1 Recommendations

People 16 years and over

Use as an option

1.1

Use the following home-testing devices as options to diagnose and assess the severity of obstructive sleep apnoea hypopnoea syndrome (OSAHS) in people 16 years and over:

  • AcuPebble SA100

  • Sunrise

  • WatchPAT 300

  • WatchPAT ONE.

1.2

When considering whether to use these devices in place of home respiratory polygraphy or home oximetry, take into account:

  • whether the device can provide the outputs that are needed for decisions about care, including whether a third-party oximeter can be used, particularly for identifying OSAHS in people with comorbidities

  • whether the person has hair in the area that the device attaches to that would need to be removed, and if this is acceptable for the person

  • whether the person has physical features such as skin conditions or scars that may affect how well the device attaches

  • the internet and smartphone access that would be needed to use the device

  • if attaching or using the device would be difficult for the person, and if they will have support with using the device.

1.3

These devices can only be used once they have appropriate regulatory approval including CE or UKCA marking, and NHS England's Digital Technology Assessment Criteria (DTAC) approval.

Can only be used in research

1.4

More research is needed on using the Brizzy home-testing device to diagnose and assess the severity of OSAHS in people 16 years and over before it can be used in the NHS.

People under 16 years

Can only be used in research

1.5

More research is needed on the following home-testing devices to diagnose and assess the severity of OSAHS in people under 16 years, before they can be used in the NHS:

  • Brizzy

  • Sunrise

  • WatchPAT 300

  • WatchPAT ONE.

What research is needed

1.6

More research is needed on:

  • how accurately the Brizzy device diagnoses and assesses the severity of OSAHS in people 16 years and over

  • how accurately Brizzy, Sunrise, WatchPAT 300 and WatchPAT ONE devices diagnose and assess the severity of OSAHS in people under 16 years

  • how accurately the home-testing devices diagnose and assess the severity of OSAHS in people with black or brown skin.

1.7

Access to the technologies for the populations and indications in sections 1.4 and 1.5 should be through company, research, or non-core NHS funding, and clinical and financial risks should be appropriately managed.

Why the committee made these recommendations

Home-testing devices for diagnosing OSAHS are designed to be more comfortable to wear and easier to use than home oximetry and home respiratory polygraphy systems. They may be more accurate at diagnosing OSAHS because they allow a more natural night's sleep. NHS sleep services are likely to still need some of the home oximetry or home respiratory polygraphy systems that are currently used to diagnose OSAHS. This is because the newer home-testing devices may not be suitable for some people if extra readings are needed that they do not provide.

The economic model suggests that the AcuPebble SA100, Sunrise, WatchPAT 300 and WatchPAT ONE devices are cost effective compared with home oximetry and home respiratory polygraphy in people 16 years and over. So, these devices can be used in this group. The estimates of diagnostic accuracy for the Brizzy device are uncertain, so the cost-effectiveness estimates are also uncertain. So, more research is needed.

There is very limited evidence for all the home-testing devices in people under 16 years and the evidence from adults is not generalisable to people under 16. So, more research is needed in this group.