Improving Sleep and Learning in Rehabilitation After Stroke, Part 2

Stroke Clinical Trial

— INSPIRES-2  

Official title:

Improving Sleep and Learning in Rehabilitation After Stroke, Part 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05511285
• Other study ID #: PID 16015
• Status: Recruiting
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: June 2026

Study information

• Verified date: November 2023
• Source: University of Oxford
• Contact: Melanie K Fleming, Dr
• Phone: 01865 611 461
• Email: melanie.fleming[@]ndcn.ox.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will explore whether sleep in stroke survivors is improved with digital cognitive behavioural therapy for insomnia (Sleepio), in comparison to treatment as usual, and will explore whether changes in sleep relate to changes in overnight consolidation of motor learning.

Description:

Stroke is one of the leading causes of adult disability. Rehabilitation of movement after stroke depends on motor learning. Motor learning involves not only improvement during practice but also offline improvement, or consolidation, that occurs after practice. Consolidation of learning depends on good sleep quality. However, sleep is disrupted long-term after stroke and patients with poorer sleep show worse rehabilitation outcomes. Cognitive behavioural therapy for insomnia (CBT) is the recommended first line treatment for sleep problems. "Sleepio" is a digital CBT programme which is effective across a range of clinical populations. This study aims to test the efficacy of digital CBT for reducing insomnia symptoms after stroke, in comparison with usual care alone. To explore the possibility that sleep interventions might enhance rehabilitation outcomes via their impact on consolidation of motor learning, the study will additionally test for differences in consolidation between groups, and explore whether changes in sleep measures are associated with changes in consolidation. Participants will be randomised to either receive digital CBT for insomnia (in addition to usual care) or receive treatment as usual alone (2:1 treatment to control ratio). The primary outcome is the score on the 8-item Sleep Condition Indicator, 10 weeks following randomisation. Secondary outcomes include behavioural measures of overnight motor consolidation assessed as the change in motor task performance from training to retest, sleep disruption assessed with actigraphy, and depression and fatigue using the Patient Health Questionnaire (PHQ9) and the Fatigue Severity Scale respectively. In addition to this, to explore the feasibility of delivering rehabilitation following the sleep improvement programme, an optional 4 weeks of upper limb motor training at home will be offered to all participants (regardless of group allocation) after follow-up. Outcomes of adherence to the training and upper limb function will be assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Willing and able to give informed consent for participation in the study
• Aged 18 years or above.
• Clinical diagnosis of stroke affecting the upper limb, with sufficient movement to perform the motor learning task
• Discharged from inpatient care
• Interest in accessing a programme with the aim of improving sleep quality
• Reliable access to the internet

Exclusion Criteria:

• Other neurological condition affecting movement (e.g. Parkinson's Disease, Multiple Sclerosis)
• Diagnosed, untreated, sleep disorder (e.g. Sleep Apnea)
• Uncontrolled seizures
• Planned inpatient admission (e.g. for rehabilitation) in the next 4 months that would impact ability to engage with the Sleepio programme
• Engagement in psychological therapy for insomnia in the past 12 months
• Pregnancy

Related Conditions & MeSH terms

• Stroke

Intervention

Behavioral:
• Digital Cognitive Behavioural Therapy for Insomnia
6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
University of Oxford	Big Health Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adherence of at home motor training	Assessment of number of sessions performed, number of repetitions etc.	14 weeks following randomisation
Other	Upper limb ability	Assessed with Action Research Arm Test, range 0-57, higher score indicates better upper limb ability	14 weeks following randomisation
Other	Upper limb function	Assessed with Box and Blocks Test, scored as the number of blocks transferred in 60 seconds	14 weeks following randomisation
Other	Upper limb dexterity	Assessed with Nine hole peg test, scored as the number of pegs placed in 30 seconds	14 weeks following randomisation
Primary	Sleep Condition Indicator	Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia	10 weeks after randomisation
Secondary	Change in motor performance from training to retest	Behavioural motor consolidation assessment, assessed as accuracy (range 0-50, higher numbers indicate better accuracy of motor performance)	10 weeks after randomisation
Secondary	Patient Health Questionnaire	Questionnaire assessing symptoms of depression, range 0-20, higher values indicate more depressive symptoms	10 weeks after randomisation
Secondary	Fatigue Severity Scale	Questionnaire assessing fatigue, range 9-63, higher score indicates more severe fatigue	10 weeks after randomisation
Secondary	Actigraphy	Wearable activity monitor used for assessing sleep disruption (Total Sleep Time, Wake After Sleep Onset, sleep fragmentation)	10 weeks after randomisation