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Ear Diseases clinical trials

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NCT ID: NCT03587701 Recruiting - Meniere's Disease Clinical Trials

Effects of Anakinra in Subjects With Corticosteroid-resistant/Intolerant Meniere's Disease and Autoimmune Inner Ear Disease

Start date: January 3, 2019
Phase: Phase 2
Study type: Interventional

A Phase II randomized, placebo controlled study design of anakinra (Kineret) in corticosteroid-resistant or intolerant Meniere's disease (CR-MD)and corticosteroid-resistant or intolerant autoimmune inner ear disease (CR-AIED) patients. Patients will be randomized by a 2:1 allocation to anakinra or placebo for 42 continuous days. After day 42, a second placebo-controlled period will begin for an additional 42 days. This will be followed by a 264 day observation period, during which, hearing declines may be re-treated with anakinra after 30 days following the initial drug.

NCT ID: NCT03297736 Recruiting - Middle Ear Disease Clinical Trials

Improved Otologic Implants on Demand Intraoperatively With 3D CAD/CAM Autografts

Start date: March 1, 2016
Phase: N/A
Study type: Interventional

Prospectively analyze the use of 3D subtraction CAD/CAM in the operating room environment. Study participants, requiring middle ear surgery and ossicular reconstruction, will be implanted with one of two middle ear implants. The rationale is to complete a pilot study of the technology with a small number of designs. Each implant will be commonly used, in the public domain, and recreated by the CAD/CAM software.

NCT ID: NCT02482896 Recruiting - Atherosclerosis Clinical Trials

The Lolland-Falster Health Study

LOFUS
Start date: February 2016
Phase: N/A
Study type: Observational

The study is a epidemiological, cross-sectional study in a mainly rural area of Denmark in Denmark. Life expectancy is shorter, morbidity is higher, and social problems more prevalent than in the urban areas of the country. The population study aims at examining complexities of environmental, hereditary, lifestyle, and social factors as determinants and predisposing factors for morbidity, health, and quality of life. The study will cover physical, mental, and social dimensions and examine family patterns and subgroups. The study will provide baseline information for later follow-up.

NCT ID: NCT02134444 Recruiting - Dizziness Clinical Trials

Game Based Vestibular Exercise for Home Rehabilitation

Start date: May 2014
Phase: N/A
Study type: Interventional

Study Description and Purpose: The vestibular sense organs of the inner ear consist of the semi-circular canals and otolith end organs. These organs contain specialized gravito-inertial sensors that sense angular and linear head acceleration. The input from these sensors is required to stabilize gaze position during head motion, and provide an absolute frame of reference with respect to gravity, thus providing a vertical spatial reference for body orientation and balance. Disease or damage of the vestibular sense organs causes a range of distressing symptoms and functional problems for people that could include loss of balance, gaze instability, disorientation and dizziness. A novel computer based rehabilitation system with therapeutic gaming application has been developed. This method allows different gaze and head movement exercises to be coupled to a wide range of inexpensive, commercial computer games. It can be used in standing and thus graded balance demands using a sponge pad can be incorporated into the program. Study Objective: 1. Test the therapeutic effectiveness of the TRP delivered in the home compared to usual care delivered in an out-patient physical therapy clinic on measures of balance (standing and walking) , gaze control, dizziness, and health related quality of life in individuals with peripheral vestibular disorders. 2. Compare trajectory of change in electronic gaze performance measures obtained during each therapy session of each participant assigned to the home Telerehabilitation. Hypothesis: Investigators believe the Telerehabilitation platform to be a cost-effective delivery of rehabilitation. Additionally motivation to perform tedious home programs can be improved with engaging, fun and interactive computer gaming as part of the rehabilitation process. It is hypothesized the home game-based Telerehabilitation program will result in greater improvements in dynamic balance control, gaze control, and dizziness, in individuals with peripheral vestibular disorders as compared to a typical out-patient physical therapy regimen.

NCT ID: NCT01584011 Recruiting - Taste Disturbance Clinical Trials

Taste Disorders in Middle Ear Disease and After Middle Ear Surgery

Start date: January 2010
Phase: N/A
Study type: Observational

Objectives To evaluate the impact of taste disturbance in different types of chronic middle ear diseases and after middle ear surgery. Hypothesis That patients with chronic otitis media and cholesteatoma has taste disturbance already before surgery due to the disease itself, of course depending on degree of the disease. That patients with otosclerosis, has a normal nerve function before surgery. That patients with normal taste before surgery are more likely to notices a taste disturbance. That nerve in continuity after surgery, even if it is maltreated, gives less taste disturbance than a divided nerve. Methods A clinical study has been launched that measures taste function with two different methods for taste measurements, electrogustometry (EGM) and the filter paper disc method (FPD) before and after middle ear surgery in patients operated with middle ear surgery because of otosclerosis, chronic otitis media and cholesteatoma. The investigators plan to include 120 patients in this study. A parallel study of the patients own experience of the symptom has also been launched were the patients answer a questionary and a quality of life document. The investigators plan to include 300 patients in this study. A histological study where specimens of CTN from healthy ears and from ears with chronic disease will be investigated with electron microscopy has also started.