Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2026-01-04 @ 8:35 AM
Study NCT ID:
NCT04272892
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2020-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Improving Sleep in Rehabilitation After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'melanie.fleming@ndcn.ox.ac.uk', 'phone': '+441865611461', 'title': 'Dr Melanie Fleming', 'organization': 'University of Oxford'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '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.', 'eventGroups': [{'id': 'EG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online', 'otherNumAtRisk': 34, 'deathsNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene', 'otherNumAtRisk': 33, 'deathsNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '18.06', 'groupId': 'OG000', 'lowerLimit': '16.47', 'upperLimit': '19.66'}, {'value': '14.72', 'groupId': 'OG001', 'lowerLimit': '13.05', 'upperLimit': '16.39'}]}]}], 'analyses': [{'pValue': '<0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.35', 'pValueComment': 'p values are calculated for original data (complete case) and each of the 5 imputed datasets. The p value range was 0.002 - 0.020. This is not multiple statistical analyses- it is just one with multiple imputations.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Degrees of freedom for original data (complete case): 1,64. Degrees of freedom for imputed datasets: 1,80'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intention to treat population, using multiple imputation. Mean and standard deviation are pooled across original (complete case) data and 5 imputations'}, {'type': 'SECONDARY', 'title': 'Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '18.9', 'groupId': 'OG000', 'lowerLimit': '16.8', 'upperLimit': '21.0'}, {'value': '16.0', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '18.2'}]}]}], 'analyses': [{'pValue': '0.059', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.86', 'ciLowerLimit': '-.106', 'ciUpperLimit': '5.822', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of score at 8 week follow up with baseline score as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'SECONDARY', 'title': 'Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000', 'lowerLimit': '27.6', 'upperLimit': '34.1'}, {'value': '32.1', 'groupId': 'OG001', 'lowerLimit': '28.6', 'upperLimit': '35.6'}]}]}], 'analyses': [{'pValue': '0.596', 'groupIds': ['OG000'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.3', 'ciLowerLimit': '-3.5', 'ciUpperLimit': '6.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of sleep fragmentation at post-intervention with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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.', 'unitOfMeasure': 'index (no units)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '29.3', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '32.0'}, {'value': '33.8', 'groupId': 'OG001', 'lowerLimit': '30.8', 'upperLimit': '36.8'}]}]}], 'analyses': [{'pValue': '0.031', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.5', 'ciLowerLimit': '.431', 'ciUpperLimit': '8.612', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of sleep fragmentation at 8 week follow up with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': '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', 'unitOfMeasure': 'index (no units)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Wake After Sleep Onset at Post-intervention Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000', 'lowerLimit': '47', 'upperLimit': '59'}, {'value': '54', 'groupId': 'OG001', 'lowerLimit': '48', 'upperLimit': '60'}]}]}], 'analyses': [{'pValue': '0.885', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.6', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '9.1', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of wake after sleep onset post-intervention with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000', 'lowerLimit': '43', 'upperLimit': '55'}, {'value': '57', 'groupId': 'OG001', 'lowerLimit': '50', 'upperLimit': '63'}]}]}], 'analyses': [{'pValue': '0.077', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8', 'ciLowerLimit': '-1', 'ciUpperLimit': '17', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of wake after sleep onset at 8 week follow up with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': '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.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Change in Sleep Onset Latency', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '13', 'upperLimit': '24'}, {'value': '28', 'groupId': 'OG001', 'lowerLimit': '23', 'upperLimit': '34'}]}]}], 'analyses': [{'pValue': '0.014', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10', 'ciLowerLimit': '2', 'ciUpperLimit': '18', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of sleep onset latency (median of 7 nights) at end of intervention with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '4.7', 'upperLimit': '7.1'}, {'value': '7.7', 'groupId': 'OG001', 'lowerLimit': '6.6', 'upperLimit': '8.9'}]}]}], 'analyses': [{'pValue': '0.03', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '.18', 'ciUpperLimit': '3.5', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of PHQ9 score post-intervention with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '5.93', 'groupId': 'OG000', 'lowerLimit': '4.43', 'upperLimit': '7.43'}, {'value': '8.22', 'groupId': 'OG001', 'lowerLimit': '6.7', 'upperLimit': '9.75'}]}]}], 'analyses': [{'pValue': '0.036', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.29', 'ciLowerLimit': '.149', 'ciUpperLimit': '4.44', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of PHQ9 score at 8 week follow up with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '5.28', 'groupId': 'OG000', 'lowerLimit': '4.14', 'upperLimit': '6.42'}, {'value': '6.90', 'groupId': 'OG001', 'lowerLimit': '5.72', 'upperLimit': '8.06'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.61', 'ciLowerLimit': '-0.03', 'ciUpperLimit': '3.25', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of GAD7 post-intervention, with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '5.66', 'groupId': 'OG000', 'lowerLimit': '4.41', 'upperLimit': '6.91'}, {'value': '6.75', 'groupId': 'OG001', 'lowerLimit': '5.48', 'upperLimit': '8.01'}]}]}], 'analyses': [{'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.09', 'ciLowerLimit': '-.70', 'ciUpperLimit': '2.87', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of GAD7 at 8 week follow up, with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '51.8', 'groupId': 'OG000', 'lowerLimit': '49.0', 'upperLimit': '54.6'}, {'value': '50.4', 'groupId': 'OG001', 'lowerLimit': '47.5', 'upperLimit': '53.3'}]}]}], 'analyses': [{'pValue': '0.502', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.39', 'ciLowerLimit': '-5.51', 'ciUpperLimit': '2.73', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of SIS index at post-intervention, with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'SECONDARY', 'title': 'Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'OG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'classes': [{'categories': [{'measurements': [{'value': '52.0', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '55.0'}, {'value': '52.1', 'groupId': 'OG001', 'lowerLimit': '49.5', 'upperLimit': '54.8'}]}]}], 'analyses': [{'pValue': '0.924', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '.183', 'ciLowerLimit': '-3.63', 'ciUpperLimit': '4.