Clinical trial NCT05867290: Music for Sleep After Stroke
Official title: Mindful Music-listening to as a Tool to Improve Sleep Post-stroke: A Single Case Experimental Design Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Cardiovascular Diseases
Brain Diseases
Vascular Diseases
Insomnia
Sleep Disorder
Sleep Disturbance
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: University of Edinburgh
First posted: 2023-05-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Experimental Design (SCED) methodology using multiple baseline across participants.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sleep onset latency (SOL)
timeFrame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Secondary outcomes:
measure: Total sleep time (TST)
timeFrame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
measure: Wake after sleep onset (WASO)
timeFrame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
measure: Number of night time awakenings
timeFrame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
measure: Time in bed (TIB)
timeFrame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
measure: Sleep restoration
timeFrame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
measure: Insomnia classification
timeFrame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
measure: Daytime sleepiness
timeFrame: Completed at baseline, at the end of intervention (week 1 to weeks 6-8) and at follow-up (3 weeks post-intervention)
measure: Anxiety symptoms
timeFrame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
measure: Depressive symptoms
timeFrame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
measure: Fatigue
timeFrame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
measure: Adherence
timeFrame: Completed daily by the participant during the intervention music listening phase (weeks 3-5 to weeks 8-10)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Greater Glasgow and Clyde Stroke Services
Study officials:
References: