Improving Sleep and Learning in Rehabilitation After Stroke, Part 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2026-06-30

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.

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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.

Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Randomisation and facilitation of the intervention will be performed by a research assistant, and the person analysing the data will be blinded to group allocations.

Study Groups

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Behavioural: Digital cognitive behavioural therapy for insomnia

6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.

Group Type EXPERIMENTAL

Digital Cognitive Behavioural Therapy for Insomnia

Intervention Type BEHAVIORAL

6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.

Treatment as usual

Participants will receive treatment as usual.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digital Cognitive Behavioural Therapy for Insomnia

6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.

Intervention Type BEHAVIORAL

Other Intervention Names

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Sleepio

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No