Music for Sleep After Stroke (MUSAS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Vascular Diseases; Stroke; Brain Diseases; Sleep Disorder; Insomnia; Sleep Disturbance
• Intervention / Treatment: Behavioral: Mindful music-listening with sleep hygiene

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Satu Baylan, PhD; Phone Number: 01412113978; Email: s.baylan.1@research.gla.ac.uk
• Study Contact Backup: Name: Jonathan Evans, PsyD, PhD; Phone Number: 01412113978; Email: jonathan.evans@gla.ac.uk

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • Recruiting
    • Greater Glasgow and Clyde Stroke Services
    • Contact: Jonathan Evans, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline Phase; Randomly allocated baseline phase (no intervention) of 7, 11 or 15 days.
Experimental: Intervention Phase; 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)

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: NHS Greater Glasgow and Clyde
• Collaborators: University of Edinburgh; University of Glasgow

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2023
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: February 16, 2023
• First Submitted That Met QC Criteria: May 17, 2023
• First Posted (Actual): May 19, 2023

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: May 17, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Stroke; Cardiovascular Diseases; Vascular Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias; Brain Diseases
• Other Study ID Numbers: GN22ST470

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No