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    The content on this page is not current guidance and is only for the purposes of the consultation process.

    DIAGNOSTICS ASSESSMENT PROGRAMME

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    1 Recommendations

    Only devices with appropriate regulatory approval will be included in the final guidance.

    People 16 years and over

    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

    • Brizzy

    • NightOwl

    • WatchPAT 300

    • WatchPAT ONE.

    1.2

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

    • the device outputs that are needed for decisions about care and whether the device can provide these, particularly for people with comorbidities (see section 3.8)

    • 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 (see section 3.11)

    • whether the person has physical features such as skin growths or scars that may affect how well the device attaches (see section 3.11)

    • the internet and smartphone access that would be needed to use the device (see section 3.12)

    • if attaching or using the device would be difficult for the person, and if they have support at home (see section 3.1).

    1.3

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

    1.4

    More research is needed on using Sunrise 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

    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:

    • AcuPebble SA100

    • Brizzy

    • NightOwl

    • Sunrise

    • WatchPAT 300

    • WatchPAT ONE.

    More research

    1.6

    More research is needed on:

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

    • how accurately AcuPebble SA100, Brizzy, NightOwl, Sunrise, WatchPAT 300 and WatchPAT ONE 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 less invasive, more comfortable to wear and easier to use than home oximetry and home RP systems. Minimal or no help is needed from healthcare professionals to use and attach the devices. They may also be more accurate at diagnosing OSAHS because they allow a more natural night's sleep. OSAHS is currently diagnosed using home oximetry and home RP systems. These have multiple wires and home RP systems use a cannula inserted into the nose. They may be uncomfortable to wear, and the person often needs a hospital appointment to be shown how to use them. Services will still need some home oximetry or home RP systems because home-testing devices may not be suitable for some people because of the person's comorbidities or the outputs the devices deliver.

    The economic model uses data on how accurately the home-testing devices detect OSAHS and assess its severity, compared with home RP and home oximetry. The model suggests that AcuPebble SA100, Brizzy, NightOwl, WatchPAT 300 and WatchPAT ONE are cost effective compared with home oximetry and home RP. So, these devices can be used.

    The estimates of diagnostic accuracy for Sunrise are uncertain, so the cost-effectiveness estimates are also uncertain. This is because the design of the available studies may have produced results that overestimate diagnostic accuracy. 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. This is mainly because the underlying causes of OSAHS in people under 16 are different to adults. So, more research is needed in this group.