Clinical trial NCT05511285: Improving Sleep and Learning in Rehabilitation After Stroke, Part 2
Official title: Improving Sleep and Learning in Rehabilitation After Stroke, Part 2
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Sleep
Rehabilitation
Digital
Cognitive Behavioural Therapy for Insomnia
Motor consolidation
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Big Health Inc.
First posted: 2022-08-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sleep Condition Indicator
timeFrame: 10 weeks after randomisation
Secondary outcomes:
measure: Change in motor performance from training to retest
timeFrame: 10 weeks after randomisation
measure: Patient Health Questionnaire
timeFrame: 10 weeks after randomisation
measure: Fatigue Severity Scale
timeFrame: 10 weeks after randomisation
measure: Actigraphy
timeFrame: 10 weeks after randomisation
Other outcomes:
measure: Adherence of at home motor training
timeFrame: 14 weeks following randomisation
measure: Upper limb ability
timeFrame: 14 weeks following randomisation
measure: Upper limb function
timeFrame: 14 weeks following randomisation
measure: Upper limb dexterity
timeFrame: 14 weeks following randomisation
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
affiliation: University of Oxford
name: Melanie K Fleming, Dr
role: PRINCIPAL_INVESTIGATOR
References: