NCT03544086

Clinical Evaluation of a Wearable Sleep Diagnosis Technology

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Acurable Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Obstructive Sleep Apnea

Timeline

• Start date: 2018-07-10
• Primary completion: 2019-12-30
• Completion: 2020-09-15
• First posted: 2018-06-01
• Last updated: 2020-12-04

Locations

1 site across 1 country: United Kingdom