Music for Sleep After Stroke

NCT05867290 | Unknown

• 1 other identifier: GN22ST470
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Total sleep time (TST)

  Measured daily, from baseline to follow-up (day 1 up to day day 71).

• Wake after sleep onset (WASO)

  Measured daily, from baseline to follow-up (day 1 up to day day 71).

• Number of night time awakenings

  Measured daily, from baseline to follow-up (day 1 up to day day 71).

• Time in bed (TIB)

  Measured daily, from baseline to follow-up (day 1 up to day day 71).

• Sleep restoration

  Measured daily, from baseline to follow-up (day 1 up to day day 71).

Study Arms (2)

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

Behavioral: Mindful music-listening with sleep hygiene

Interventions

Mindful music-listening with sleep hygiene BEHAVIORAL

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)

Intervention Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• unable to give informed consent.
• participation in another intervention study with risk of contamination of study outcomes (determined on a case-by-case basis)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator
• University of Edinburgh: collaborator

Study Sites (1)

Greater Glasgow and Clyde Stroke Services

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke; Cardiovascular Diseases; Brain Diseases; Vascular Diseases; Sleep Initiation and Maintenance Disorders; Sleep Wake Disorders; Parasomnias

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Central Nervous System Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Satu Baylan, PhD

CONTACT

01412113978; s.baylan.1@research.gla.ac.uk

Jonathan Evans, PsyD, PhD

CONTACT

01412113978; jonathan.evans@gla.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Case Experimental Design (SCED) methodology using multiple baseline across participants.

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: May 19, 2023
• Study Start: February 22, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)