The cofounder and chief scientist at Big Health and professor of sleep medicine at the University of Oxford discussed the recent findings of a study of Sleepio in poststroke rehabilitation and the role that cognitive behavioral therapy could play in that care process.
Newly presented data from a study conducted at the University of Oxford suggests that Sleepio, a digital therapeutic for the treatment of insomnia, can improve sleep for patients who are undergoing rehabilitation after experiencing a stroke.1
Often, this patient population is faced with sleeping difficulties, with some literature showing roughly 50% of stroke survivors have insomnia, implying a need for improvement in sleep for poststroke recovery.2 The preliminary findings of the study of Sleepio showed that about 50% of those using the intervention reported a clinical improvement in sleep, while further analysis suggested that it also improved depression and anxiety at 8-weeks post initiation.1
Big Health, the developer of the therapeutic, noted in its announcement of the data—which were presented at the European Stroke Organisation (ESO) conference, May 4-6, in Lyon, France—that expanding access to include a poststroke population can aid sleep conditions and support recovery for patients. To find out more about the cognitive behavioral therapy (CBT) platform and the findings in this study, NeurologyLive® spoke with Colin Espie, PhD, cofounder and chief scientist, Big Health, and professor of sleep medicine, University of Oxford.
Colin Espie, PhD: Sleepio is a digital version of cognitive behavioral therapy. It's often called a digital therapeutic. And what it does is it delivers the guideline treatment for insomnia, and that guideline treatment is CBT. It delivers it through a fully automated software platform on web and mobile.
Basically, CBT is a guideline treatment for insomnia—the most common sleep problem—because what CBT does is addresses the two things that really are responsible for persistent sleep difficulties. One is the racing mind. We all know what it's like when we can't get to sleep when our mind is full and busy. And secondly, when we can't get our sleep into pattern, that's the behavioral element of it. CBT is a guideline treatment for insomnia associated with any condition—rather than medication. And, of course, in the case of people with who've had stroke, one would ideally prefer to use a nonpharmacological intervention in any case because these individuals have probably got a raft of medications and other treatments that they require.
What may surprise people about the study is that when people have had a major medical event, like a stroke, it's quite easy to think, “Oh, well, that's the primary thing, that's the thing we should really be worrying about. Everything else is kind of peripheral or secondary to that.” But the reality is that, that people are trying to get back to live their lives in their own homes, their own situations, struggling with the patterning of their sleep that may have changed because of the stroke and gotten worse. And, of course, anxiety is on their mind. This is why CBT for insomnia, including this population seemed totally appropriate.
I work as a professor of sleep medicine at the University of Oxford, and this was an inbound inquiry from colleagues in the university who work in stroke and stroke rehabilitation. They were recognizing that lots of people have difficulties with their sleep after stroke and wondering, could we do anything to improve that? Because, if possible, it seemed to be something that might make a difference. My approach that was say, “Well, we don't really know, do we? Theoretically, yes, but we need to do a study to actually evaluate whether this is of any meaningful benefit to individuals. Probably being the first study of its kind in this area, looking at looking at insomnia in stroke patients using CBT, we thought we would start with a relatively modest trial, but nonetheless, a clinical trial with the control group, to see if we get indications that that this was improving sleep.
We also thought we'd measure some other things as well, for example, mood, because there's a very strong connection between our ability to sleep and our mental health. So, we wanted to see that if we were able to do something to reduce insomnia symptoms, and whether that also had some associated effect on people's depressive symptoms. Although, they weren't depressed patients.
