Improving Sleep and Learning in Rehabilitation After Stroke, Part 2

NCT05511285 | Recruiting

• 1 other identifier: PID 16015
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Stroke

Keywords

Sleep; Rehabilitation; Digital; Cognitive Behavioural Therapy for Insomnia; Motor consolidation

Outcome Measures

Primary Outcomes (1)

• Sleep Condition Indicator

  Questionnaire assessing self-reported insomnia symptoms, range 0-32, higher numbers indicate less symptoms of insomnia

  10 weeks after randomisation

Secondary Outcomes (4)

• Change in motor performance from training to retest

  10 weeks after randomisation

• Patient Health Questionnaire

  10 weeks after randomisation

• Fatigue Severity Scale

  10 weeks after randomisation

• Actigraphy

  10 weeks after randomisation

Other Outcomes (4)

• Adherence of at home motor training

  14 weeks following randomisation

• Upper limb ability

  14 weeks following randomisation

• Upper limb function

  14 weeks following randomisation

Study Arms (2)

Behavioural: Digital cognitive behavioural therapy for insomnia

EXPERIMENTAL

6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online.

Behavioral: Digital Cognitive Behavioural Therapy for Insomnia

Treatment as usual

NO INTERVENTION

Participants will receive treatment as usual.

Interventions

Digital Cognitive Behavioural Therapy for Insomnia BEHAVIORAL

6-10 weeks of digital cognitive behavioural therapy for insomnia (Sleepio) delivered online, in addition to usual care.

Also known as: Sleepio

Behavioural: Digital cognitive behavioural therapy for insomnia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Big Health Inc.: collaborator

Study Sites (1)

University of Oxford

Oxford, OX39DU, United Kingdom

RECRUITING

Related Publications (1)

• Weightman M, Robinson B, Fallows R, Henry AL, Kyle SD, Garratt E, Pick A, Teal R, Ajina S, Demeyere N, Espie CA, Seymour B, Johansen-Berg H, Fleming MK. Improving sleep and learning in rehabilitation after stroke, part 2 (INSPIRES2): study protocol for a home-based randomised control trial of digital cognitive behavioural therapy (dCBT) for insomnia. BMJ Open. 2023 Apr 6;13(4):e071764. doi: 10.1136/bmjopen-2023-071764.

  PMID: 37024247 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Melanie K Fleming, Dr

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie K Fleming, Dr

CONTACT

01865 611 461; melanie.fleming@ndcn.ox.ac.uk

Barbara Robinson

CONTACT

sleep-win@ndcn.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Randomisation and facilitation of the intervention will be performed by a research assistant, and the person analysing the data will be blinded to group allocations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomised controlled trial with two parallel study arms: (1) digital cognitive behavioural therapy for insomnia (experimental condition), and (2) treatment as usual (control condition). Randomisation will be using a 2:1 ratio (experimental:control), within minimisation of between group differences in age, sex, baseline Sleep Condition Indicator score and time since stroke.

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: August 22, 2022
• Study Start: September 13, 2022
• Primary Completion: April 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Following publication of results
• Access Criteria: Available upon reasonable request

Locations

GB (1)