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'ANCOVA of SIS index at 8 week follow up, with baseline as covariate, effect of group'}], 'paramType': 'MEAN', 'timeFrame': '16 weeks', 'description': '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', 'unitOfMeasure': 'score on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'complete case analysis population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cost Effectiveness', 'timeFrame': '16 weeks', 'description': 'Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'FG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'Post-intervention Assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'comment': '8 week follow-up, defined as 8-weeks following the post-intervention assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': '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'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia\n\nDigital cognitive behavioural therapy for insomnia: 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online'}, {'id': 'BG001', 'title': 'Sleep Hygiene Information', 'description': 'Leaflet of sleep hygiene information\n\nSleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '58.5', 'spread': '12.7', 'groupId': 'BG000'}, {'value': '58.7', 'spread': '14.7', 'groupId': 'BG001'}, {'value': '58.6', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Years', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Time since most recent stroke, years', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '84', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'spread': '5', 'groupId': 'BG000'}, {'value': '6', 'spread': '5', 'groupId': 'BG001'}, {'value': '6', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-30', 'size': 227197, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2022-12-16T13:32', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': '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'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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)'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2020-02-13', 'resultsFirstSubmitDate': '2024-03-26', 'studyFirstSubmitQcDate': '2020-02-13', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-22', 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost Effectiveness', 'timeFrame': '16 weeks', 'description': 'Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems'}], 'primaryOutcomes': [{'measure': 'Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex', 'timeFrame': '8 weeks', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score', 'timeFrame': '16 weeks', 'description': '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.'}, {'measure': 'Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline', 'timeFrame': '8 weeks', 'description': '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.'}, {'measure': 'Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline', 'timeFrame': '16 weeks', 'description': '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'}, {'measure': 'Wake After Sleep Onset at Post-intervention Adjusted for Baseline', 'timeFrame': '8 weeks', 'description': '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'}, {'measure': 'Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline', 'timeFrame': '16 weeks', 'description': '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.'}, {'measure': 'Change in Sleep Onset Latency', 'timeFrame': '8 weeks', 'description': 'Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality'}, {'measure': 'Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline', 'timeFrame': '8 weeks', 'description': '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'}, {'measure': 'Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline', 'timeFrame': '16 weeks', 'description': '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'}, {'measure': 'Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline', 'timeFrame': '8 weeks', 'description': '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'}, {'measure': 'Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline', 'timeFrame': '16 weeks', 'description': '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'}, {'measure': 'Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline', 'timeFrame': '8 weeks', 'description': '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'}, {'measure': 'Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline', 'timeFrame': '16 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sleep', 'Rehabilitation', 'Digital', 'Cognitive Behavioural Therapy for Insomnia'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '37407096', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\n"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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* At least 18 years of age\n* At least 3 months post stroke\n* Interest in improving sleep\n* Can understand verbal and written English well enough to engage with the programme and study procedures (with assistance from carer if needed).\n* Reliable access to internet\n* Currently living in the United Kingdom\n* Current stable health\n\nExclusion Criteria:\n\n* Serious physical health concerns with surgery scheduled in the next 5 months\n* Undergoing a psychological treatment programme for insomnia (with a health professional or online)\n* Pregnancy\n* Uncontrolled seizures\n* Untreated diagnosed obstructive sleep apnoea\n* Habitual night shift, evening or rotating shift-workers\n* Other serious clinical condition that may affect participation in the study'}, 'identificationModule': {'nctId': 'NCT04272892', 'acronym': 'INSPIRES', 'briefTitle': 'Improving Sleep in Rehabilitation After Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Oxford'}, 'officialTitle': 'An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.', 'orgStudyIdInfo': {'id': 'INSPIRES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital CBT-I', 'description': '6 weeks digital (online) cognitive behavioural therapy for insomnia', 'interventionNames': ['Behavioral: Digital cognitive behavioural therapy for insomnia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sleep hygiene information', 'description': 'Leaflet of sleep hygiene information', 'interventionNames': ['Behavioral: Sleep hygiene information']}], 'interventions': [{'name': 'Digital cognitive behavioural therapy for insomnia', 'type': 'BEHAVIORAL', 'otherNames': ['Sleepio'], 'description': '6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online', 'armGroupLabels': ['Digital CBT-I']}, {'name': 'Sleep hygiene information', 'type': 'BEHAVIORAL', 'description': 'A leaflet detailing advice to improve sleep through changes in sleep hygiene', 'armGroupLabels': ['Sleep hygiene information']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'OX3 9DU', 'city': 'Oxford', 'country': 'United Kingdom', 'facility': 'Wellcome Centre for Integrative Neuroimaging (WIN)', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}], 'overallOfficials': [{'name': 'Heidi Johansen-Berg, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Oxford, UK'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Following publication of results', 'ipdSharing': 'YES', 'description': 'De-identified data are available upon reasonable request', 'accessCriteria': 'Available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oxford', 'class': 'OTHER'}, 'collaborators': [{'name': 'Big Health Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}