Clinical Evaluation of a Wearable Sleep Diagnosis Technology

Status Completed

Clinical Trial Summary

The primary endpoint is to evaluate the sensitivities and specificities for diagnosis of sleep apnoea of a wearable sleep diagnosis technology vs. existing gold standard.

Clinical Trial Description

The clinical investigation will be performed at the Royal Free London Hospital. Physiological signals will be pseudo-anonymized and only viewed by the research team. The Study will involve patients who will have been referred for diagnosis of sleep apnoea, will aim to determine AcuPebble's positive and negative predictive ratios, sensitivities as specificities. Likelihood ratios for diagnosis of sleep apnoea. Clinical experts will determine patients' diagnostic information using the current diagnostic standards. AcuPebble will also generate diagnostic results independently and automatically. Both set of results will be subsequently compared and the relevant performance metrics listed above will be determined. Consecutive patients referred for sleep study will be recruited to the study. Patients that are willing to participate will be consented on the day of their sleep study and sent home with both - the Trusts usual multichannel polygraphy and the Acupebble. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03544086
Study type	Observational
Source	Acurable Ltd.
Contact
Status	Completed
Phase
Start date	July 10, 2018
Completion date	September 15, 2020

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