An interventional study of Mindful music-listening with sleep hygiene in Stroke, Cardiovascular Diseases and Brain Diseases, sponsored by NHS Greater Glasgow and Clyde. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-19.
Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 6 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Randomly allocated baseline phase (no intervention) of 7, 11 or 15 days.
5 week mindful-music listening intervention including sleep hygiene
Behavioral: 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)
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.
Time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Completed daily by the participant during the intervention music listening phase (weeks 3-5 to weeks 8-10)
Plan to share: No
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NHS Greater Glasgow and Clyde