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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
100
6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.
University of Oxford
Oxford, United Kingdom
RECRUITINGSleep Condition Indicator
Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia
Time frame: 10 weeks after randomisation
Change in motor performance from training to retest
Behavioural motor consolidation assessment, assessed as accuracy (range 0-50, higher numbers indicate better accuracy of motor performance)
Time frame: 10 weeks after randomisation
Patient Health Questionnaire
Questionnaire assessing symptoms of depression, range 0-20, higher values indicate more depressive symptoms
Time frame: 10 weeks after randomisation
Fatigue Severity Scale
Questionnaire assessing fatigue, range 9-63, higher score indicates more severe fatigue
Time frame: 10 weeks after randomisation
Actigraphy
Wearable activity monitor used for assessing sleep disruption (Total Sleep Time, Wake After Sleep Onset, sleep fragmentation)
Time frame: 10 weeks after randomisation
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