and middle ear barotrauma (MEB). The Phase I Trial suggested the total time interval and rate (slope) of compression (ROC) may be a determining factor in ETD and MEB. This Phase II study investigates an optimal total time interval and rate of compression to reduce ETD and MEB when considering each multiplace treatment (with multiple patients) as the unit of observation collectively as a group, rather than for each individual patient. Data will be collected prospectively on group patient-treatment exposures. Our investigators randomly assign patient-treatment group exposures to two different rates (slopes) of compression. These are limited to the linear versus the non-linear rates (slopes) of compression identical to two of four compression profiles used in the Phase I and Phase II trials. All patients experiencing symptoms of ETD and MEB requiring compression stops will be evaluated post treatment to confirm the presence of ETD and MEB using the O'Neill Grading System (OGS). Data will be analyzed using the IBM-SPSS statistical software program. The number of compression holds observed in each of the compression schedules/compression profiles using an identical 15-minute total time interval of compression but varying in the rate (slope) of compression will be recorded as in the Phase I and II studies. Symptomatic patients who required compression stops (as in the Phase I trial) using a USN TT 9 during elective hyperbaric oxygen treatments in a Class A multiplace hyperbaric chamber will be compared. Statistical analysis using descriptive and Inferential statistics will be applied to the patients requiring first stops in the compression profiles. This will be used to further evaluate the data restricted to the rate of compression (linear vs. non-linear) and whether this is associated with the number of compression holds. The 15-minute total time interval of compression will be identical in both compression profiles studied since this was found to be the total time interval of compression with the least number of treatment stops/holds in the phase I and phase II studies.

NCT ID: NCT04803279 Recruiting - Clinical trials for Conductive Hearing Loss

Investigating Hearing With Ponto 3 SuperPower, a Bone Anchored Hearing Aid - Investigating Hear

Start date: March 16, 2021
Phase:
Study type: Observational

The study is part of the Post Market Clinical Follow (PMCF) activity. The investigational device is the CE-marked Ponto 3 SuperPower (available on the market since December 2016) already fitted to the subjects, and data is collected retrospectively from clinical routine visits. The study is a retrospective study. Therefore there will be no study visits for treatment or follow-up in the study. Subject inclusion for this clinical investigation will be performed among subjects who has been fitted with the Ponto 3 SuperPower. To have a wide representative selection of subjects, enrollment will be spread over the 4 years since the device was available on the market since December 2016. The endpoints in the study will investigate the improvement of hearing with the Ponto 3 SuperPower. The data will be collected from the subjects in the time period from the clinical routine visit where the Ponto 3 SuperPower where fitted or just prior, and from the clinical routine visit following the fitting, where audiologic fitting follow-up procedures are performed (approximately 3 months).

NCT ID: NCT04328181 Recruiting - Clinical trials for Coronary Artery Disease

Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)

SPEQUA
Start date: January 29, 2021
Phase: N/A
Study type: Interventional

This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection. Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints, earl/temporal bone, colorectal carcinosis.