StrokeINSPIRESNCT04272892
Improving Sleep in Rehabilitation After Stroke
A study testing Digital cognitive behavioural therapy for insomnia and Sleep hygiene information in people with Stroke, run by University of Oxford at 1 site in United Kingdom.
Trial summary
This study evaluates the efficacy of digital cognitive behavioural therapy for insomnia (Sleepio) in chronic stroke survivors. Half of the participants will receive access to the digital (online) programme, half will receive a leaflet with sleep hygiene information. 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 and Sleep hygiene information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 14 Feb 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participant is willing and able to give informed consent for participation in the study.
- At least 18 years of age
- At least 3 months post stroke
- Interest in improving sleep
- Can understand verbal and written English well enough to engage with the programme and study procedures (with assistance from carer if needed).
- Reliable access to internet
- Currently living in the United Kingdom
- Current stable health
Who cannot join
- Serious physical health concerns with surgery scheduled in the next 5 months
- Undergoing a psychological treatment programme for insomnia (with a health professional or online)
- Pregnancy
- Uncontrolled seizures
- Untreated diagnosed obstructive sleep apnoea
- Habitual night shift, evening or rotating shift-workers
- Other serious clinical condition that may affect participation in the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, OX3 9DU
About this study
Official title: An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
This study evaluates the efficacy of digital cognitive behavioural therapy for insomnia (Sleepio) in chronic stroke survivors. Half of the participants will receive access to the digital (online) programme, half will receive a leaflet with sleep hygiene information. The primary outcome will be changes in sleep quality, assessed as the score on the Sleep Condition Indicator.
Read the detailed description
Stroke is one of the leading causes of adult disability. Many stroke survivors report difficulties with sleep and our current research confirms this, indicating that chronic community dwelling stroke survivors experience poorer self-reported and objective sleep quality than age matched healthy controls.
"Sleepio" is an online Cognitive Behavioural Therapy for Insomnia (CBT-I) programme. The efficacy of this intervention has been demonstrated in people with chronic insomnia but has not yet been tested in people with stroke. The study therefore aims to determine whether digital CBT-I is effective for improving sleep quality in chronic stroke survivors. Participants will be randomised to receive either digital (online) CBT-I or a leaflet with sleep hygiene information. The primary outcome is the change in self-reported sleep quality, assessed using the Sleep Condition Indicator. Secondary outcomes include changes in sleep fragmentation and wake after sleep onset assessed with actigraphy, self-reported sleep onset latency from the sleep diaries, anxiety and depression using the PHQ9 and GAD7, quality of life using the SIS-8 and EQ-5D-5L as well as changes in healthcare costs during the 8 week follow up.
- Conditions
- Stroke
- Being tested
- Digital cognitive behavioural therapy for insomnia, Sleep hygiene information
- Keywords
- Sleep, Rehabilitation, Digital, Cognitive Behavioural Therapy for Insomnia
- 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 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online
Sleep hygiene informationBehavioural
A leaflet detailing advice to improve sleep through changes in sleep hygiene
| Study group | Role | What they receive |
|---|---|---|
| Digital CBT-I | Experimental | 6 weeks digital (online) cognitive behavioural therapy for insomnia Receives: Behavioral: Digital cognitive behavioural therapy for insomnia |
| Sleep hygiene information | Active comparator | Leaflet of sleep hygiene information Receives: Behavioral: Sleep hygiene information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score and sex using Analysis of Covariance
Measured: 8 weeks
Secondary outcomes (12)
Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score
Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance.
Measured: 16 weeks
Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline
Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software which does the calculation the definition of sleep fragmentation index is "the sum of the Mobile time (%)' and the 'Immobile bouts <=1min (%)".There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance.
Measured: 8 weeks
Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline
Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software that does the calculation, the definition of sleep fragmentation index is "the sum of the Mobile time (%)' and the 'Immobile bouts <=1min (%)".There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Measured: 16 weeks
Wake After Sleep Onset at Post-intervention Adjusted for Baseline
Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Measured: 8 weeks
Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline
Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance.
Measured: 16 weeks
Change in Sleep Onset Latency
Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality
Measured: 8 weeks
Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline
PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Measured: 8 weeks
Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline
PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Measured: 16 weeks
Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline
GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Measured: 8 weeks
Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline
GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Measured: 16 weeks
Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline
SIS-8 index, range 0-100, higher values less impact of stroke on quality of life. Assessed at baseline and post-interventin. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance
Measured: 8 weeks
Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline
SIS-8 index, range 0-100, higher values indicate less impact of stroke on quality of life. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start14 Feb 2020
- Primary completion16 Sep 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Participants will be randomised (1:1 ratio) to the intervention or control group, using a computer generated minimisation method, with minimisation of between groups differences in age and baseline self-reported sleep quality (sleep condition indicator score)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Big Health Inc.
