Clinical trial NCT04272892: Improving Sleep in Rehabilitation After Stroke
Official title: An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Sleep
Rehabilitation
Digital
Cognitive Behavioural Therapy for Insomnia
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Big Health Inc.
First posted: 2020-02-17
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomised (1:1 ratio) to the intervention or control group, using a computer generated minimisation method, with minimisation of between groups differences in age and baseline self-reported sleep quality (sleep condition indicator score)
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Change in Sleep Condition Indicator score
timeFrame: 8 weeks
Secondary outcomes:
measure: Maintenance of change in Sleep Condition Indicator score
timeFrame: 16 weeks
measure: Change in sleep fragmentation
timeFrame: 8 weeks
measure: Maintenance of change in sleep fragmentation
timeFrame: 16 weeks
measure: Change in wake after sleep onset
timeFrame: 8 weeks
measure: Maintenance of change in wake after sleep onset
timeFrame: 16 weeks
measure: Change in sleep onset latency
timeFrame: 8 weeks
measure: Maintenance of change in sleep onset latency
timeFrame: 16 weeks
measure: Change in self-reported depression
timeFrame: 8 weeks
measure: Maintenance of change in self-reported depression
timeFrame: 16 weeks
measure: Change in self-reported anxiety
timeFrame: 8 weeks
measure: Maintenance of change in self-reported anxiety
timeFrame: 16 weeks
measure: Change in stroke specific quality of life
timeFrame: 8 weeks
measure: Maintenance of change in stroke specific quality of life
timeFrame: 16 weeks
Other outcomes:
measure: Cost effectiveness
timeFrame: 16 weeks
Locations:
city: Oxford
country: United Kingdom
facility: Wellcome Centre for Integrative Neuroimaging (WIN)
Study officials:
affiliation: University of Oxford, UK
name: Heidi Johansen-Berg, PhD
role: PRINCIPAL_INVESTIGATOR
References: