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Music for Sleep After Stroke (MUSAS)

NHS Trust logo

NHS Trust

Status

Enrolling

Conditions

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

Treatments

Behavioral: Mindful music-listening with sleep hygiene

Study type

Interventional

Funder types

Other

Identifiers

NCT05867290
GN22ST470

Details and patient eligibility

About

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.

Enrollment

6 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 2 patient groups

Baseline Phase
No Intervention group
Description:
Randomly allocated baseline phase (no intervention) of 7, 11 or 15 days.
Intervention Phase
Experimental group
Description:
5 week mindful-music listening intervention including sleep hygiene
Treatment:
Behavioral: Mindful music-listening with sleep hygiene

Trial contacts and locations

1

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Central trial contact

Satu Baylan, PhD; Jonathan Evans, PsyD, PhD

Data sourced from clinicaltrials.gov

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