Well, we use the measure called the Sleep Condition Indicator, which is a standardized measure that that gives you an evaluation of insomnia against DSM5 criteria for insomnia disorder. And in brief, regardless of the disorder, if you've had difficulties initiating and or maintaining sleep—that is difficulties getting to sleep or getting back to sleep 3 or more nights per week for a minimum of 3 months—that's also having an impact on your ability to function. We didn't go through a full diagnostic schedule, in terms of clinical interviews in this study, we instead used this validated measure of DSM5, which is the Sleep Condition Indicator. What that measure does is it gives you a score, and if that score increases, that indicates your sleep is improving, and that your sleep is in better shape than it was before. It's a quite intuitive measure of the state that your sleep is in. It's a self-reported measure—which, of course, insomnia is a self-reported concern—and not only did we find improvements in insomnia symptoms associated with the intervention group relative the control group, but we also found the differences on that measure appear to be clinically meaningful. Not just statistical changes, but ones that appear to be clinically meaningful.
The other thing that we found here is that there were improvements, as I mentioned, on these other measures of mood. We use standardized measures there as well, the PHQ9 as a patient health questionnaire as a measure of depressive symptoms, and the GAD (or generalized anxiety disorders questionnaire) as a measure of anxiety symptoms. We found improvements in those as well in the treated group compared with the control.
The other thing that's important to say, of course, is that people found the intervention acceptable. You might wonder, what people's approach would be, considering the average age of 58 years or older, giving people a cognitive behavioral therapy intervention when they've had a stroke. Does this work? Can you do this kind of thing? Do these patients find approaching sleep in this kind of way as a treatment, acceptable? And I think the good news apart from the outcomes is that, generally speaking, the treatment was accessible for them. They did find it salient, and probably found it preferable to taking this practical approach, rather than being given prescription medications, which are mostly sedative and probably wouldn't be a good idea in stroke patients.
Well, to be honest, I always approach clinical trials with a healthy skepticism. I think it is better to approach science from the perspective of holding the null hypothesis in mind that there's probably nothing here, but if there is, we will find it. You design a study not to prove your point, but really to test it thoroughly.
There were adaptations that we had to make to some of the things that we would normally do because of people's say mobility problems or the ability to implement certain exercises. For example, if the program involves learning, relaxation methods, that's often done by learning how to tense and release your muscles in a systematic way or to learn to breathe a more diagrammatically. If people have got some degree of physical limitation or mobility problem, one sometimes has to adapt techniques. There was a limited amount of adaptation that we could do to the program, or that probably was even worth doing at the preliminary stage. Because we wanted to find out, is there a signal at all, does any of this work? I think there are learnings about how we could adapt things more and perhaps make them particularly salient to poststroke recovery, because there's nothing in the Sleepio program itself that even refers to stroke—it just refers to your insomnia. I think there are ways that we can address it.
We also want to follow up more on the people who didn't complete the program to find out as much as we can about what the obstacles or challenges might have been there for them. Where are they in terms of not finding it relevant to them, or finding it too difficult to implement? But the other thing that we find in this study, and that we find in other studies, as well, is that even if people only follow a program for part of the time, they're already learning skills, or new approaches to how to manage their sleep. Even if they haven't got the full dose of the whole program. For example, the mindset that CBT takes towards your sleep is somewhat paradoxical, if I can use that word, because your instinct when you can't do something is to try even harder to do better. To try to get to sleep, how do I get to sleep? When in fact, the CBT approach kind of teaches you that nobody gets to sleep, and no one is able to get to sleep, that you get to sleep by falling asleep and falling asleep is almost like an involuntary behavior. That's why good sleepers a sleep well, and they've no real knowledge of how they do that. So therefore, I think, from the perspective of someone who's been through a difficult time, who's trying to rehabilitate, is wanting to do all the right things, to learn—even in the early stage of a program—this is about relaxing into sleep, to let sleep happen, to get yourself back into a pattern, and to trust that it's going to come and to use some techniques to help deal with your intrusive thoughts. Those could be about your health, or they could be about “I'm never going to sleep tonight.” We find that these are kind of similar experiences that we all have when we can’t sleep, and they apply no less to someone even in those circumstances, but they may be all the more important because you need sleep for recovery purposes.
Transcript edited for clarity.