Improving Sleep in Rehabilitation After Stroke

Not Applicable

• Conditions: Stroke
• Interventions: Behavioral: Sleep hygiene information; Behavioral: Digital cognitive behavioural therapy for insomnia

• Registration Number: NCT04272892
• Lead Sponsor: University of Oxford

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.

Study Timeline

• Study First Submitted: 2020-02-13
• Study First Submitted QC: 2020-02-13
• Study Start: 2020-02-14
• Study First Posted: 2020-02-17
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Primary Completion: 2021-10
• Study Completion: 2022-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep hygiene information	Sleep hygiene information	Leaflet of sleep hygiene information
Digital CBT-I	Digital cognitive behavioural therapy for insomnia	6 weeks digital (online) cognitive behavioural therapy for insomnia

Primary Outcome Measures

Name	Time	Method
Change in Sleep Condition Indicator score	8 weeks	Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality

Secondary Outcome Measures

Name	Time	Method
Change in sleep onset latency	8 weeks	Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality
Maintenance of change in sleep onset latency	16 weeks	Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality
Maintenance of change in Sleep Condition Indicator score	16 weeks	Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality
Change in sleep fragmentation	8 weeks	Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep
Maintenance of change in sleep fragmentation	16 weeks	Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep
Change in wake after sleep onset	8 weeks	Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep
Maintenance of change in wake after sleep onset	16 weeks	Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep
Change in self-reported depression	8 weeks	Change in PHQ9, range 0-20, higher values indicate more depressive symptoms
Maintenance of change in self-reported depression	16 weeks	Change in PHQ9, range 0-20, higher values indicate more depressive symptoms
Change in self-reported anxiety	8 weeks	Change in GAD7, range 0-21, higher values indicate more anxiety symptoms
Maintenance of change in self-reported anxiety	16 weeks	Change in GAD7, range 0-21, higher values indicate more anxiety symptoms
Change in stroke specific quality of life	8 weeks	Change in SIS-8, range 0-40, higher values less impact of stroke on quality of life
Maintenance of change in stroke specific quality of life	16 weeks	Change in SIS-8, range 0-40, higher values indicate less impact of stroke on quality of life

Trial Locations

Locations (1)

Wellcome Centre for Integrative Neuroimaging (WIN); 🇬🇧 Oxford, United Kingdom