- Responsible party
- Sponsor
- Investigators
- Heidi Johansen-Berg, PhD, Principal investigator, University of Oxford, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04272892
- Sponsor's protocol ID
- INSPIRES
- Acronym
- INSPIRES
- Status last verified
- Jul 2021
- First submitted
- 13 Feb 2020
- Last updated
- 12 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Fleming MK, Smejka T, Macey E, Luengo-Fernandez R, Henry AL, Robinson B, Kyle SD, Espie CA, Johansen-Berg H. Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia. J Sleep Res. 2024 Apr;33(2):e13971. doi: 10.1111/jsr.13971. Epub 2023 Jul 5.
PubMed 37407096
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
- ClinicalTrials.gov ID
- NCT04272892
- Acronym / sponsor ID
- INSPIRES / INSPIRES
- Conditions
- Stroke
- Keywords
- Sleep, Rehabilitation, Digital, Cognitive Behavioural Therapy for Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Big Health Inc.
- Study start
- 14 Feb 2020 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Posted 12 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy of digital cognitive behavioural therapy for insomnia (Sleepio) in chronic stroke survivors. Half of the participants will receive access to the digital (online) programme, half will receive a leaflet with sleep hygiene information. The primary outcome will be changes in sleep quality, assessed as the score on the Sleep Condition Indicator.
Detailed description
Stroke is one of the leading causes of adult disability. Many stroke survivors report difficulties with sleep and our current research confirms this, indicating that chronic community dwelling stroke survivors experience poorer self-reported and objective sleep quality than age matched healthy controls.
"Sleepio" is an online Cognitive Behavioural Therapy for Insomnia (CBT-I) programme. The efficacy of this intervention has been demonstrated in people with chronic insomnia but has not yet been tested in people with stroke. The study therefore aims to determine whether digital CBT-I is effective for improving sleep quality in chronic stroke survivors. Participants will be randomised to receive either digital (online) CBT-I or a leaflet with sleep hygiene information. The primary outcome is the change in self-reported sleep quality, assessed using the Sleep Condition Indicator. Secondary outcomes include changes in sleep fragmentation and wake after sleep onset assessed with actigraphy, self-reported sleep onset latency from the sleep diaries, anxiety and depression using the PHQ9 and GAD7, quality of life using the SIS-8 and EQ-5D-5L as well as changes in healthcare costs during the 8 week follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomised (1:1 ratio) to the intervention or control group, using a computer generated minimisation method, with minimisation of between groups differences in age and baseline self-reported sleep quality (sleep condition indicator score)
| Arm | Type | Receives |
|---|---|---|
| Digital CBT-I | Experimental | Behavioral: Digital cognitive behavioural therapy for insomnia6 weeks digital (online) cognitive behavioural therapy for insomnia |
| Sleep hygiene information | Active comparator | Behavioral: Sleep hygiene informationLeaflet of sleep hygiene information |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant is willing and able to give informed consent for participation in the study.
- At least 18 years of age
- At least 3 months post stroke
- Interest in improving sleep
- Can understand verbal and written English well enough to engage with the programme and study procedures (with assistance from carer if needed).
Key exclusion criteria (7 listed)
- Serious physical health concerns with surgery scheduled in the next 5 months
- Undergoing a psychological treatment programme for insomnia (with a health professional or online)
- Pregnancy
- Uncontrolled seizures
- Untreated diagnosed obstructive sleep apnoea
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 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online | Behavioural | Digital CBT-I |
| Sleep hygiene informationA leaflet detailing advice to improve sleep through changes in sleep hygiene | Behavioural | Sleep hygiene information |
Primary outcome
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
Time frame: 8 weeks
Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score and sex using Analysis of Covariance
12 secondary outcomes
Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score
Time frame: 16 weeks
Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline
Time frame: 8 weeks
Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline
Time frame: 16 weeks
Wake After Sleep Onset at Post-intervention Adjusted for Baseline
Time frame: 8 weeks
Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline
Time frame: 16 weeks
Change in Sleep Onset Latency
Time frame: 8 weeks
Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline
Time frame: 8 weeks
Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline
Time frame: 16 weeks
Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline
Time frame: 8 weeks
Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline
Time frame: 16 weeks
Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline
Time frame: 8 weeks
Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline
Time frame: 16 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37407096Fleming MK, Smejka T, Macey E, Luengo-Fernandez R, Henry AL, Robinson B, Kyle SD, Espie CA, Johansen-Berg H. Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia. J Sleep Res. 2024 Apr;33(2):e13971. doi: 10.1111/jsr.13971. Epub 2023 Jul 5.
- Individual participant dataSharing planned: Yes. De-identified data are available upon reasonable request
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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. This study is not recruiting at the moment.
Heidi Johansen-Berg, PhD principal investigator
University of Oxford, UK
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 and Sleep hygiene information 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 8 inclusion and 7 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: finished, as of the sponsor's last update on 12 Sep 2025. 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?
Yes. Results are posted in the registry (first posted 12 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex (time frame: 8 weeks). 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 NCT04272892, 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 12 Sep 2025.