North West London Pebble Pathway: Automated OSA Diagnosis (PEBBLE)

Patrik Bachtiger

Status: Enrolling

Conditions: Sleep Apnea; Obstructive Sleep Apnea

Treatments: Diagnostic Test: NWL PEBBLE STT

Study type: Interventional

Funder types: Other

Identifiers

NCT06507228

PA8366

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• OSA testing referral from primary care

Exclusion criteria

• Unable to follow test instructions

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

NWL PEBBLE STT patients

Other group

Description:

Real-world clinical care arm investigating novel pathway

Treatment:

Diagnostic Test: NWL PEBBLE STT