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Ear Diseases clinical trials

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NCT ID: NCT03902938 Withdrawn - Otologic Disease Clinical Trials

Use of Biodesign® Otologic Graft in Canal Wall Down Mastoidectomy: A Prospective, Randomized Trial

Start date: October 2, 2018
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized trial to evaluate canal wall down mastoidectomy (CWDM) healing outcomes using Biodesign® small intestine submucosa graft compared to autologous temporalis fascia graft.

NCT ID: NCT03852329 Terminated - Otologic Disease Clinical Trials

Feasibility of Stereotactic Image Guidance on the Lateral Skull Base

LSBN
Start date: January 1, 2020
Phase: N/A
Study type: Interventional

A clinical trial to asses the accuracy, usefulness and usability of a stereotactic image-guidance system during lateral skull base surgery.

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: NCT03421847 Completed - Depression Clinical Trials

Study of Rotatory Vestibular Tests in Major Depression Patients and Healthy Control Subjects.

Start date: July 1, 2005
Phase: N/A
Study type: Observational

This study evaluates the vestibular activity in major depression patients and healthy controls using the rotatory test and electronystagmography.

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: NCT03171181 Completed - Inner Ear Disease Clinical Trials

Unilateral Peripheral Vestibular Dysfunction: Reeducation and Spatial Orientation.

Start date: November 2013
Phase: N/A
Study type: Interventional

Motor control includes postural control and voluntary movement. For an optimal motor control it is necessary that brain integrates vestibular, visual and somatosensorial inputs properly, in a nonlinear way. Vestibular system, as an afferent organ, encodes head position in relation to gravity and changes in its linear and angular acceleration. As vestibular central system, it plays an essential role in motor control and in orientation and spatial memory as well. When a peripheral vestibular lesion occurs, elaboration, interpretation and processing of inputs are deficient and therefore motor control is altered to a greater or lesser degree. As process progress in time, there is a natural neuroplasticity that facilitates recovery or compensate vestibular function, although sometimes this process is incomplete and requires vestibular reeducation This study aims to assess changes in balance control, orientation and handicap perception in one case group with symptomatic unilateral peripheral vestibular dysfunction, before and after a rehabilitation programme (RV). To compare values obtained at the beginning and at the end of RV to those achieved by control group. Finally, this research aims to analyse evolution of spatial orientation quality in symptomatic and non symptomatic participants.

NCT ID: NCT03071003 Completed - Inner Ear Disease Clinical Trials

A Study of SENS 401 in Healthy Subjects

Start date: October 21, 2016
Phase: Phase 1
Study type: Interventional

Sensorion are the study sponsor and the objective of this study is to investigate the safety and pharmacokinetic (PK) profile of SENS 401 in humans after a single and repeat dose administration and to confirm that, there is no interconversion of the (R) enantiomer to the (S) enantiomer. The study only involves the one drug, referred to as SENS-401.The key objective is to assess the safety of SENS 401 after multiple doses in healthy subjects. The population who are eligible to take part in the study are healthy male and female, non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at Simbec. Participation in the trial will last for about 3 weeks (from first screening to final end of study visit).

NCT ID: NCT02811549 Completed - Hearing Loss Clinical Trials

Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss

Start date: November 7, 2016
Phase: N/A
Study type: Interventional

The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).

NCT ID: NCT02772796 Completed - Inner Ear Diseases Clinical Trials

A Single Dose PK Study of SENS-218 in Healthy Volunteers

Start date: February 2016
Phase: Phase 1
Study type: Interventional

This study is to aid the development for the use of SENS-218 outside its marketed therapeutic indications. SENS-218 is available in Asia and is marketed as an anti-emetic (Anti-sickness) drug often prescribed after exposure to chemotherapy. Chemotherapy exposure can often induce nausea and/or vomiting. The study only involves the one drug, referred to as SENS-218 in this study. The purpose of the study is to support the development of use of SENS-218 in non-Asian population. The key objective of this study is to identify the pharmacokinetic (PK) parameters of the drug in healthy Caucasian population. The PK refers to what the body does to the body, for example, how quickly the drug is absorbed into the blood stream. The population who are eligible to take part in the study are healthy male and female, non-smoking volunteers, aged between 18 and 50 years, as determined by screening tests at Simbec. Participation in the trial will last for about 3 weeks (from first screening visit to final end of study visit).

NCT ID: NCT02746770 Active, not recruiting - Vestibular Disorder Clinical Trials

Physiotherapy in Vestibular Disorders

Start date: February 2016
Phase: N/A
Study type: Interventional

Spanish population with unilateral peripheral vestibular disorders.