Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 1:37 PM
Study NCT ID:
NCT04272892
Status:
COMPLETED
Last Update Posted:
2025-09-12
First Post:
2020-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving Sleep in Rehabilitation After Stroke
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INSPIRES
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.
"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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: