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.

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Digital cognitive behavioural therapy for insomnia; Behavioral: Sleep hygiene information

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX3 9DU
    • Wellcome Centre for Integrative Neuroimaging (WIN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Digital CBT-I; 6 weeks digital (online) cognitive behavioural therapy for insomnia	Behavioral: Digital cognitive behavioural therapy for insomnia; 6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online; Other Names: Sleepio
Active Comparator: Sleep hygiene information; Leaflet of sleep hygiene information	Behavioral: Sleep hygiene information; A leaflet detailing advice to improve sleep through changes in sleep hygiene

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score	Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance.	16 weeks
Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline	Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software which does the calculation the definition of sleep fragmentation index is "the sum of the Mobile time (%)' and the 'Immobile bouts <=1min (%)".There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance.	8 weeks
Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline	Sleep fragmentation assessed using actigraphy. Higher values indicate more disrupted (worse) sleep. The minimum value is 0. There is no specified maximum value. According to the manual for the software that does the calculation, the definition of sleep fragmentation index is "the sum of the Mobile time (%)' and the 'Immobile bouts <=1min (%)".There are no units associated with sleep fragmentation. The values are never presented in the literature or elsewhere as a percentage and therefore they are not presented as a percentage here. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance	16 weeks
Wake After Sleep Onset at Post-intervention Adjusted for Baseline	Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance	8 weeks
Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline	Wake after sleep onset assessed using actigraphy, higher values (minutes) indicate more disrupted sleep. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance.	16 weeks
Change in Sleep Onset Latency	Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality	8 weeks
Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline	PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance	8 weeks
Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline	PHQ9 score, range 0-20, higher values indicate more depressive symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance	16 weeks
Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline	GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and post-intervention. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance	8 weeks
Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline	GAD7 score, range 0-21, higher values indicate more anxiety symptoms. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance	16 weeks
Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline	SIS-8 index, range 0-100, higher values less impact of stroke on quality of life. Assessed at baseline and post-interventin. Outcome is post-intervention score after adjustment for baseline score using Analysis of Covariance	8 weeks
Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline	SIS-8 index, range 0-100, higher values indicate less impact of stroke on quality of life. Assessed at baseline and 8 week follow up. Outcome is follow up score after adjustment for baseline score using Analysis of Covariance	16 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost Effectiveness	Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems	16 weeks

Collaborators and Investigators

• Sponsor: University of Oxford
• Collaborators: Big Health Inc.
• Investigators: Principal Investigator: Heidi Johansen-Berg, PhD, University of Oxford, UK

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Actual): September 16, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: February 13, 2020
• First Submitted That Met QC Criteria: February 13, 2020
• First Posted (Actual): February 17, 2020

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Rehabilitation; Sleep; Digital; Cognitive Behavioural Therapy for Insomnia
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: INSPIRES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data are available upon reasonable request
• IPD Sharing Time Frame: Following publication of results
• IPD Sharing Access Criteria: Available upon reasonable request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No