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An investigation into the diagnostic accuracy, reliability, acceptability and safety of a novel device for Continuous Ambulatory Vestibular Assessment (CAVA).

ABSTRACT: Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on health services. It is usually episodic and short-lived, so when a patient presents to their clinician, examination is normal. The CAVA (Continuous Ambulatory Vestibular Assessment) device has been developed to provide continuous monitoring of eye-movements, allowing insight into the physiological parameters present during a dizziness attack. This article describes the first clinical investigation into the medical and technical aspects of this new diagnostic system. Seventeen healthy subjects wore the device near continuously for up to thirty days, artificially inducing nystagmus on eight occasions. 405 days' worth of data was captured, comprising around four billion data points. A computer algorithm developed to detect nystagmus demonstrated a sensitivity of 99.1% (95% CI: 95.13% to 99.98%) and a specificity of 98.6% (95% CI: 96.54% to 99.63%). Eighty-two percent of participants wore the device for a minimum of eighty percent of each day. Adverse events were self-limiting and mostly the consequence of skin stripping from the daily replacement of the electrodes. The device was shown to operate effectively as an ambulatory monitor, allowing the reliable detection of artificially induced nystagmus.

SUBMITTER: Phillips JS

PROVIDER: S-EPMC6639326 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature

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An investigation into the diagnostic accuracy, reliability, acceptability and safety of a novel device for Continuous Ambulatory Vestibular Assessment (CAVA).

Phillips John S JS Newman Jacob L JL Cox Stephen J SJ

Scientific reports 20190718 1

Dizziness is a common condition that is responsible for a significant degree of material morbidity and burden on health services. It is usually episodic and short-lived, so when a patient presents to their clinician, examination is normal. The CAVA (Continuous Ambulatory Vestibular Assessment) device has been developed to provide continuous monitoring of eye-movements, allowing insight into the physiological parameters present during a dizziness attack. This article describes the first clinical ...[more]

PMID: 31320726

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Project description:BackgroundAthletes can experience exercise-induced transient arrythmias during high-intensity exercise or competition, which are difficult to capture on traditional Holter monitors or replicate in clinical exercise testing. The aim of this study was to investigate the reliability of a portable single channel ECG sensor and data recorder (PluxECG) and to evaluate the confidence and reliability in interpretation of ECGs recorded using the PluxECG during remote rowing.MethodsThis was a two-phase study on rowing athletes. Phase I assessed the accuracy and precision of heart rate (HR) using the PluxECG system compared to a reference 12-lead ECG system. Phase II evaluated the confidence and reliability in interpretation of ECGs during ergometer (ERG) and on-water (OW) rowing at moderate and high intensities. ECGs were reviewed by two expert readers for HR, rhythm, artifact and confidence in interpretation.ResultsFindings from Phase I found that 91.9% of samples were within the 95% confidence interval for the instantaneous value of the changing exercising HR. The mean correlation coefficient across participants and tests was 0.9886 (σ = 0.0002, SD = 0.017) and between the two systems at elevated HR was 0.9676 (σ = 0.002, SD = 0.05). Findings from Phase II found significant differences for the presence of artifacts and confidence in interpretation in ECGs between readers' for both intensities and testing conditions. Interpretation of ECGs for OW rowing had a lower level of reader agreement than ERG rowing for HR, rhythm, and artifact. Using consensus data between readers' significant differences were apparent between OW and ERG rowing at high-intensity rowing for HR (p = 0.05) and artifact (p = 0.01). ECGs were deemed of moderate-low quality based on confidence in interpretation and the presence of artifacts.ConclusionsThe PluxECG device records accurate and reliable HR but not ECG data during exercise in rowers. The quality of ECG tracing derived from the PluxECG device is moderate-low, therefore the confidence in ECG interpretation using the PluxECG device when recorded on open water is inadequate at this time.

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Dataset Information

An investigation into the diagnostic accuracy, reliability, acceptability and safety of a novel device for Continuous Ambulatory Vestibular Assessment (CAVA).

Publications

An investigation into the diagnostic accuracy, reliability, acceptability and safety of a novel device for Continuous Ambulatory Vestibular Assessment (CAVA).

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