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Meniere's Disease clinical trials

View clinical trials related to Meniere's Disease.

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NCT ID: NCT06001593 Recruiting - Meniere's Disease Clinical Trials

Modulating Auditory Symptoms and Vertigo of Meniere's Disease by Non-invasive Mastoid Electric Stimulation

Start date: September 7, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study is a Double-blind, Randomized, Sham-controlled, Investigator-initiated trial. To explore the effectiveness of non-invasive inner ear electrical stimulation of the mastoid behind the ear in controlling auditory symptoms and dizziness in patients with Meniere's disease.

NCT ID: NCT05984901 Recruiting - Vestibular Migraine Clinical Trials

The CAVA Multicentre Dizziness Trial

CAVA 2
Start date: April 1, 2022
Phase: N/A
Study type: Interventional

The CAVA trial is a diagnostic accuracy multicentre device trial which aims to quantify the extent to which the CAVA system can differentiate three common inner-ear causes of dizziness: Ménière's disease, vestibular migraine and Benign Paroxysmal Positional Vertigo (BPPV). The CAVA device is composed of two components: a set of bespoke single-use sensor arrays that adhere to the left and right side of the participant's face; and a small reusable module fitting over the ear that contains a battery, microcomputer data storage facility and connection ports for the arrays. The CAVA device will be worn by all participants for 30 days with the aim of capturing eye movement data during a dizzy attack. The first objective is to develop an algorithm that can discriminate between the 3 listed dizziness conditions. The second is to quantify the financial and patient benefits of deployment in the NHS. The final objective is to expedite a plan to deploy the system in the NHS.

NCT ID: NCT05938517 Completed - Ménière's Disease Clinical Trials

Pharmacokinetic Profile of Betahistine With and Without Selegiline in Healthy Volunteers

PK-BesT
Start date: June 2, 2021
Phase: Phase 1
Study type: Interventional

The goal of this pharmakokinetic trial is to demonstrate that Betahistine serum concentration is higher after combination treatment with Betahistine and Selegiline compared to Betahistine alone. The main questions it aims to answer are: Is the plasma concentration of betahistine higher due to combination treatment with selegiline compared to betahistine monotherapy? How is the safety of the combination treatment with betahistine and selegiline, the pharmacokinetics of betahistine in different dosages in blood, and the inter-individual differences in the metabolism? Subjects satisfying all selection criteria will receive three different dosages of Betahistine alone orally in ascending order (24 mg, 48 mg, 96 mg) in the first period. In the second period, subjects received Betahistine treatment as described for first period but after pre- and continuous treatment with 5 mg/ml Selegiline orally. Plasma concentration (namely the AUC0-240min) of betahistine will be measured before and 10, 30, 60, 90, 120, 180, 240 minutes after treatment with blood examinations. Safety parameters include assessment of adverse events, ECG, vital signs, laboratory measurements including kidney and liver function, full blood count and pregnancy and drug screening test.

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: NCT04438538 Completed - Ménière's Disease Clinical Trials

Ménière's Disease Registry

MDR
Start date: June 20, 2020
Phase:
Study type: Observational

Recent research has suggested that Ménière's disease may be a consequence of a number of individual conditions rather than developing from a single cause. This means that determining the different conditions that cause Ménière's disease will help the investigators to provide effective treatments. Experience from other similar medical conditions has taught the investigators that the best method to identify different causes of a condition is via a process called 'clinical subtyping'. The investigators intend to set up a large Ménière's disease database in order to allow then to subtype Ménière's disease. More specifically, the proposed project aspires to achieve two aims. The investigators intend to investigate a sub-type of Ménière's disease, bilateral disease, i.e. both ears affected. The study hopes to identify what features predict an individual developing bilateral Ménière's disease. Secondly, to test the feasibility of expanding the database across the whole of the UK to involve all Ménière's disease patients. This will allow many other features of Ménière's disease to be used to establish sub-types and help predict the best treatment for individual patients.

NCT ID: NCT04026516 Suspended - Clinical trials for Benign Paroxysmal Positional Vertigo

CAVA: Dizziness Trial

CAVA
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

Clinical investigation of a medical device (CAVA) for recording eye movements. Patients suffering from diagnosed dizziness conditions will wear the device for 23 hours a day, for 30 days. The device will capture normal eye movement data as well as data corresponding to any dizzy events experienced. At the end of the trial, the data will be downloaded and a scientist will perform a blinded analysis of the data. Specifically, they will attempt to identify the dates on which dizziness was reported.

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: NCT03325790 Completed - Meniere's Disease Clinical Trials

SPI-1005 for the Treatment of Patients With Meniere's Disease

Start date: September 28, 2017
Phase: Phase 2
Study type: Interventional

This study will evaluate the safety, efficacy, and Pharmacokinetics (PK) of two dose levels of SPI-1005 administered for 28 days compared to placebo in patients with Meniere's disease.

NCT ID: NCT02768662 Terminated - Meniere's Disease Clinical Trials

A 6-Month Extension Study of OTO-104 in Meniere's Disease

Start date: August 2016
Phase: Phase 3
Study type: Interventional

This is an open-label extension study of a single intratympanic injection of OTO-104 given every 3 months for a total of 2 injections. Subjects must have completed either Otonomy study 104-201403 (1-Year, Phase 2, Safety Study of OTO-104) or 104-201508 (Phase 3 Study of OTO-104) in order to be eligible for this open-label extension study.

NCT ID: NCT02740387 Terminated - Meniere's Disease Clinical Trials

Open Label Study of OTO-104 in Subjects With Meniere's Disease

Start date: June 2016
Phase: Phase 2
Study type: Interventional

This is a 1-year, multicenter, Phase 2, open-label safety study in subjects with unilateral Meniere's disease. Subjects will receive 1 intratympanic (IT) injection of 12 mg OTO-104 at 3-month intervals for a total of 4 injections total.