FOUND

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 British Lung Foundation estimates that if all people with moderate to severe OSA are diagnosed and treated, the annual savings to the NHS in the UK will be £28 million.

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 therefore compare a new GP-based route using a device called AcuPebble with the current referral pathways for the diagnosis of OSA.

FOUND is a multi-centre 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. 

Patients who may be at higher risk of OSA (overweight, have hypertension, diabetes or both) will be invited by their clinician to take part in the trial, with a target total of 1,426 participants. They will be randomly split into two groups:

• The first (intervention) group will complete a home overnight sleep study using the AcuPebble. This device is comfortable and non-invasive, and is attached to the throat without the need of leads or wires.
• The second (control) group will continue as normal (referred to hospital via the traditional pathway if presenting a sleep study need).

Individuals diagnosed with OSA in either group will be referred for treatment through existing care pathways.

We will compare the number of new diagnoses of OSA in the two groups, looking at how well this new approach works compared to the current hospital-based referral route, and whether it is value for money for the NHS. If this strategy is successful in detecting OSA, it can be rolled out in primary care to improve the detection and treatment of OSA. Better detection would reduce risks, improve health and wellbeing; with fewer longer term health conditions.

Trial status: Recruiting

Trial duration: 

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.

The current list of GP practices participating in the FOUND study have been plotted on the map below:

• "New sleep apnoea diagnostic device could slash waiting times and improve quality of life" - Warwick University

• "New device trialled to speed up sleep apnoea diagnosis" - BBC

Prof Ly-Mee Yu, University of Oxford

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

Dr E Scott (Project Manager)

Dr R Harrison (CT Facilitator)

Ms E Buckingham (CT Facilitator)

Prof A Grove, University of Warwick

Dr S Prakash, University of Warwick

Mr C Rogers, Sleep Apnoea Trust

Ms O Dessi, Acurable

Mr E Sanz-Pereiras, Acurable

Prof E Rodriguez-Villegas, Imperial College London

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

REC: 23/SCO188

IRAS: 323422

BLF OSA Toolkit 2015

NICE Guidelines OSA 2021

A pilot study of a wearable apnoea detection device. BMJ Open 2014

Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open 2021