Trial Protocol : A Randomised, Controlled Cross-Over Trial Evaluating the Digital Sleep Revolution Diagnostic-Therapeutic Pathway for Obstructive Sleep Apnoea

Abstract

Obstructive sleep apnoea (OSA) is common, but current diagnostic pathways rely on single-night assessment and the apnoea–hypopnoea index. Both are limited for assessment of variability and linking only weakly to symptoms, comorbidity and treatment response. The current protocol addresses this gap by aiming to validate a diagnostic pathway integrating a digital platform, mobile application, multiple-night sleep testing, semiautomated analysis and a novel sleep health questionnaire, labelled as ‘Sleep Revolution’. Study objectives are to compare staff time required for diagnosis between standard care and Sleep Revolution pathway, and to examine associations between multi-night sleep metrics and Positive Airway Pressure (PAP) treatment outcomes, diagnostic concordance, PAP prescription, patient satisfaction, adherence and feasibility. This multicentre, two-arm cross-over study is conducted at 23 sleep centres in Europe within the European Sleep Apnoea Database (ESADA) network. Adults referred for suspected OSA complete both standard care and the Sleep Revolution pathway in randomised order. Standard care includes single-night polygraphy or polysomnography according to local routines. The Sleep Revolution pathway comprises three nights of self-applied polysomnography (NOX-SAS), digital symptom assessment (mobile app) and the Withings ScanWatch (physical activity, physiological signals). Diagnosis and treatment decisions are based solely on the first pathway. Outcomes include staff time (primary), technical performance, diagnostic yield, patient-reported measures, PAP adherence and symptom change. The sample size is calculated as 1000 randomised participants. Ethical approval is obtained at all participating centres. The trial is registered with ISRCTN (ISRCTN17539031). Data acquisition is performed between Q1 2024 and Q2 2025; data cleaning and analyses are ongoing.