Improving Sleep and Learning in Rehabilitation After Stroke, Part 2 (INSPIRES-2)

April 9, 2024 updated by: University of Oxford
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Behavioural: Digital cognitive behavioural therapy for insomnia
6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.
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.
Other Names:
  • Sleepio
No Intervention: Treatment as usual
Participants will receive treatment as usual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Condition Indicator
Time Frame: 10 weeks after randomisation
Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia
10 weeks after randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in motor performance from training to retest
Time Frame: 10 weeks after randomisation
Behavioural motor consolidation assessment, assessed as accuracy (range 0-50, higher numbers indicate better accuracy of motor performance)
10 weeks after randomisation
Patient Health Questionnaire
Time Frame: 10 weeks after randomisation
Questionnaire assessing symptoms of depression, range 0-20, higher values indicate more depressive symptoms
10 weeks after randomisation
Fatigue Severity Scale
Time Frame: 10 weeks after randomisation
Questionnaire assessing fatigue, range 9-63, higher score indicates more severe fatigue
10 weeks after randomisation
Actigraphy
Time Frame: 10 weeks after randomisation
Wearable activity monitor used for assessing sleep disruption (Total Sleep Time, Wake After Sleep Onset, sleep fragmentation)
10 weeks after randomisation

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence of at home motor training
Time Frame: 14 weeks following randomisation
Assessment of number of sessions performed, number of repetitions etc.
14 weeks following randomisation
Upper limb ability
Time Frame: 14 weeks following randomisation
Assessed with Action Research Arm Test, range 0-57, higher score indicates better upper limb ability
14 weeks following randomisation
Upper limb function
Time Frame: 14 weeks following randomisation
Assessed with Box and Blocks Test, scored as the number of blocks transferred in 60 seconds
14 weeks following randomisation
Upper limb dexterity
Time Frame: 14 weeks following randomisation
Assessed with Nine hole peg test, scored as the number of pegs placed in 30 seconds
14 weeks following randomisation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

Big Health Inc.

Investigators

  • Principal Investigator: Melanie K Fleming, Dr, University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 13, 2022

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 16, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

April 10, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID 16015

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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