Clinical trial NCT03544086: Clinical Evaluation of a Wearable Sleep Diagnosis Technology
Official title: Clinical Evaluation of a Wearable Sleep Diagnosis Technology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Lead sponsor: Acurable Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Royal Free Hospital NHS Foundation Trust
First posted: 2018-06-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been referred to a sleep clinic due to suspicion of sleep apnoea, consecutive 160 patients coming to the clinic.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Sensitivities and Specificities for diagnosis of sleep apnoea studies
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Free NHS Hospital
name: Dr Swapna Mandal, BSc MBBS MRCP SCE, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Devani N, Pramono RXA, Imtiaz SA, Bowyer S, Rodriguez-Villegas E, Mandal S. Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open. 2021 Dec 21;11(12):e046803. doi: 10.1136/bmjopen-2020-046803.