Music for Sleep After Stroke

Study Overview
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Brief Summary
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Sleep difficulties are common following stroke yet effective evidence-based interventions for improving sleep in this population are lacking. A small number of studies have investigated the use of music listening as a way to improve sleep in adults with insomnia. 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.

Official Title
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Mindful Music-listening to as a Tool to Improve Sleep Post-stroke: A Single Case Experimental Design Study

Conditions
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Vascular Diseases, Stroke, Cardiovascular Diseases, Brain Diseases, Insomnia, Sleep Disorder, Sleep Disturbance

Intervention / Treatment
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* Behavioral: Mindful music-listening with sleep hygiene


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 18+ (no upper age limit); 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: Transient Ischemic Attack 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single Case Experimental Design (SCED) methodology using multiple baseline across participants.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Baseline Phase<br>Randomly allocated baseline phase (no intervention) of 7, 11 or 15 days. | |
| Experimental: Intervention Phase<br>5 week mindful-music listening intervention including sleep hygiene | Behavioral: Mindful music-listening with sleep hygiene<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep onset latency (SOL) | Time taken to fall asleep in minutes measured using actigraphy and a sleep diary completed by the participant. Higher scores indicate greater SOL. | Measured daily, from baseline to follow-up (day 1 up to day day 71). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total sleep time (TST) | Total time spent asleep in bed in minutes. Measured using actigraphy and a sleep diary completed by the participant. Higher scores indicated longer time spent asleep. | Measured daily, from baseline to follow-up (day 1 up to day day 71). | 
| Wake after sleep onset (WASO) | Total time spent awake after sleep onset in minutes. Measured using actigraphy and a sleep diary completed by the participant. Higher scores indicate longer time spent awake. | Measured daily, from baseline to follow-up (day 1 up to day day 71). | 
| Number of night time awakenings | Total number of awakenings during the night. Measured using actigraphy and a sleep diary completed by the participant. Min = 0 - no Max. Lower scores indicate fewer night time awakenings. | Measured daily, from baseline to follow-up (day 1 up to day day 71). | 
| Time in bed (TIB) | Total time spent in bed in minutes with higher scores indicating longer time spent in bed. Measured using a sleep diary completed by the participant. | Measured daily, from baseline to follow-up (day 1 up to day day 71). | 
| Sleep restoration | Participant rated level of sleep restoration on awakening. Measured using a 3-point scale: refreshed, somewhat refreshed, fatigued. | Measured daily, from baseline to follow-up (day 1 up to day day 71). | 
| Insomnia classification | Sleep Condition Indicator (SCI) score. Min score= 0 - Max= 32 with lower scores indicating poorer sleep. | Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention) | 
| Daytime sleepiness | Epworth Sleepiness Scale (ESS) score. Min score= 0 - Max= 24 with higher scores indicating greater levels of daytime sleepiness. | Completed at baseline, at the end of intervention (week 1 to weeks 6-8) and at follow-up (3 weeks post-intervention) | 
| Anxiety symptoms | Generalized Anxiety Disorder Questionnaire (GAD-7) score. Min= 0 - Max= 21 with higher scores indicating more severe symptoms. | Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention) | 
| Depressive symptoms | Patient Health Questionnaire (PhQ-9) score. Min= 0 - Max= 27 with higher scores indicating more severe symptoms. | Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention) | 
| Fatigue | Fatigue Severity Scale (FSS) score. Min= 9 - Max= 63 with higher scores indicating greater fatigue severity. | Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention) | 
| Adherence | Adherence to mindful music-listening as measured through music listening diary. Min= 0 - Max= 28 with higher scores indicating greater adherence. | Completed daily by the participant during the intervention music listening phase (weeks 3-5 to weeks 8-10) |