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Improving Sleep in Rehabilitation After Stroke (INSPIRES)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04272892
Recruitment Status : Recruiting
First Posted : February 17, 2020
Last Update Posted : February 19, 2020
Sponsor:
Collaborator:
Big Health
Information provided by (Responsible Party):
University of Oxford

Brief 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.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Digital cognitive behavioural therapy for insomnia Behavioral: Sleep hygiene information Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomised (1:1 ratio) to the intervention or control group, using a computer generated minimisation method, with minimisation of between groups differences in age and baseline self-reported sleep quality (sleep condition indicator score)
Masking: Single (Participant)
Masking Description: Participants will be told that they will be assigned to one of two groups but will not be told whether one is hypothesised to be superior over another
Primary Purpose: Treatment
Official Title: An Investigation Into the Efficacy of Online Cognitive Behavioural Therapy for Insomnia ("Sleepio") to Improve Sleep After Stroke.
Actual Study Start Date : February 14, 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

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 Name: 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




Primary Outcome Measures :
  1. Change in Sleep Condition Indicator score [ Time Frame: 8 weeks ]
    Self-reported sleep quality questionnaire, range 0-32, higher numbers indicate better sleep quality


Secondary Outcome Measures :
  1. Maintenance of change in Sleep Condition Indicator score [ Time Frame: 16 weeks ]
    Self-reported sleep quality questionnaire, range 0-32, higher scores indicate better sleep quality

  2. Change in sleep fragmentation [ Time Frame: 8 weeks ]
    Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep

  3. Maintenance of change in sleep fragmentation [ Time Frame: 16 weeks ]
    Sleep fragmentation assessed using actigraphy, higher values indicate more disrupted sleep

  4. Change in wake after sleep onset [ Time Frame: 8 weeks ]
    Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep

  5. Maintenance of change in wake after sleep onset [ Time Frame: 16 weeks ]
    Wake after sleep onset assessed using actigraphy, higher values indicate more disrupted sleep

  6. Change in sleep onset latency [ Time Frame: 8 weeks ]
    Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality

  7. Maintenance of change in sleep onset latency [ Time Frame: 16 weeks ]
    Sleep onset latency assessed using online sleep diary, higher values indicate poorer sleep quality

  8. Change in self-reported depression [ Time Frame: 8 weeks ]
    Change in PHQ9, range 0-20, higher values indicate more depressive symptoms

  9. Maintenance of change in self-reported depression [ Time Frame: 16 weeks ]
    Change in PHQ9, range 0-20, higher values indicate more depressive symptoms

  10. Change in self-reported anxiety [ Time Frame: 8 weeks ]
    Change in GAD7, range 0-21, higher values indicate more anxiety symptoms

  11. Maintenance of change in self-reported anxiety [ Time Frame: 16 weeks ]
    Change in GAD7, range 0-21, higher values indicate more anxiety symptoms

  12. Change in stroke specific quality of life [ Time Frame: 8 weeks ]
    Change in SIS-8, range 0-40, higher values less impact of stroke on quality of life

  13. Maintenance of change in stroke specific quality of life [ Time Frame: 16 weeks ]
    Change in SIS-8, range 0-40, higher values indicate less impact of stroke on quality of life


Other Outcome Measures:
  1. Cost effectiveness [ Time Frame: 16 weeks ]
    Assessed as incremental cost effectiveness ratio, using EQ-5D-5L, range 0-5 for each dimension, higher values indicate more problems



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04272892


Contacts
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Contact: Melanie K Fleming, PhD +441865611461 melanie.fleming@ndcn.ox.ac.uk
Contact: Heidi Johansen-Berg, PhD heidi.johansen-berg@ndcn.ox.ac.uk

Locations
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United Kingdom
Wellcome Centre for Integrative Neuroimaging (WIN) Recruiting
Oxford, United Kingdom, OX3 9DU
Contact: Melanie K Fleming, PhD    +441865611461    melanie.fleming@ndcn.ox.ac.uk   
Contact: Heidi Johansen-Berg, PhD    +441865610469    heidi.johasen-berg@ndcn.ox.ac.uk   
Sponsors and Collaborators
University of Oxford
Big Health
Investigators
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Principal Investigator: Heidi Johansen-Berg, PhD University of Oxford, UK

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT04272892    
Other Study ID Numbers: INSPIRES
First Posted: February 17, 2020    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data are available upon reasonable request
Supporting Materials: Study Protocol
Time Frame: Following publication of results
Access Criteria: Available upon reasonable request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oxford:
Sleep
Rehabilitation
Digital
Cognitive Behavioural Therapy for Insomnia
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases