At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Digital Cognitive Behavioural Therapy for Insomnia (behavioural)
- How long the study runs
- Study runs about 63 months (dates as stated)
- About the drug or intervention
- Digital Cognitive Behavioural Therapy for Insomnia — behavioural: 6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 100
- Started
- 2022-09-13
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for stroke
- • NA - 100 participants
- • This study will explore whether sleep in stroke survivors is improved with digital cognitive behavioural therapy for insomnia (Sleepio), in comparison to treatment as usual, and will explore whether changes in sleep relate to changes in overnight consolidation of motor learning
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with stroke
Where?
- • Oxford - University of Oxford
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
This study will explore whether sleep in stroke survivors is improved with digital cognitive behavioural therapy for insomnia (Sleepio), in comparison to treatment as usual, and will explore whether changes in sleep relate to changes in overnight consolidation of motor learning.
More detail
Stroke is one of the leading causes of adult disability. Rehabilitation of movement after stroke depends on motor learning. Motor learning involves not only improvement during practice but also offline improvement, or consolidation, that occurs after practice. Consolidation of learning depends on good sleep quality. However, sleep is disrupted long-term after stroke and patients with poorer sleep show worse rehabilitation outcomes. Cognitive behavioural therapy for insomnia (CBT) is the recommended first line treatment for sleep problems. "Sleepio" is a digital CBT programme which is effective across a range of clinical populations. This study aims to test the efficacy of digital CBT for reducing insomnia symptoms after stroke, in comparison with usual care alone. To explore the possibility that sleep interventions might enhance rehabilitation outcomes via their impact on consolidation of motor learning, the study will additionally test for differences in consolidation between groups, and explore whether changes in sleep measures are associated with changes in consolidation. Participants will be randomised to either receive digital CBT for insomnia (in addition to usual care) or receive treatment as usual alone (2:1 treatment to control ratio). The primary outcome is the score on the 8-item Sleep Condition Indicator, 10 weeks following randomisation. Secondary outcomes include behavioural measures of overnight motor consolidation assessed as the change in motor task performance from training to retest, sleep disruption assessed with actigraphy, and depression and fatigue using the Patient Health Questionnaire (PHQ9) and the Fatigue Severity Scale respectively. In addition to this, to explore the feasibility of delivering rehabilitation following the sleep improvement programme, an optional 4 weeks of upper limb motor training at home will be offered to all participants (regardless of group allocation) after follow-up. Outcomes of adherence to the training and upper limb function will be assessed.
How this trial compares with your answers
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What we know so far
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- • Tell us your age for better matching
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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
What the study is looking for
- ✓Willing and able to give agreement to take part for participation in the study
- ✓Aged 18 years or above.
- ✓Clinical diagnosis of stroke affecting the upper limb, with sufficient movement to perform the motor learning task
- ✓Discharged from inpatient care
- ✓Interest in accessing a programme with the aim of improving sleep quality
Who cannot take part
- ✗Other neurological condition affecting movement (e.g. Parkinson's Disease, Multiple Sclerosis)
- ✗Diagnosed, untreated, sleep disorder (e.g. Sleep Apnea)
- ✗Uncontrolled seizures
- ✗Planned inpatient admission (e.g. for rehabilitation) in the next 4 months that would impact ability to engage with...
- ✗Engagement in psychological therapy for insomnia in the past 12 months
See the full criteria
Where Is This Study? (1 UK site)
University of Oxford
Oxford OX39DU, United Kingdom
How to Get in Touch
Melanie K Fleming, Dr
Sponsor contactCONTACT
Barbara Robinson
Sponsor contactCONTACT
