N/A N=84 Randomized Single-blind Treatment

Improving Sleep in Rehabilitation After Stroke

Stroke

Bottom Line

View on ClinicalTrials.gov: NCT04272892 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex — 18.06; 14.72 score on a scale — p=<0.021

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Digital cognitive behavioural therapy for insomnia (Behavioral); Sleep hygiene information (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Oxford
Primary completion: Sep 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex	18.06; 14.72	<0.021 sig
SECONDARY Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score	18.9; 16.0	0.059
SECONDARY Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline	30.8; 32.1	0.596
SECONDARY Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline	29.3; 33.8	0.031 sig
SECONDARY Wake After Sleep Onset at Post-intervention Adjusted for Baseline	53; 54	0.885
SECONDARY Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline	49; 57	0.077
SECONDARY Change in Sleep Onset Latency	18; 28	0.014 sig
SECONDARY Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline	5.9; 7.7	0.03 sig
SECONDARY Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline	5.93; 8.22	0.036 sig
SECONDARY Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline	5.28; 6.90	0.054
SECONDARY Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline	5.66; 6.75	0.229
SECONDARY Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline	51.8; 50.4	0.502
SECONDARY Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline	52.0; 52.1	0.924

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. The primary outcome will be changes in sleep quality, assessed as the score on the Sleep Condition Indicator.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04272892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.