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: Active, not recruiting
• 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
• Genders Eligible for Study: All

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
Change in Sleep Condition Indicator score	Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maintenance of change in Sleep Condition Indicator score	Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality	16 weeks
Change in sleep fragmentation	Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep	8 weeks
Maintenance of change in sleep fragmentation	Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep	16 weeks
Change in wake after sleep onset	Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep	8 weeks
Maintenance of change in wake after sleep onset	Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep	16 weeks
Change in sleep onset latency	Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality	8 weeks
Maintenance of change in sleep onset latency	Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality	16 weeks
Change in self-reported depression	Change in PHQ9, range 0-20, higher values indicate more depressive symptoms	8 weeks
Maintenance of change in self-reported depression	Change in PHQ9, range 0-20, higher values indicate more depressive symptoms	16 weeks
Change in self-reported anxiety	Change in GAD7, range 0-21, higher values indicate more anxiety symptoms	8 weeks
Maintenance of change in self-reported anxiety	Change in GAD7, range 0-21, higher values indicate more anxiety symptoms	16 weeks
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
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

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

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): 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 (Actual): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 20, 2021
• 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: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System 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