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Completed

NCT Number: NCT04272892

Improving Sleep in Rehabilitation 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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellcome Centre for Integrative Neuroimaging (WIN)

Oxford, OX3 9DU, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital cognitive behavioural therapy for insomnia

Behavioral

6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online

Other names: Sleepio

Sleep hygiene information

Behavioral

A leaflet detailing advice to improve sleep through changes in sleep hygiene

Primary outcomes

  1. Sleep Condition Indicator Score at Post-intervention, Adjusted for Baseline Score and Sex

    Time frame: 8 weeks

    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

Secondary outcomes

  1. Sleep Condition Indicator Score at 8 Week Follow up Adjusted for Baseline Score

    Time frame: 16 weeks

    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.

  2. Sleep Fragmentation, Assessed at Post-intervention Adjusted for Baseline

    Time frame: 8 weeks

    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.

  3. Sleep Fragmentation at 8 Week Follow up Adjusted for Baseline

    Time frame: 16 weeks

    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

  4. Wake After Sleep Onset at Post-intervention Adjusted for Baseline

    Time frame: 8 weeks

    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

  5. Wake After Sleep Onset at 8 Week Follow up Adjusted for Baseline

    Time frame: 16 weeks

    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.

  6. Change in Sleep Onset Latency

    Time frame: 8 weeks

    Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality

  7. Self-reported Depression Post-intervention, Assessed as PHQ9 Score at Post-intervention Adjusted for Baseline

    Time frame: 8 weeks

    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. Self-reported Depression at 8 Week Follow up, Assessed as PHQ9 Score at 8 Week Follow up Adjusted for Baseline

    Time frame: 16 weeks

    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

  9. Self-reported Anxiety at Post-intervention, Assessed as GAD7 Score Post-intervention Adjusted for Baseline

    Time frame: 8 weeks

    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

  10. Self-reported Anxiety at 8 Week Follow up, Assessed as GAD7 Score at 8 Week Follow up Adjusted for Baseline

    Time frame: 16 weeks

    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

  11. Stroke Specific Quality of Life, Assessed as SIS Index Post-intervention Adjusted for Baseline

    Time frame: 8 weeks

    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

  12. Stroke Specific Quality of Life at 8 Week Follow up, Assessed as SIS Index at 8 Week Follow up Adjusted for Baseline

    Time frame: 16 weeks

    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

Other outcomes

  1. Cost Effectiveness

    Time frame: 16 weeks

    Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Big Health Inc.

Registry information

Official study title

An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.

Acronym: INSPIRES

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 17, 2020
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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