StrokeINSPIRES-2NCT05511285
Improving Sleep and Learning in Rehabilitation After Stroke, Part 2
A study testing Digital Cognitive Behavioural Therapy for Insomnia in people with Stroke, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- Digital Cognitive Behavioural Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Sep 2022to Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Barbara Robinson contact
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, OX39DU
Barbara Robinson, sleep-win@ndcn.ox.ac.uk
Melanie Fleming, melanie.fleming@ndcn.ox.ac.uk
About this study
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- Digital Cognitive Behavioural Therapy for Insomnia
- Keywords
- Sleep, Rehabilitation, Digital, Cognitive Behavioural Therapy for Insomnia, Motor consolidation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Cognitive Behavioural Therapy for InsomniaBehavioural
Also called Sleepio
6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.
| Study group | Role | What they receive |
|---|---|---|
| Behavioural: Digital cognitive behavioural therapy for insomnia | Experimental | 6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. Receives: Behavioral: Digital Cognitive Behavioural Therapy for Insomnia |
| Treatment as usual | No intervention | Participants will receive treatment as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Condition Indicator
Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia
Measured: 10 weeks after randomisation
Secondary outcomes (4)
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)
Measured: 10 weeks after randomisation
Patient Health Questionnaire
Questionnaire assessing symptoms of depression, range 0-20, higher values indicate more depressive symptoms
Measured: 10 weeks after randomisation
Fatigue Severity Scale
Questionnaire assessing fatigue, range 9-63, higher score indicates more severe fatigue
Measured: 10 weeks after randomisation
Actigraphy
Wearable activity monitor used for assessing sleep disruption (Total Sleep Time, Wake After Sleep Onset, sleep fragmentation)
Measured: 10 weeks after randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start13 Sep 2022
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Big Health Inc.
- Responsible party
- Sponsor
- Investigators
- Melanie K Fleming, Dr, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05511285
- Sponsor's protocol ID
- PID 16015
- Acronym
- INSPIRES-2
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2022
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data are available upon reasonable request
Publications
Weightman M, Robinson B, Fallows R, Henry AL, Kyle SD, Garratt E, Pick A, Teal R, Ajina S, Demeyere N, Espie CA, Seymour B, Johansen-Berg H, Fleming MK. Improving sleep and learning in rehabilitation after stroke, part 2 (INSPIRES2): study protocol for a home-based randomised control trial of digital cognitive behavioural therapy (dCBT) for insomnia. BMJ Open. 2023 Apr 6;13(4):e071764. doi: 10.1136/bmjopen-2023-071764.
PubMed 37024247