FOUND: Case Finding of Obstructive sleep apnoea in primary care Using a Novel Device
The trial is being led by the University of Warwick in collaboration with the University Hospitals Coventry & Warwickshire NHS Trust, the University of Oxford, the University of Birmingham and the Charity Hope2Sleep.
This trial is funded by the National Institute for Health and Care Research Invention for Innovation (NIHR i4i) programme.
ISRCTN registration date: 3rd July 2023
Registration number: ISRCTN16982033
Ethical approval: 9th June 2023
Background and Study Aims
Obstructive Sleep Apnoea (OSA) is a relatively common sleep disorder where the walls of the throat relax and narrow during sleep, interrupting normal breathing. This may lead to regularly interrupted sleep, which can have big impact on quality of life and if untreated, may lead to increased risk of developing certain diseases, such as obesity, diabetes, high blood pressure, heart attacks and strokes. The current practice of OSA screening varies across the UK with complex referral pathways to specialised clinics not available in all hospitals across the country.
The FOUND trial will compare a new GP-based route using a device called AcuPebble with the current referral pathways for the diagnosis of OSA.
Multi-centre, pragmatic, individually randomized, parallel group, superiority trial and economic evaluation to determine the effectiveness and cost-effectiveness of using a novel
MHRA-registered device (AcuPebble SA100) to detect Obstructive Sleep Apnoea in a high-risk group, compared to usual care.
A sample of approximately 40 GP practices will be recruited from within the West Midlands CRN to include different practice types according to list size, deprivation index, rural/urban location and practice type.
Prof Michelle A Miller, University of Warwick
Prof Franco P Cappuccio, University of Warwick
Dr A Ali, UHCW NHS
Dr P Apenteng, University of Birmingham
Dr P Auguste, University of Warwick
Prof J Dale, U of Warwick
Mrs K Hope, Hope2Sleep
Ms O Dessi, Acurable
Prof A Grove, University of Warwick
Dr S Prakash, University of Warwick
Prof E Rodriguez-Villegas, Imperial College London
Mr C Rogers, Sleep Apnoea Trust
Mr E Sanz-Pereiras, Acurable