The technology

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).

The programme is structured around a series of 6 weekly interactive sessions, lasting about 20 minutes each. Users can access the programme for 12 months after their first login. They can also access electronic library articles, online tools and the online Sleepio user community.

A daily sleep diary helps users to track their progress, and the programme tailors advice to individuals. Users can fill in the diary manually, or the data may be automatically uploaded from a compatible wearable tracking device.

Sleepio has undergone a technical evaluation using the NHS Digital Assessment Questions, a pilot tool currently available to developers in beta form. The tool comprises 7 domains: clinical safety; security and privacy; confidentiality (information governance); usability and accessibility; technical stability; change management (updates and version control); and regulatory approval. NHS Digital has confirmed that Sleepio passed this assessment. The completed assessments are not currently published but are available on request.

Table 1 Technology components

Component (first UK launch, version number)

Regulatory status

Cost

Sleepio website

(February 2012, v6.80.0)

The developer has stated that Sleepio does not meet the current eligibility criteria for CE marking as a medical device or for regulation by the Care Quality Commission.

£200 for 12 months' access (individual purchases).

Discounts are offered for commissioners for multiple licences, or unlimited access within a population for a fee based on population size.

Sleepio app for iOS

(September 2014, v1.6.19)

As above.

Users who have created a Sleepio account online may also use the app at no extra cost.

Novel system benefit

  • Sleepio may improve access to CBT‑I, which is usually delivered over the course of 6 to 8 weekly face-to-face sessions with a trained therapist. This could potentially improve access to treatment if current demand exceeds local service capacity.

  • Sleepio can integrate data from wearable tracking devices, which is intended to allow faster and more accurate recording of a sleep diary than manual input.

Current care pathway

The NICE guidelines on depression in adults and depression in adults with a chronic physical health problem state that advice on good sleep hygiene should be offered if needed.

The NICE clinical knowledge summary on insomnia states that after good sleep hygiene advice, a short course of a hypnotic drug should be prescribed only if daytime impairment is severe. The treatment needs to be reviewed after 2 weeks and the person referred for CBT if symptoms persist.

NICE technology appraisal guidance on zaleplon, zolpidem and zopiclone for the short-term management of insomnia states that the choice of management strategy depends on the presenting symptoms. Non-pharmacological interventions such as CBT have been shown to be effective in managing persistent insomnia. However, in practice, access to many of these therapies is restricted through a combination of a lack of trained providers, cost and a poor understanding of available options.

Population, setting and intended user

Sleepio can be used by anyone aged over 16 years with poor sleep (that is, people who have difficulty falling or staying asleep, or who consistently wake up unrefreshed). It should not be used by pregnant women or children, because the sleep-restriction technique used in Sleepio is not suitable for people who need extra sleep. It may be used directly through self-referral, or through referral from a healthcare professional. It would be used in place of, or in addition to, a range of current interventions.

Equality considerations

NICE is committed to promoting equality, eliminating unlawful discrimination and fostering good relations between people with particular protected characteristics and others. In producing guidance and advice, NICE aims to comply fully with all legal obligations to: promote race and disability equality and equality of opportunity between men and women, eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, marriage and civil partnership, pregnancy and maternity (including women post-delivery), sexual orientation, and religion or belief (these are protected characteristics under the Equality Act 2010).

Sleepio can only be used by people who have regular and reliable access to the website. The Sleepio app is currently only available for iOS mobile devices.