StrokeMUSASNCT05867290
Music for Sleep After Stroke
A study testing Mindful music-listening with sleep hygiene in people with Stroke and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cardiovascular Diseases, Brain Diseases
- What is being tested?
- Mindful music-listening with sleep hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Greater Glasgow and Clyde Stroke Services
Glasgow
Jonathan Evans, PhD
About this study
Official title: 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.
- Conditions
- Stroke, Cardiovascular Diseases, Brain Diseases, Vascular Diseases, Insomnia, Sleep Disorder
- Being tested
- Mindful music-listening with sleep hygiene
- Medical subject headings
- Stroke, Cardiovascular Diseases, Brain Diseases, Vascular Diseases, Sleep Initiation and Maintenance Disorders, Sleep Wake Disorders, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful music-listening with sleep hygieneBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| Baseline Phase | No intervention | Randomly allocated baseline phase (no intervention) of 7, 11 or 15 days. |
| Intervention Phase | Experimental | 5 week mindful-music listening intervention including sleep hygiene Receives: Behavioral: Mindful music-listening with sleep hygiene |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Secondary outcomes (11)
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: 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: 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: 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: 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: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Completed daily by the participant during the intervention music listening phase (weeks 3-5 to weeks 8-10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start22 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Single Case Experimental Design (SCED) methodology using multiple baseline across participants.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow, University of Edinburgh
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05867290
- Sponsor's protocol ID
- GN22ST470
- Acronym
- MUSAS
- Status last verified
- May 2023
- First submitted
- 16 Feb 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindful Music-listening to as a Tool to Improve Sleep Post-stroke: A Single Case Experimental Design Study
- ClinicalTrials.gov ID
- NCT05867290
- Acronym / sponsor ID
- MUSAS / GN22ST470
- Conditions
- Stroke, Cardiovascular Diseases, Brain Diseases, Vascular Diseases, Insomnia, Sleep Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow, University of Edinburgh
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Case Experimental Design (SCED) methodology using multiple baseline across participants.
| Arm | Type | Receives |
|---|---|---|
| Baseline Phase | No intervention | –Randomly allocated baseline phase (no intervention) of 7, 11 or 15 days. |
| Intervention Phase | Experimental | Behavioral: Mindful music-listening with sleep hygiene5 week mindful-music listening intervention including sleep hygiene |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindful music-listening with sleep hygiene5 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) | Behavioural | Intervention Phase |
Primary outcome
Sleep onset latency (SOL)
Time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Time taken to fall asleep in minutes measured using actigraphy and a sleep diary completed by the participant. Higher scores indicate greater SOL.
11 secondary outcomes
Total sleep time (TST)
Time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Wake after sleep onset (WASO)
Time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Number of night time awakenings
Time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Time in bed (TIB)
Time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Sleep restoration
Time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).
Insomnia classification
Time frame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
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
Time frame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
Depressive symptoms
Time frame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
Fatigue
Time frame: Completed at baseline, end of intervention (week 1 to weeks 6-8 and at follow up (3 weeks post-intervention)
Adherence
Time frame: Completed daily by the participant during the intervention music listening phase (weeks 3-5 to weeks 8-10)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful music-listening with sleep hygiene in people with Stroke and Cardiovascular Diseases, run by NHS Greater Glasgow and Clyde at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Satu Baylan, PhD (01412113978, s.baylan.1@research.gla.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep onset latency (SOL) (time frame: Measured daily, from baseline to follow-up (day 1 up to day day 71).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.