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| Name | Class |
|---|---|
| Big Health Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital CBT-I | Experimental | 6 weeks digital (online) cognitive behavioural therapy for insomnia |
|
| Sleep hygiene information | Active Comparator | Leaflet of sleep hygiene information |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital cognitive behavioural therapy for insomnia | Behavioral | 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Effectiveness | Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems | 16 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Heidi Johansen-Berg, PhD | University of Oxford, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wellcome Centre for Integrative Neuroimaging (WIN) | Oxford | OX3 9DU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37407096 | Derived | 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. |
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De-identified data are available upon reasonable request
Following publication of results
Available upon reasonable request
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2 participants failed to undergo the baseline assessment following consent, and were not randomised to group. Therefore, although 86 participants consented, the total started in the study when divided by group is 84
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| ID | Title | Description |
|---|---|---|
| FG000 | Digital CBT-I | 6 weeks digital (online) cognitive behavioural therapy for insomnia Digital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online |
| FG001 | Sleep Hygiene Information | Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Digital CBT-I | 6 weeks digital (online) cognitive behavioural therapy for insomnia Digital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online |
| BG001 | Sleep Hygiene Information |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Years |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Intention to treat population, using multiple imputation. Mean and standard deviation are pooled across original (complete case) data and 5 imputations | Posted | Mean | 95% Confidence Interval | score on a scale | 8 weeks |
|
Adverse events could be reported to the research team at any time during the intervention or over the 8 weeks following the intervention. The length of the intervention was not prescribed, but on average it lasted 77 days. Therefore on average adverse events could be reported over a 19 week timescale, being 11 weeks (77 days average) for the intervention period plus the 8 week follow up period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Digital CBT-I | 6 weeks digital (online) cognitive behavioural therapy for insomnia Digital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Melanie Fleming | University of Oxford | +441865611461 | melanie.fleming@ndcn.ox.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Oct 30, 2020 | Dec 16, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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)
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Participants will be told that they will be assigned to one of two groups but will not be told whether one is hypothesised to be superior over another
| Sleep hygiene information | Behavioral | A leaflet detailing advice to improve sleep through changes in sleep hygiene |
|
| 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. |
| 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 | 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 | 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. | 16 weeks |
| Change in Sleep Onset Latency | Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality | 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 | 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 | 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 | 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 | 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 | 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 | 16 weeks |
Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time since most recent stroke, years | Mean | Standard Deviation | years |
|
| OG001 |
| Sleep Hygiene Information |
Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene |
|
|
|
| Secondary | 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. | Complete case analysis | Posted | Mean | 95% Confidence Interval | score on a scale | 16 weeks |
|
|
|
|
| Secondary | 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. | Complete case analysis population | Posted | Mean | 95% Confidence Interval | index (no units) | 8 weeks |
|
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|
|
| Secondary | 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 | Complete case analysis population | Posted | Mean | 95% Confidence Interval | index (no units) | 16 weeks |
|
|
|
|
| Secondary | 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 | Complete case analysis population | Posted | Mean | 95% Confidence Interval | minutes | 8 weeks |
|
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|
|
| Secondary | 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. | complete case analysis population | Posted | Mean | 95% Confidence Interval | minutes | 16 weeks |
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| Secondary | Change in Sleep Onset Latency | Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality | complete case analysis population | Posted | Mean | 95% Confidence Interval | minutes | 8 weeks |
|
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|
| Secondary | 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 | complete case analysis population | Posted | Mean | 95% Confidence Interval | score on a scale | 8 weeks |
|
|
|
|
| Secondary | 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 | complete case analysis population | Posted | Mean | 95% Confidence Interval | score on a scale | 16 weeks |
|
|
|
|
| Secondary | 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 | complete case analysis population | Posted | Mean | 95% Confidence Interval | score on a scale | 8 weeks |
|
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|
|
| Secondary | 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 | complete case analysis population | Posted | Mean | 95% Confidence Interval | score on a scale | 16 weeks |
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| Secondary | 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 | complete case analysis population | Posted | Mean | 95% Confidence Interval | score on a scale | 8 weeks |
|
|
|
|
| Secondary | 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 | complete case analysis population | Posted | Mean | 95% Confidence Interval | score on a scale | 16 weeks |
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| Other Pre-specified | Cost Effectiveness | Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems | Not Posted | 16 weeks | Participants |
| 0 |
| 34 |
| 0 |
| 34 |
| 0 |
| 34 |
| EG001 | Sleep Hygiene Information | Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene | 0 | 33 | 0 | 33 | 0 | 33 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |