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Vertigo, Peripheral clinical trials

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NCT ID: NCT06293989 Not yet recruiting - Vertigo, Peripheral Clinical Trials

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo

Vertigo
Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

NCT ID: NCT05863949 Not yet recruiting - Clinical trials for Vitamin D Deficiency

Clinical Trial of Vit D and Calcium for Recurrent BPPV

Start date: July 2023
Phase: N/A
Study type: Interventional

Randomized double blind placebo controlled trial of vitamin D supplements, with or without calcium supplementation, versus placebo in reduction of recurrences in BPPV.

NCT ID: NCT05516017 Not yet recruiting - Vertigo, Peripheral Clinical Trials

The Effect of Pinhole Glasses on Vestibular Electrical Stimulation

Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Balance is the ability to control and maintain the body's center of gravity within the support area. One of the important causes of imbalance is right or left sided unilateral vestibular hypofunction. Chronic vestibular hypofunction describes the loss of unilateral peripheral vestibular function lasting more than 3 months. VES is an important method for replacing the sensory afferents lost in the sudden onset of unilateral vestibular hypofunction and for the correct processing of information in the balance center. Regarding the mechanism of action of Vestibular Electrical Stimulation (VES), it is suggested that it generally affects the auditory system at various levels. Study aimed which was planned as a prospective, randomized, single-blind and single-center study, was conducted between 1 September 2022 and 1 July 2023, to Istanbul University, Istanbul Faculty of Medicine, Department of Physical Medicine and Rehabilitation, Vertigo Rehabilitation Outpatient Clinic with chronic vestibular hypofunction and the inclusion criteria. It was planned to include at least 100 matching patients. Participants who meet the inclusion criteria will be randomized into two groups by computer program after they are numbered according to the order of application. VES and exercise therapy will be applied by wearing pinhole glasses to 50 participants selected to Group 1 (G1-Experimental group). VES and exercise therapy without wearing pinhole glasses in 50 participants selected in Group 2 (G2-Control group) will be applied. Before and after the treatment, the severity of dizziness due to vestibular hypofunction, their emotional state, functionality and physical state and balance status will be evaluated. Dizziness severity will be evaluated with a visual analog scale, and emotional status, functionality and physical condition will be evaluated with the Dizziness Disability Inventory (DHI). Balance status will be determined by Tandem Gait Test, Timed Up and Go Test and Berg Balance Test. Evaluations will be made before treatment, at 1 month of treatment, and at 3 months of treatment (1 month after the end of treatment) by another study blind to treatment. With the data provided as a result of the research, it has contributed to both our country and the world literature, besides vestibular electrical stimulation, which can be used in the treatment of vestibular hypofunction, we will draw attention to the effectiveness of the use of pinhole glasses.

NCT ID: NCT04436783 Not yet recruiting - BPPV Clinical Trials

Virtual Reality Epley Maneuver System (VREMS) for Treatment of Benign Paroxysmal Positional Vertigo

Start date: November 14, 2022
Phase: N/A
Study type: Interventional

Background and Rationale: Benign paroxysmal positional vertigo (BPPV) is the most common cause of vertigo, affecting 2.4% of the general population and 30% of those over 70 years old. The main symptom is the perceived sensation of movement of the surrounding or self, without actual such movement, triggered by changes in position (positional vertigo). It can be dangerous as repetitive symptoms can lead to falls and depression, particularly in the elderly. Additionally, at least half of those with initial symptoms of BPPV will have ongoing symptoms if not treated. The Epley maneuver is a particle-repositioning maneuver that is used to treat posterior semicircular canal BPPV, the most common type of BPPV, after a diagnosis has been made on physical examination. In-office administration of the Epley maneuver by a specialist yields a 90% success rate at treating the condition; however, at-home administration is much less successful. In a previous paper we demonstrated the development and face validation of a Virtual Reality Epley Maneuver System (VREMS) for performing the Epley maneuver correctly. In this study we aim to apply VREMS treatment in patients who have been diagnosed with BPPV. Research Question and Objectives: PICO (Patient/Population Intervention Compare Outcome): In adult patients diagnosed with posterior canal BPPV by a specialist, does VREMS, as compared to self-performed Epley maneuver using an instructional handout (IH) result in improved or resolved symptoms? Methods: Vertigo patients referred to the Neurovestibular Clinic will be evaluated by an Ear, Nose and Throat (ENT) specialist. Those who are diagnosed with posterior canal BPPV after history and physical examination including the Dix-Hallpike test will be approached to be recruited into the study. Patients who consent to participating in the study will be allocated to either the VREMS cohort or the control cohort. Those in the control cohort will be provided an instructional handout (IH) to help them perform the Epley maneuver. Patients in the VREMS cohort will be provided with the VREMS device, which will help guide them through the Epley maneuver in a virtual reality environment. All participants will be asked to rate the severity of their symptoms before undergoing the Epley maneuver. Subsequently, patients will be supervised as they perform the Epley maneuver - VREMS assisted or based on reading the IH. In both groups, once the patient has performed the Epley maneuver (whether with VREMS assistance or with the IH), they will be asked to rate their symptom severity after undergoing the Epley maneuver. All patients will also be asked to complete the NASA Task Load Index (NASA-TLX) to gauge their perceived mental workload. They will also be given an opportunity to give free-text feedback. For any patient with residual BPPV symptoms following Epley maneuver with VREMS or IH, the ENT specialist/vestibular physiotherapist will perform the Epley maneuver to ensure resolution of symptoms if possible prior to discharge from the clinic. The primary outcome of the study will be the improvement in and resolution of BPPV symptoms with VREMS use as compared to IH. Secondary outcome will be mental workload in each of the study arms.