Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
6 participants
INTERVENTIONAL
2023-02-22
2023-12-31
Brief Summary
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This study aims to examine whether a mindful music-listening intervention can reduce subjective and objective insomnia symptoms and improve mood and fatigue post-stroke.
Six adults with a clinical diagnosis of stroke presenting with an insomnia disorder will be recruited from stroke services within NHS Greater Glasgow and Clyde. A multiple baseline single case experimental design will be employed. Participants will be randomly allocated to a baseline phase of 7, 11 or 15 days, followed by a five-week mindful music-listening intervention incorporating sleep hygiene. Changes in subjective and objective sleep will be measured using questionnaires and actigraphy, respectively. Mood and fatigue will also be measured. The data will be analysed using visual inspection, Tau-U and multi-level modelling.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Baseline Phase
Randomly allocated baseline phase (no intervention) of 7, 11 or 15 days.
No interventions assigned to this group
Intervention Phase
5 week mindful-music listening intervention including sleep hygiene
Mindful music-listening with sleep hygiene
5 week intervention consisting of sleep hygiene (week 1) and daily bedtime mindful music-listening for 30 minutes or until about to fall asleep, if sooner (weeks 2-5)
Interventions
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Mindful music-listening with sleep hygiene
5 week intervention consisting of sleep hygiene (week 1) and daily bedtime mindful music-listening for 30 minutes or until about to fall asleep, if sooner (weeks 2-5)
Eligibility Criteria
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Inclusion Criteria
* clinically and/or radiologically confirmed diagnosis of stroke
* score of ≤16 on the Sleep Condition Indicator (SCI; (Espie et al, 2018))
* at least 3-months post-stroke
Exclusion Criteria
* subarachnoid hemorrhage
* sleep medication commenced within the last 2 weeks (stable medication accepted)
* significant receptive aphasia or major psychiatric/substance abuse problem preventing engagement in the intervention
* deafness or severe hearing impairment preventing engagement in the intervention (use of hearing aids does not lead to exclusion where these support sufficient level of hearing for engagement)
* unable to give informed consent.
* participation in another intervention study with risk of contamination of study outcomes (determined on a case-by-case basis)
18 Years
ALL
No
Sponsors
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University of Glasgow
OTHER
University of Edinburgh
OTHER
NHS Greater Glasgow and Clyde
OTHER
Responsible Party
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Locations
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Greater Glasgow and Clyde Stroke Services
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Jonathan Evans, PhD
Role: primary
Other Identifiers
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GN22ST470
Identifier Type: -
Identifier Source: org_study_id
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