Improving Sleep in Rehabilitation After Stroke

Stroke Clinical Trial

— INSPIRES  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04272892
• Other study ID #: INSPIRES
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 14, 2020
• Est. completion date: January 2022

Study information

• Verified date: July 2021
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: January 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Digital cognitive behavioural therapy for insomnia
6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online
• Sleep hygiene information
A leaflet detailing advice to improve sleep through changes in sleep hygiene

Locations

Country	Name	City	State
United Kingdom	Wellcome Centre for Integrative Neuroimaging (WIN)	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Big Health

Country where clinical trial is conducted

United Kingdom, 

Outcome

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