Ignite Creation Date:
2024-05-06 @ 7:01 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05867290
Status:
RECRUITING
Last Update Posted:
2023-05-19
First Post:
2023-02-16
Brief Title:
Music for Sleep After Stroke
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
Mindful Music-listening to as a Tool to Improve Sleep Post-stroke A Single Case Experimental Design Study
Status:
RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MUSAS
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None