Clinical Trials Logo
  1. Home
  2. Meniere's Disease
  3. NCT04026516

CAVA: Dizziness Trial — CAVA  

Benign Paroxysmal Positional Vertigo Clinical Trial

Official title:
Production of a Device to Obtain Continuous Ambulatory Vestibular Assessment (CAVA) - Dizziness Trial

Clinical Trial Summary

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.

Clinical Trial Description

Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on our health service. There are multiple causes of dizziness, and these originate from pathologies affecting a large variety of different organ systems. Dizziness is usually episodic and short-lived, so when a patient presents to their health care provider, examination is often normal. As such, diagnosis is challenging and patients often experience significant delay in receiving a diagnosis. The investigators have developed a prototype device for monitoring dizziness and have tested it in a group of 17 healthy volunteers. The results showed that their device is capable of accurately, precisely and reliably identifying short periods of induced nystagmus (eye movements produced during dizzy attacks) among days' worth of normal eye movement data. The overall aim of this trial is to test a fully evolved device for the continuous recording of eye movements over a prolonged period of time, on patients suffering from dizziness. For the purpose of this study, the monitoring period is 23 hours a day, for 30 days. The device is composed of two components: a bespoke single-use sensor array that adheres to the participant's face, and a small reusable module that contains a battery, microcomputer, data storage facility, battery and connection port. The investigators intend to confirm that the device data can be used to identify any occurrence of nystagmus, as produced during attacks of vertigo. Each trial participant will be provided with the device and enough single-use electrode arrays to allow the array to be changed every 24 hours, for thirty days. Participants will be allowed to remove the sensor array for up to 60 minutes each day to allow them to wash and/or shower. If patients experience an episode of dizziness during the trial, they are required to log the details of the event in a trial diary. The identity of these days will not be revealed to the blinded investigator who will later conduct a formal, blinded analysis of the data. At the end of the thirty-day trial, the sensitivity and specificity of the device will be determined by assessing whether the data can be used to correctly identify the dates that participants reported dizziness. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04026516
Study type Interventional
Source Norfolk and Norwich University Hospitals NHS Foundation Trust
Contact
Status Suspended
Phase N/A
Start date July 1, 2019
Completion date May 31, 2025
View Details
See also
  Status Clinical Trial Phase
Completed NCT03425786 - Benign Paroxysmal Positional Vertigo (BPPV) Training for Sports Medicine Providers in a Pediatric Concussion Program N/A
Completed NCT02046980 - Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo Phase 2
Withdrawn NCT00978809 - Effects of Physical Treatment on Postural Stability in Benign Paroxysmal Positional Vertigo (BPPV) Patients N/A
Completed NCT02029508 - The Treatment of Posterior Semicircular Canal Benign Paroxysmal Positional Vertigo Phase 3
Completed NCT02809599 - Evidence Based Best Care Practice for Benign Paroxysmal Positional Vertigo N/A
Completed NCT03230513 - Comparison of Home-Based Exercise on the Posterior Canal Benign Paroxysmal Positional Vertigo Symptoms N/A
Completed NCT03643354 - Evaluation of the Prevalence of BPPV and Longterm Effects of Its Therapy Using the Rotundum Device in Retirement Homes N/A
Completed NCT00641797 - Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients N/A
Recruiting NCT06001047 - Head Acupuncture Treat Residual Symptoms After Canalith Repositioning Procedure for BPPV N/A
Not yet recruiting NCT04578470 - Benign Paroxysmal Positional Vertigo (BPPV) in Older Patients Phase 2
Not yet recruiting NCT04578262 - Epley Manoeuvre in Participants With Multiple Sclerosis Diagnosed From Benign Paroxysmal Positional Vertigo N/A
Completed NCT05748249 - Evaluation of the Efficacy of Vertistop® D and Vertistop® L in the Prevention of BPPV Recurrence Phase 1
Active, not recruiting NCT06314581 - Effect of a Multifaceted Educational Intervention on the Implementation of Evidence-based Practices for Benign Paroxysmal Positional Vertigo in an Emergency Department
Completed NCT04715282 - The Epley Maneuver Versus Cawthorne-Cooksey Exercises in the Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Terminated NCT03161470 - Efficacy of a Mechanical Chair for Treatment of Benign Paroxysmal Positional Vertigo (BPPV) N/A
Completed NCT05425199 - Habituation Exercises Versus Proprioceptive Training in Benign Paroxysmal Positional Vertigo N/A
Recruiting NCT05922774 - Cervical Vestibular Evoked Myogenic Potentials in Recurrent and Persistant Benign Paroxysmal Positional Vertigo
Recruiting NCT05013684 - Benign Paroxysmal Positional Vertigo in Older Adults N/A
Not yet recruiting NCT05863949 - Clinical Trial of Vit D and Calcium for Recurrent BPPV N/A
Completed NCT05127694 - Treatment In Acute Benign Paroxysmal Positional Vertigo N/A