Journal Article Ahead of print
PubMed: 42773566 DOI: 10.1111/jsr.70457
Trial Protocol: A Randomised, Controlled Cross-Over Trial Evaluating the Digital Sleep Revolution Diagnostic-Therapeutic Pathway for Obstructive Sleep Apnoea.
J Sleep Res
Authors: Ludger Grote, Erna Sif Arnardottir, Özen K Basoglu, Maria R Bonsignore, Zoran Dogas, Marta Drummond, Francesco Fanfulla, Haralampos Gouveris, Carolina Lombardi, Stefan Mihaicuta, Athanasia Pataka, Thomas Penzel, Winfried Randerath, Silke Ryan, Tarja Saaresranta, Sophia Schiza, Pawel Sliwinski, Richard Staats, Dries Testelmans, Paschalis Steiropoulos, Georgia Trakada, Johan Verbraecken, Sebastien Bailly, Anna Sigridur Islind, Timo Leppänen, Dirk Pevernagie, Ding Zou, Dimitri Ferretti, Jan Hedner
Affiliations
- Centre for Sleep Research, Institute of Medicine, Sahlgrenska Academy, Gothenburg University and Sahlgrenska University Hospital, Gothenburg, Sweden.
- Sleep Institute, School of Technology, Reykjavik University, Reykjavík, Iceland.
- Department of Respiratory Medicine, Ege University School of Medicine, İzmir, Türkiye.
- PROMISE Department, University of Palermo, Palermo, Italy.
- Sleep Medicine Center, Department of Neuroscience, University of Split School of Medicine, Split, Croatia.
- Respiratory Department and Sleep and Ventilation Unit, Centro Hospitalare Universitário de São João, Porto, Portugal.
- Respiratory Function and Sleep Unit, Istituti Clinici Scientifici Maugeri IRCC, Istituto di Pavia e Montescano, Pavia, Italy.
- Sleep Medicine and Neurostimulation Center, Department of Otorhinolaryngology, University Medical Center Mainz, Mainz, Germany.
- University of Milano Bicocca, Milan, Italy.
- Centre for Research and Innovation in Precision Medicine of Respiratory Diseases, Department of Pulmonology, "Victor Babes" University of Medicine and Pharmacy, Timișoara, Romania.
- Respiratory Failure Unit, G. Papanikolaou Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.
- Schlafmedizinisches Zentrum, Charité - Universitätsmedizin Berlin, Berlin, Germany.
- Bethanien Hospital, Clinic of Pneumology and Allergology, Center for Sleep Medicine and Respiratory Care, Institute of Pneumology at the University of Cologne, Solingen, Germany.
- School of Medicine, University College Dublin, Dublin, Ireland.
- Pulmonary and Sleep Disorders Unit, St. Vincent's University Hospital, Dublin, Ireland.
- Sleep Research Centre, Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Turku, Finland.
- Department of Pulmonary Diseases, Turku University Hospital, Turku, Finland.
- Sleep Disorders Center, Department of Respiratory Medicine, School of Medicine, University of Crete, Heraklion, Greece.
- 2nd Department of Respiratory Medicine, Institute of Tuberculosis and Lung Diseases, Warsaw, Poland.
- Department of Respiratory Medicine, Hospital de Santa Maria, Lisbon, Portugal.
- Sleep Disorders Centre, University Hospital Gasthuisberg, Leuven, Belgium.
- Department of Pneumonology, Democritus University of Thrace, Alexandroupolis, Greece.
- Pulmonary Medicine, National and Kapodistrian University of Athens, Athens, Greece.
- Multidisciplinary Sleep Disorders Centre, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium.
- HP2 Laboratory, INSERM U1300, Grenoble Alpes University and EFCR Laboratory, Thorax and Vessels Division, Grenoble Alpes University Hospital, Grenoble, France.
- Department of Computer Science, Reykjavik University, Reykjavík, Iceland.
- Department of Technical Physics, University of Eastern Finland, Kuopio, Finland.
- Clinical Research Centre, Kuopio University Hospital, Kuopio, Finland.
- School of Electrical Engineering and Computer Science, The Queensland University, Brisbane, Australia.
- Department of Internal Medicine and Paediatrics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.
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.
MeSH
Clinical Protocols, Patient Participation, Sleep, Polysomnography, Multiple Chronic Conditions, Mobile Applications, Therapeutics, Digital Diagnosis