Improving Sleep and Learning in Rehabilitation After Stroke, Part 2
ConditionStroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oxford
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Digital Cognitive Behavioural Therapy for Insomnia
Behavioral6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Behavioural: Digital cognitive behavioural therapy for insomniaExperimental treatment 1 intervention
Group B: Treatment as usualNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Sleep Condition Indicator
Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia
Time frame
10 weeks after randomisationSecondary outcomes
1
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 randomisation2
Patient Health Questionnaire
Questionnaire assessing symptoms of depression, range 0-20, higher values indicate more depressive symptoms
Time frame
10 weeks after randomisation3
Fatigue Severity Scale
Questionnaire assessing fatigue, range 9-63, higher score indicates more severe fatigue
Time frame
10 weeks after randomisation4
Actigraphy
Wearable activity monitor used for assessing sleep disruption (Total Sleep Time, Wake After Sleep Onset, sleep fragmentation)
Time frame
10 weeks after randomisationOther outcomes
1
Adherence of at home motor training
Assessment of number of sessions performed, number of repetitions etc.
Time frame
14 weeks following randomisation2
Upper limb ability
Assessed with Action Research Arm Test, range 0-57, higher score indicates better upper limb ability
Time frame
14 weeks following randomisation3
Upper limb function
Assessed with Box and Blocks Test, scored as the number of blocks transferred in 60 seconds
Time frame
14 weeks following randomisation4
Upper limb dexterity
Assessed with Nine hole peg test, scored as the number of pegs placed in 30 seconds
Time frame
14 weeks following randomisationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Oxford
Lead sponsor
Big Health Inc.
Collaborator
Source ClinicalTrials.gov