Improving Sleep in Rehabilitation After Stroke (INSPIRES)
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About
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.
Full description
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.
"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.
Enrollment
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Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
86 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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