Trial results evaluating digital cognitive behavioral therapy for insomnia (CBT-I) in chronic stroke survivors were posted on ClinicalTrials.gov on 2025-09-12. The intervention group demonstrated a statistically significant improvement in sleep quality, with a mean difference of 3.35 in the Sleep Condition Indicator score (p=0.021) post-intervention compared to a control group.
Background
Stroke can lead to a range of physical and cognitive impairments, and sleep disturbances are a common comorbidity that can hinder rehabilitation and overall recovery. Insomnia, in particular, can impact mood, cognitive function, and quality of life for stroke survivors. Addressing sleep issues is therefore a critical component of comprehensive post-stroke care. Digital cognitive behavioral therapy for insomnia (CBT-I) offers a scalable and accessible approach to managing sleep difficulties, potentially improving outcomes for individuals recovering from stroke.
Trial design
This completed study, designated as Phase NA, enrolled 86 participants with Stroke. The trial evaluated the efficacy of digital cognitive behavioral therapy for insomnia (Sleepio) in chronic stroke survivors. Participants were randomized into two groups: one received access to the digital (online) program, while the other received a leaflet with sleep hygiene information. The primary outcome was changes in sleep quality, assessed by the Sleep Condition Indicator score.
Key results
The trial reported key measurements and analyses related to sleep quality and fragmentation:
- Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex:
- Digital CBT-I group: mean score of 18.06.
- Sleep Hygiene Information group: mean score of 14.72.
- Analysis (ANCOVA): Mean Difference (Final Values) of 3.35, with a p-value of 0.021.
- Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score:
- Digital CBT-I group: mean score of 18.9.
- Sleep Hygiene Information group: mean score of 16.0.
- Analysis (ANCOVA): Mean Difference (Final Values) of 2.86 (95% Confidence Interval: -0.106 to 5.822), with a p-value of 0.059.
- Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline:
- Digital CBT-I group: mean index of 30.8.
- Sleep Hygiene Information group: mean index of 32.1.
- Analysis (ANCOVA): Mean Difference (Final Values) of 1.3 (95% Confidence Interval: -3.5 to 6.0), with a p-value of 0.596.
- Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline:
- Digital CBT-I group: mean index of 29.3.
- Sleep Hygiene Information group: mean index of 33.8.
- Analysis (ANCOVA): Mean Difference (Final Values) of 4.5 (95% Confidence Interval: 0.431 to 8.612), with a p-value of 0.031.
- Wake After Sleep Onset at Post-intervention Adjusted for Baseline:
- Digital CBT-I group: mean of 53 minutes.
- Sleep Hygiene Information group: mean of 54 minutes.
- Analysis (ANCOVA): Mean Difference (Final Values) of 0.6 (95% Confidence Interval: -7.8 to 9.1), with a p-value of 0.885.
- Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline:
- Digital CBT-I group: mean of 49 minutes.
- Sleep Hygiene Information group: mean of 57 minutes.
- Analysis (ANCOVA): Mean Difference (Final Values) of 8.0 (95% Confidence Interval: -1.0 to 17.0), with a p-value of 0.077.
What this means
The results suggest that digital CBT-I may be an effective intervention for improving sleep quality in chronic stroke survivors. A statistically significant improvement in the Sleep Condition Indicator score was observed immediately post-intervention for the digital CBT-I group compared to the sleep hygiene information group. Furthermore, a statistically significant reduction in sleep fragmentation was noted at the 8-week follow-up for the digital CBT-I group. While other measures like Wake After Sleep Onset showed numerical improvements, they did not reach statistical significance. These findings indicate that digital CBT-I could offer a valuable, accessible tool to address common sleep disturbances in stroke rehabilitation, potentially enhancing recovery and patient well-being.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04272892, titled "Improving Sleep in Rehabilitation After Stroke", were posted on 2025-09-12 on clinicaltrials.gov.