Clinical Evaluation of a Wearable Sleep Diagnosis Technology

Completed

• Conditions: Obstructive Sleep Apnea

• Registration Number: NCT03544086
• Lead Sponsor: Acurable Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-05-22
• Study First Posted: 2018-06-01
• Study Start: 2018-07-10
• Primary Completion: 2019-12-30
• Study Completion: 2020-09-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea.

Exclusion Criteria

• Age under 18 or over 70 years.
• Subjects who are not fluent in English, or who have special communication needs.
• Known allergy to the adhesive dressing.
• Subjects with physical or mental impairments who would not be able to use the new technology on their own.
• Subjects with very loose/saggy skin in the neck area which would unavoidably result on - AcuPebble swinging if moving the neck.
• Subjects with pacemakers.
• exclude patients who have any type of implanted electronic devices (these include patients in ICDs and left ventricular assist devices and loop recorders).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivities and Specificities for diagnosis of sleep apnoea studies	6 months	Sensitivities and Specificities for diagnosis of sleep apnoea studies

Trial Locations

Locations (1)

Royal Free Hospital; 🇬🇧 London, United Kingdom