Improving sleep and learning for stroke survivors
Improving Sleep and Learning in Rehabilitation After Stroke, Part 2
This study is testing if a digital sleep program can help stroke survivors sleep better and improve their learning for rehabilitation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford) |
| Trial ID | NCT05511285 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a digital cognitive behavioral therapy program for insomnia, called Sleepio, in enhancing sleep quality among stroke survivors. Participants will be randomly assigned to receive either the Sleepio program alongside usual care or usual care alone. The study aims to determine if improved sleep correlates with better overnight consolidation of motor learning, which is crucial for rehabilitation after a stroke. The primary outcome will be assessed using the Sleep Condition Indicator after 10 weeks, while secondary outcomes will focus on motor task performance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced a stroke affecting the upper limb and have sufficient movement to engage in motor learning tasks.
Not a fit: Patients with other neurological conditions, untreated sleep disorders, or those currently undergoing psychological therapy for insomnia may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve sleep quality and rehabilitation outcomes for stroke survivors.
How similar studies have performed: Previous studies have shown that cognitive behavioral therapy for insomnia can be effective in various clinical populations, suggesting potential success for this approach in stroke rehabilitation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Willing and able to give informed consent for participation in the study * Aged 18 years or above. * Clinical diagnosis of stroke affecting the upper limb, with sufficient movement to perform the motor learning task * Discharged from inpatient care * Interest in accessing a programme with the aim of improving sleep quality * Reliable access to the internet Exclusion Criteria: * Other neurological condition affecting movement (e.g. Parkinson's Disease, Multiple Sclerosis) * Diagnosed, untreated, sleep disorder (e.g. Sleep Apnea) * Uncontrolled seizures * Planned inpatient admission (e.g. for rehabilitation) in the next 4 months that would impact ability to engage with the Sleepio programme * Engagement in psychological therapy for insomnia in the past 12 months * Pregnancy
Where this trial is running
Oxford
- University of Oxford — Oxford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Melanie K Fleming, Dr — University of Oxford
- Study coordinator: Melanie K Fleming, Dr
- Email: melanie.fleming@ndcn.ox.ac.uk
- Phone: 01865 611 461
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.