RecruitingNAINTERVENTIONAL

Improving Sleep and Learning in Rehabilitation After Stroke, Part 2

After a stroke, many people struggle with sleep, which can make it harder to relearn movements in rehabilitation. This study is investigating if a digital app called Sleepio, which offers a type of talking therapy for sleep problems, can help stroke survivors sleep better. We're comparing Sleepio plus their usual care, to just usual care alone. We also want to understand if improving sleep can lead to better learning and memory for movements, which often happens overnight. We hope this could improve rehabilitation outcomes for stroke patients.

At a glance

Status

Recruiting

Phase

Sponsor

University of Oxford

Enrolment target

100

Start

13 Sep 2022

Estimated completion

01 Jun 2026

Stroke

What is this study about?

Having a stroke can impact many areas of a person's life, and one common challenge is sleep. Many stroke survivors find their sleep is disturbed, and that can make it harder to get the most out of their physical rehabilitation. When you learn new movements, your brain often needs good sleep to properly 'store' or consolidate that learning, especially overnight.

This study is looking into whether a digital programme called 'Sleepio' can help solve these sleep problems. Sleepio offers a type of therapy called Cognitive Behavioural Therapy for Insomnia (CBT-I), which is a proven way to help people with sleep difficulties. We want to see if using Sleepio, alongside the usual care people receive after a stroke, can improve their sleep. We'll compare this to a group of people who just receive their usual care.

Beyond simply improving sleep, we're also really interested in whether better sleep can lead to better recovery of movement. If sleep improves, does it help people remember and improve their newly learned movements more effectively overnight? This information could be very important for planning future rehabilitation programmes.

Key takeaways

The study explores a digital programme (Sleepio) for sleep problems after a stroke.
It aims to see if better sleep helps stroke survivors learn movements effectively.
Participation involves questionnaires and tasks, lasting 10 weeks.
You might get access to the Sleepio programme or continue with usual care.
There's an optional 4-week exercise programme after the main study.

Who may be eligible?

To join this study, you need to be an adult (18 or over) who has had a stroke that affects your arm or hand, but you should still have some movement in it. You must have already left hospital after your stroke.

You should also be interested in trying a programme to improve your sleep and have reliable access to the internet. You won't be able to join if you have other conditions affecting movement like Parkinson's, or an untreated sleep disorder like sleep apnea. If you've had talking therapy for sleep problems recently or are pregnant, you also can't take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you had a stroke affecting your arm or hand, and can you still move it a bit?
Are you interested in improving your sleep?
Do you have reliable internet access at home?
Are you NOT pregnant and haven't had other sleep therapy recently?
Do you NOT have other serious movement conditions or untreated sleep problems?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be placed into one of two groups by chance: either you'll get access to the Sleepio digital programme in addition to your usual care, or you'll continue with your usual care alone. There will be twice as many people in the Sleepio group as the usual care group.

Over 10 weeks, we'll keep track of your sleep using questionnaires. We'll also ask you to do some tasks to check your movement and learning, and you might wear a small device to measure your sleep patterns. You'll also complete questionnaires about your mood and tiredness. After this initial 10-week period, everyone will be offered an optional 4-week programme of home exercises for their arm or hand. This is to see how easy it is to add rehabilitation after improving sleep, and you can decide if you want to do it or not. The total duration of the sleep part of the study is 10 weeks, with an optional 4-week exercise programme afterwards.

Potential risks and benefits

Participating in this study might offer you the benefit of better sleep if you are in the Sleepio group, which could also potentially help your movement recovery. However, there's no guarantee that you will personally benefit. For people in the usual care group, there's no direct benefit other than contributing to research. The risks are generally low, mainly involving the time commitment for questionnaires and tasks. All your information will be kept private. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of Oxford
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is 'Sleepio'?

Sleepio is an online programme that uses cognitive behavioural therapy (CBT) techniques to help people improve their sleep without medication.

Will I have to take any new medicines?

No, this study does not involve taking any new medications. The intervention is a digital programme.

Who is funding this research?

The information provided doesn't state the specific funding body, but it's a research study looking at stroke recovery.

What happens if my sleep doesn't improve?

Even if your sleep doesn't improve, your participation is valuable and helps us understand more about sleep after stroke.

How much time will this take up?

The main part of the study lasts 10 weeks with questionnaires and tasks; there's an optional 4-week exercise programme afterwards.

How to find out more

Melanie K Fleming, Dr

melanie.fleming@ndcn.ox.ac.uk 01865 611 461 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.