Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06580847
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-22
Brief Title:
Benefits of Choir for Older Adults with Unaddressed Hearing Loss WP2
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Speech-in-noise Psychosocial and Heart Rate Variability Outcomes of Group Singing or Audiobook Club Interventions for Older Adults with Unaddressed Hearing Loss a SingWell Project Multisite Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Unaddressed age-related hearing loss is highly prevalent among older adults typified by negative consequences for speech-in-noise perception and psychosocial wellbeing There is promising evidence that group singing may enhance speech-in-noise perception and psychosocial wellbeing However there is a lack of robust evidence primarily due to the literature being based on small sample sizes single site studies and a lack of randomized controlled trials Hence to address these concerns this SingWell Project study utilizes an appropriate sample size multisite randomized controlled trial approach with a robust preplanned statistical analysis
The objective of the study is to explore if group singing may improve speech-in-noise perception and psychosocial wellbeing for older adults with unaddressed hearing loss
The investigators designed an international multisite randomized controlled trial to explore the benefits of group singing for adults aged 60 years and older with unaddressed hearing loss After undergoing an eligibility screening process and completing an information and consent form the investigators intend to recruit 210 participants that will be randomly assigned to either group singing or an audiobook club control group intervention for a training period of 12-weeks The study has multiple timepoints for testing that are broadly categorized as macro ie pre- and post-measures across the 12-weeks or micro timepoints ie pre- and post-measures across a weekly training session Macro measures include behavioural measures of speech and music perception and psychosocial questionnaires Micro measures include psychosocial questionnaires and heart-rate variability
The investigators hypothesize that group singing may be effective at improving speech perception and psychosocial outcomes for older adults with unaddressed hearing loss-more so than participants in the control group
The objective of the study is to explore if group singing may improve speech-in-noise perception and psychosocial wellbeing for older adults with unaddressed hearing loss
The investigators designed an international multisite randomized controlled trial to explore the benefits of group singing for adults aged 60 years and older with unaddressed hearing loss After undergoing an eligibility screening process and completing an information and consent form the investigators intend to recruit 210 participants that will be randomly assigned to either group singing or an audiobook club control group intervention for a training period of 12-weeks The study has multiple timepoints for testing that are broadly categorized as macro ie pre- and post-measures across the 12-weeks or micro timepoints ie pre- and post-measures across a weekly training session Macro measures include behavioural measures of speech and music perception and psychosocial questionnaires Micro measures include psychosocial questionnaires and heart-rate variability
The investigators hypothesize that group singing may be effective at improving speech perception and psychosocial outcomes for older adults with unaddressed hearing loss-more so than participants in the control group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None