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  • Question on Consultation

    Has all of the relevant evidence been taken into account?
  • Question on Consultation

    • Are the summaries of clinical and and cost effectiveness reasonable interpretations of the evidence?
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    Are the recommendations sound and a suitable basis for guidance to the NHS?
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    • Are there any equality issues that need special consideration and are not covered in the medical technology consultation document?
The content on this page is not current guidance and is only for the purposes of the consultation process.

2 The technology

Technology

2.1 Sleepio (Big Health) is a self-help sleep improvement programme based on cognitive behavioural therapy for insomnia (CBT‑I). It is accessed through a website or an app for iOS mobile devices and can link to a compatible wearable fitness tracker to monitor sleep (currently Fitbit and any other device that uses Apple's HealthKit).

2.2 The programme is structured around a sleep test, weekly interactive CBT‑I sessions and regular sleep diary entries. The sessions focus on identifying thoughts, feelings and behaviours that contribute to the symptoms of insomnia. Cognitive interventions aim to improve the way a person thinks about sleep and behavioural interventions aim to promote a healthy sleep routine. Although the programme can be completed in 6 weeks, people can use the programme for 12 months from registration. They can also access electronic library articles, online tools and the online Sleepio user community. A daily sleep diary helps users track their progress and the programme tailors advice to individuals. Users can fill in the diary manually or the data can be automatically uploaded from a compatible wearable tracking device.

2.3 People can get Sleepio via self referral on the product website or through referral by a healthcare professional in regions of the NHS where it is commissioned. For patients with mental health conditions managed in routine care, use of Sleepio may benefit from the involvement of a healthcare professional.

Care pathway

2.4 The British Association of Psychopharmacology (BAP) consensus statement on insomnia describes treatment options for adults with poor sleep, which depend on how long they have had insomnia for. People are first offered advice about sleep hygiene. If this does not work and they are severely impaired during the day, and it is causing significant distress, they can be offered a 3 to 7 day course of a non-benzodiazepine hypnotic medication. Hypnotic medication should only be considered if symptoms are likely to resolve soon (for example because of a short-term stressor). If not, they should be offered face-to-face or digital CBT‑I. Currently, face-to-face CBT‑I is not routinely available in the NHS for most people with insomnia. A short-term course of hypnotic medication can be offered in addition to CBT‑I but should not be offered routinely. People should be offered follow-up consultations every 2 to 4 weeks to review their symptoms.

2.5 NICE's clinical knowledge summary on insomnia summarises the latest evidence on managing insomnia in primary care, based on whether it is short term (less than 3 months) or long term (more than 3 months). For both the advice is to consider referral to a sleep clinic or neurology if the person has symptoms of another sleep disorder, and to address whatever might be causing the insomnia. It also advises making sure comorbidities such as anxiety and depression are managed. It gives the same advice on sleep hygiene, hypnotic medication and CBT‑I as BAP.

2.6 People with insomnia often also have a mental health problem. NICE's clinical guideline on common mental health problems recommends assessing people using the improving access to psychological therapies (IAPT) screening tools and validated scales. Treatment depends on symptom severity and includes education, monitoring, CBT and medication.

Innovative aspects

2.7 Sleepio uses an artificial intelligence (AI) algorithm to provide people with tailored digital CBT‑I. There is also support available from a Sleepio community, which includes clinical experts and other people with insomnia.

Intended use

2.8 Sleepio is primarily intended as an alternative to usual treatment, which includes sleep hygiene education and hypnotic medication. People can get Sleepio through self referral, or through primary care or IAPT services.

Training

2.9 The company offers primary care training on prescribing Sleepio, technical training and set up.

Costs

2.10 The cost of Sleepio depends on the number of adults in a region's healthcare system. It is £0.90 per person for regions with more than 1 million people. Cost increases for smaller regions, up to £1.00 per person for regions with 250,000 people or fewer. During the evaluation the company proposed a different cost model, see section 3.13 for further details.

For more details, see the website for Sleepio.