How an app can improve your sleep (in a scientifically proven way) 

Insomnia: an overlooked disorder

Insomnia is the most common sleep disorder, affecting about 1 adult in 4, although prevalence estimates may vary according to the definition used.

A simplistic definition based on DSM-5 criteria for insomnia could be:

Difficulty initiating or maintaining sleep or early-morning awakening that leads to dissatisfaction with sleep quantity or quality, which occurs at least 3 nights per week, for at least 3 months, causing significant distress or impairment¹.

Insomnia is often overlooked and untreated, but its consequences could be significant (e.g. increased risk of depression, impaired work performance, motor vehicle accidents, and overall poor quality of life)².

How to treat insomnia?

To address this unpleasant sleep disorder, many people try supplements (such as melatonin or valerian) or, more useful, lifestyle remedies (like trying to stick to a sleep schedule, limit daytime naps, avoid large meals before bedtime, stay active but avoid physical exercise before bedtime).
However, even if tried remedies hadn’t worked, don’t despair because insomnia is treatable and a visit to your doctor may be well worth. Your general practitioner may recommend cognitive behavioural therapy, medications or both, to help improve relaxation and sleep.

A digital science-backed therapy

What is especially relevant for this website is that cognitive behavioural therapy for insomnia is no longer just a traditional treatment option, but is currently provided also through mobile apps or websites.
And we’re not talking about commercial grade apps with no clinical evidences, but medical apps which well worth to be called digital therapeutics.

Sleepio and the UK National Health Service

A promising story about treating sleeplessness regards the UK NHS and Sleepio, a self-help digital programme based on CBT, which help resetting sleeping patterns naturally, without relying on sleeping pills.
Indeed, on October 2018 the NHS started offering free direct access to Sleepio to individuals working or living within Greater London, Buckinghamshire, Berkshire and Oxfordshire.

Sleepio starts with a questionnaire about sleep and related topics, your perceptions and goals and then a virtual coach will guide you along a customised 6-week sleep therapy program.
During this journey, you’ll learn new tools/habits through the 6 weekly sessions and then you’ll track improvements filling in the sleep diary. Each session lasts about 20 min and is tailored to user’s progress and goals.

The science behind Sleepio

In clinical trials, Sleepio was able to help over three-quarters of insomnia sufferers achieve normal sleep and has been positively evaluated by NICE, the UK National Institute for Health and Care Excellence^{3, 4}.

Of note, Sleepio conducted the first placebo-controlled trial for a digital sleep improvement program. Indeed, this digital therapeutic solution was compared not only vs treatment as usual but also vs a credible digital placebo, delivered using the same application platform, design and execution principles as for CBT, but with no known active therapeutic ingredient³.

This trial demonstrated for Sleepio an higher improvement on the primary endpoint of sleep efficiency (the percentage of time asleep on the total time spent in bed), both at the end of the program and at follow-up 8 weeks post-treatment (see figure)³.

Improving access to care (at a reduced cost)

Sleepio may improve access to CBT for insomnia, which is usually delivered over the course of 6 to 8 weekly face-to-face sessions with a trained therapist. This digital treatment could potentially improve access to treatment if current demand exceeds local service capacity[4] or if someone is too lazy or ashamed to find a therapist.

Just in 2017, over 12 million prescriptions for insomnia were written in UK, at a cost to the NHS of £72 million. Through this agreement with Big Health (the creators of Sleepio), the NHS hopes to improve sleep quality and quantity of their citizens while saving money.

Indeed, Sleepio could be cost saving if it were shown to be as effective as face-to-face CBT for insomnia (£200 of Sleepio individual licence compared with an average of £582 for face-to-face therapy; and we may bet NHS obtained a consistent additional discount). Additionally, cost savings may also result from reduced hypnotic drug prescribing treatment⁴.

Beyond Sleepio

Other digital tools/apps

There are a lot of apps currently available on app stores claiming to help sleeping better, often with weak or not-al-all supporting evidences, but also other well-known DTx companies are working hard to developed scientifically validated digital treatments for insomnia. For example, Pear Therapeutics (famous in the DTx world for its apps to treat substance abuse disorders) is developing PEAR-003, a insomnia/depression DTx candidate. And also Click Therapeutics reached final stages of clinical development, conducting an efficacy clinical study for its insomnia digital therapy, Clickadian (CT-141).

Wearables

Going beyond apps and online interventions classifiable as DTx, also wearables may come to our aid. Smartwatch or other wearables with sleep tracking capabilities are indeed increasingly common.

These wearables, in addition to promote an active lifestyle (on their own or with their companion apps), could be integrated with the above-mentioned scientific-backed apps, in order to allow faster and more accurate recording of a sleep diary than manual input.

Another potentially extremely useful feature offered by some wearables is “smart alarm”. This intelligent alarm wakes you up during light sleep, or at least claims to do so… I added this last consideration on the basis of my personal experience. Indeed, my smartwatch is great monitoring steps, heart rate, encouraging not staying sit too long, but fails while trying to wake me up smartly. The first week I always worn it, however it never waked me up before the ‘last available’ alarm time (even if I was previously in light sleep according to its own data).

Looking forward

Despite the good idea behind them, indeed, we must remind ourselves the differences between commercial-grade apps and wearables rather than proper DTx or medical devices. Until scientifically proven, we must not put much faith in them, however we’re in the right direction: wearables certified as medical devices are coming such us presumably other sleep-aiding DTx.