Improving Sleep in Rehabilitation After Stroke
INSPIRES
An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
1 other identifier
interventional
86
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable stroke
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2020
CompletedStudy Start
First participant enrolled
February 14, 2020
CompletedFirst Posted
Study publicly available on registry
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2022
CompletedResults Posted
Study results publicly available
September 12, 2025
CompletedSeptember 12, 2025
July 1, 2021
1.6 years
February 13, 2020
March 26, 2024
August 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex
Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score and sex using Analysis of Covariance
8 weeks
Secondary Outcomes (12)
Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score
16 weeks
Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline
8 weeks
Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline
16 weeks
Wake After Sleep Onset at Post-intervention Adjusted for Baseline
8 weeks
Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline
16 weeks
- +7 more secondary outcomes
Other Outcomes (1)
Cost Effectiveness
16 weeks
Study Arms (2)
Digital CBT-I
EXPERIMENTAL6 weeks digital (online) cognitive behavioural therapy for insomnia
Sleep hygiene information
ACTIVE COMPARATORLeaflet of sleep hygiene information
Interventions
6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online
A leaflet detailing advice to improve sleep through changes in sleep hygiene
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Oxfordlead
- Big Health Inc.collaborator
Study Sites (1)
Wellcome Centre for Integrative Neuroimaging (WIN)
Oxford, OX3 9DU, United Kingdom
Related Publications (1)
Fleming MK, Smejka T, Macey E, Luengo-Fernandez R, Henry AL, Robinson B, Kyle SD, Espie CA, Johansen-Berg H. Improving sleep after stroke: A randomised controlled trial of digital cognitive behavioural therapy for insomnia. J Sleep Res. 2024 Apr;33(2):e13971. doi: 10.1111/jsr.13971. Epub 2023 Jul 5.
PMID: 37407096DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Melanie Fleming
- Organization
- University of Oxford
Study Officials
- PRINCIPAL INVESTIGATOR
Heidi Johansen-Berg, PhD
University of Oxford, UK
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be told that they will be assigned to one of two groups but will not be told whether one is hypothesised to be superior over another
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2020
First Posted
February 17, 2020
Study Start
February 14, 2020
Primary Completion
September 16, 2021
Study Completion
January 1, 2022
Last Updated
September 12, 2025
Results First Posted
September 12, 2025
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Following publication of results
- Access Criteria
- Available upon reasonable request
De-identified data are available upon reasonable request