Improving Sleep and Learning in Rehabilitation After Stroke, Part 2

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Improving Sleep and Learning in Rehabilitation After Stroke, Part 2

Conditions
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Stroke

Intervention / Treatment
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* Behavioral: Digital Cognitive Behavioural Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to give informed consent 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 Reliable access to the internet Exclusion Criteria: 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 the Sleepio programme Engagement in psychological therapy for insomnia in the past 12 months Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomised controlled trial with two parallel study arms: (1) digital cognitive behavioural therapy for insomnia (experimental condition), and (2) treatment as usual (control condition). Randomisation will be using a 2:1 ratio (experimental:control), within minimisation of between group differences in age, sex, baseline Sleep Condition Indicator score and time since stroke.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioural: Digital cognitive behavioural therapy for insomnia<br>6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. | Behavioral: Digital Cognitive Behavioural Therapy for Insomnia<br>* 6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.<br>* Other names: Sleepio;|
| No Intervention: Treatment as usual<br>Participants will receive treatment as usual. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Condition Indicator | Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia | 10 weeks after randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 10 weeks after randomisation | 
| Patient Health Questionnaire | Questionnaire assessing symptoms of depression, range 0-20, higher values indicate more depressive symptoms | 10 weeks after randomisation | 
| Fatigue Severity Scale | Questionnaire assessing fatigue, range 9-63, higher score indicates more severe fatigue | 10 weeks after randomisation | 
| Actigraphy | Wearable activity monitor used for assessing sleep disruption (Total Sleep Time, Wake After Sleep Onset, sleep fragmentation) | 10 weeks after randomisation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep, Rehabilitation, Digital, Cognitive Behavioural Therapy for Insomnia, Motor consolidation