Clinical trial NCT06507228: North West London Pebble Pathway: Automated OSA Diagnosis
Official title: North West London Pebble Pathway: Automated OSA Diagnosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Sleep Apnea
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2024-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Propspective real world implementation and health economic study; historical control group for comparison
Primary purpose: DIAGNOSTIC

Brief summary: Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Current diagnostic approaches are expensive (£391), time-consuming (\>1-hour interpretation), uncomfortable (cables/tubes/wires), and inequitable (multiple hospital visits). Overcoming all these limitations, we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA. This will use the AcuPebble, a miniature wearable acoustic sensor and the first regulated technology for automated, at-home diagnosis. The test is cheap (\< £100); time-saving; endorsed by patients, and accessible (posted directly to patients). This project will measure the impact of a potentially transformative, innovative, and scalable diagnostic pathway using AcuPebble technology.

Detailed description: The investigators are conducting a prospective implementation and health economic study of a novel straight-to-test (STT) clinical diagnostic pathway for OSA, using a novel, regulatory-approved wearable medical device for automated diagnosis of OSA in the home setting (AcuPebble SA100). The setting is real-world direct clinical care, with participation from three NHS sleep medicine centres servicing the North West London region.

Inclusion criteria is primary care referrals for OSA investigation were triaged onto the pathway based on predetermined criteria, compared to a historical cohort of patients undergoing STT using cardiorespiratory polygraphy (CR-PG) technology serving as a control group. The primary outcome is time-to-diagnosis. Secondary outcomes include NHS cost-saving per patient; surrogates for health equity (e.g. test completion rates, time/cost of journeys saved); and carbon footprint reduction from averted patient journeys (sustainability).

Eligibility criteria: Inclusion Criteria:

* OSA testing referral from primary care

Exclusion Criteria:

* Unable to follow test instructions

Primary outcomes:
measure: Time to diagnosis
timeFrame: 12 months
Secondary outcomes:
measure: Cost saving per test
timeFrame: 12 months
measure: Test completion rate
timeFrame: 12 months
measure: Financial saving to patients from cutting journeys associated with appointments
timeFrame: 12 months
measure: Sustainability impacts by carbon footprint reduction
timeFrame: 12 months
measure: Time saving to patients from cutting journeys associated with appointments
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
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.