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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep and Learning in Rehabilitation After Stroke, Part 2
- ClinicalTrials.gov ID
- NCT05511285
- Acronym / sponsor ID
- INSPIRES-2 / PID 16015
- Conditions
- Stroke
- Keywords
- Sleep, Rehabilitation, Digital, Cognitive Behavioural Therapy for Insomnia, Motor consolidation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Big Health Inc.
- Study start
- 13 Sep 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 22 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Behavioural: Digital cognitive behavioural therapy for insomnia | Experimental | Behavioral: Digital Cognitive Behavioural Therapy for Insomnia6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online. |
| Treatment as usual | No intervention | –Participants will receive treatment as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Cognitive Behavioural Therapy for InsomniaAlso: Sleepio6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care. | Behavioural | Behavioural: Digital cognitive behavioural therapy for insomnia |
Primary outcome
Sleep Condition Indicator
Time frame: 10 weeks after randomisation
Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia
4 secondary outcomes
Change in motor performance from training to retest
Time frame: 10 weeks after randomisation
Patient Health Questionnaire
Time frame: 10 weeks after randomisation
Fatigue Severity Scale
Time frame: 10 weeks after randomisation
Actigraphy
Time frame: 10 weeks after randomisation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Derived from this study: PubMed 37024247Weightman 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.
- Individual participant dataSharing planned: Yes. De-identified data are available upon reasonable request
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Role of EEG in Differentiation Between Ischemic and Hemorrhagic Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barbara Robinson contact
Melanie K Fleming, Dr principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Cognitive Behavioural Therapy for Insomnia in people with Stroke, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melanie K Fleming, Dr (01865 611 461, melanie.fleming@ndcn.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Condition Indicator (time frame: 10 weeks after randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05511285, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.