Abstract / Summary
Background Obstructive sleep apnoea (OSA) is common in children and associated with significant childhood morbidity. The current reference standards for paediatric OSA diagnosis are attended polysomnography (PSG) and cardio-respiratory polygraphy (CR-PG) - both resource-intensive and access-limited. No fully-automated diagnostic device has previously been prospectively validated against PSG or CR-PG. Methods Prospective, blinded, multicentre diagnostic-accuracy study at two UK tertiary paediatric centres. Consecutive children referred for suspected OSA were studied overnight by attended in-hospital paediatric sleep study (reference standard PSG or CR-PG, scored per AASM paediatric rules) and by AcuPebble SA100, a wearable sensor producing an automated diagnosis, set up by carers who also completed a usability questionnaire. Results 141 children had valid data (median age 7.1 years, range 1.2–17.3 years; 88.7% with comorbidities; 36.2% with learning difficulties). For moderate-or-severe OSA (OAHI ≥5·h −1 ), AcuPebble achieved sensitivity 100% (95%-CI 80.49–100), specificity 96.77%, accuracy 97.16%, positive predictive value 80.95%, negative predictive value 100%, and positive likelihood ratio 31.0. Performance was similar on the broader AHI (additionally capturing central events): sensitivity 94.12%, specificity 98.13%, positive likelihood ratio 50.4. Among surveyed carers, 97.0% completed setup unassisted; 81.9% rated AcuPebble as more comfortable than conventional sensors; only 10.5% would prefer PSG/CR-PG. Conclusions Automated diagnosis of paediatric OSA with AcuPebble met recommended diagnostic-accuracy thresholds. Carer-led setup was feasible and acceptable, supporting the device's use as an alternative to attended in-hospital sleep studies. Performance was maintained in a complex tertiary-referral cohort, where sleep studies are most difficult to deliver.