Clinical Evaluation of a Wearable Sleep Diagnosis Technology

Acurable

Status: Completed

Conditions: Obstructive Sleep Apnea

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03544086

225818 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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).

Trial design

150 participants in 2 patient groups

test group

Description:

First group is the first 10 patients

study group

Description:

following 150 patients