Sleep apnoea home testing device recommended for use in the NHS

The AcuPebble, developed by Imperial spinout Acurable, promises easier access to a diagnosis and savings for the health service.

A wearable medical device that tests for the breathing disorder obstructive sleep apnoea has been recommended for use in the NHS by the National Institute for Health and Care Excellence (NICE). Developed by Acurable, a company with its roots in research carried out at Imperial, the AcuPebble will help people get a diagnosis without spending a night in a sleep clinic. This will be better for patients and should save NHS resources.

While the device is already approved for use in the NHS, the new NICE guidance on the diagnosis of obstructive sleep apnoea (OSA) will result in many more patients being offered this as a standard.

“Medical technology like AcuPebble has the power to create a more efficient healthcare system that benefits both patients and clinicians, and it’s exciting to see bodies like NICE endorsing new patient care pathways centred around them,” said Professor Esther Rodriguez-Villegas, Acurable’s founder and chief executive.

Obstructive sleep apnoea is a condition in which a person’s breathing stops and starts while they are asleep, resulting in disturbed rest and loud snoring, often followed by headaches and severe fatigue the next day. On top of the impact on quality of life for sufferers and their partners, the condition can lead to life-threatening complications if left untreated, including heart attacks, type 2 diabetes, and dementia.

In 2019, a study concluded that around 10 million people in the UK suffer from obstructive sleep apnoea, but only 15% of cases are diagnosed. “Our hope is that more patients will be diagnosed using AcuPebble, freeing up clinician time to focus on treatment, and reducing the number of people who remain undiagnosed and at risk of more serious health complications,” said Professor Rodriguez-Villegas.

Avoiding the clinic

Deciding whether or not disturbed sleep is the result of sleep apnoea usually involves the patient spending a night in a sleep clinic, hooked up to a bank of monitors that track their breathing. On top of the discomfort involved, and the risk that this may confound the diagnosis by itself interrupting sleep, patients may have to travel long distances to attend these clinics and take time off work or caregiving responsibilities.

These respiratory polygraphs can be used at home, but the procedure is not simple and patients still need to visit the clinic to pick up and return the equipment. Either way, sleep professionals such as physiologists or consultants have to spend up to two hours interpreting each set of results to produce a diagnosis.

Acurable’s alternative is a fully automated remote test for sleep apnoea that is small enough to be posted to patients and simple enough that they can carry the tests out independently at home. The device is attached at the base of the neck to record the sounds generated by the patient’s respiratory and cardiac functions, amongst other physiological processes, a technique known as contact acoustics.

The signals are transferred wirelessly to a mobile device, and then uploaded to a secure cloud platform, where signal processing algorithms extract the parameters used to diagnose sleep apnoea. Healthcare professionals get an automatically generated diagnosis report within minutes.

Wearable technologies

The AcuPebble has its roots in more than a decade of research at the Wearable Technologies Lab that Professor Rodriguez-Villegas directs in the Department of Electrical and Electronic Engineering. She founded Acurable 2016 to apply this research to the diagnosis of respiratory and cardiovascular diseases.

The current generation of devices was designed from scratch by the company, and the AcuPebble for sleep apnoea is its first application to reach the clinic. It secured a European CE quality mark in 2020 and in 2021 it was approved for use in the USA by the US Food and Drug Administration. In 2022 Acurable completed a €11 million (£9 million) Series A investment round to support the further growth and internationalisation of the company.

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The  NICE recommendation, which covers both the effectiveness and the cost of the device, means that the AcuPebble will now become one of the standard methods for diagnosing sleep apnoea in the National Health Service in England. This advice will also be considered in Wales, Scotland and Northern Ireland.

Alongside the AcuPebble for sleep apnoea, the company has also developed a version of the device that can be used to measure breathing and cardiac signals in research studies and clinical trials. This comes with algorithms that analyse signals for conditions such as chronic obstructive pulmonary disease, asthma and coronavirus infections.