Trial Outcomes & Findings for Improving Sleep in Rehabilitation After Stroke (NCT NCT04272892)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

86 participants

Primary outcome timeframe

8 weeks

Results posted on

2025-09-12

Participant Flow

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

Participant milestones

Participant milestones
Measure	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	Sleep Hygiene Information Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene
Overall Study STARTED	48	36
Overall Study Post-intervention Assessment	35	33
Overall Study COMPLETED	34	33
Overall Study NOT COMPLETED	14	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Digital CBT-I n=48 Participants 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	Sleep Hygiene Information n=36 Participants Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene	Total n=84 Participants Total of all reporting groups
Age, Continuous	58.5 years STANDARD_DEVIATION 12.7 • n=48 Participants	58.7 years STANDARD_DEVIATION 14.7 • n=36 Participants	58.6 years STANDARD_DEVIATION 13.5 • n=84 Participants
Sex: Female, Male Female	17 Participants n=48 Participants	22 Participants n=36 Participants	39 Participants n=84 Participants
Sex: Female, Male Male	31 Participants n=48 Participants	14 Participants n=36 Participants	45 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	48 participants n=48 Participants	36 participants n=36 Participants	84 participants n=84 Participants
Time since most recent stroke, years	6 years STANDARD_DEVIATION 5 • n=48 Participants	6 years STANDARD_DEVIATION 5 • n=36 Participants	6 years STANDARD_DEVIATION 5 • n=84 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Intention to treat population, using multiple imputation. Mean and standard deviation are pooled across original (complete case) data and 5 imputations

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

Outcome measures

Outcome measures
Measure	Digital CBT-I n=48 Participants 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	Sleep Hygiene Information n=36 Participants Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex	18.06 score on a scale Interval 16.47 to 19.66	14.72 score on a scale Interval 13.05 to 16.39

SECONDARY outcome

Timeframe: 16 weeks

Population: Complete case analysis

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.

Outcome measures

Outcome measures
Measure	Digital CBT-I n=34 Participants 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	Sleep Hygiene Information n=33 Participants Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene
Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score	18.9 score on a scale Interval 16.8 to 21.0	16.0 score on a scale Interval 13.9 to 18.2

SECONDARY outcome

Timeframe: 8 weeks

Population: Complete case analysis population

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.

Outcome measures

Outcome measures
Measure	Digital CBT-I n=32 Participants 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	Sleep Hygiene Information n=27 Participants Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene
Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline	30.8 index (no units) Interval 27.6 to 34.1	32.1 index (no units) Interval 28.6 to 35.6

SECONDARY outcome

Timeframe: 16 weeks

Population: Complete case analysis population

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

Outcome measures

Outcome measures
Measure	Digital CBT-I n=32 Participants 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	Sleep Hygiene Information n=27 Participants Leaflet of sleep hygiene information Sleep hygiene information: A leaflet detailing advice to improve sleep through changes in sleep hygiene
Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline	29.3 index (no units) Interval 26.5 to 32.0	33.8 index (no units) Interval 30.8 to 36.8

SECONDARY outcome

Timeframe: 8 weeks

Population: Complete case analysis population

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