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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06580847




Registration number
NCT06580847
Ethics application status
Date submitted
22/08/2024
Date registered
30/08/2024
Date last updated
30/08/2024

Titles & IDs
Public title
Benefits of Choir for Older Adults with Unaddressed Hearing Loss (WP2)
Scientific 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.
Secondary ID [1] 0 0
Multisite HL 2024-103
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hearing Loss, Age-Related 0 0
Speech Intelligibility 0 0
Psychosocial Functioning 0 0
Condition category
Condition code
Ear 0 0 0 0
Deafness
Ear 0 0 0 0
Other ear disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
BEHAVIORAL - Group Singing
BEHAVIORAL - Audiobook Club

Experimental: Group Singing - 12 week group singing program consisting of 1.5 hours of in-person choir instruction per week.

Active comparator: Audiobook Club - 12 week group program consisting of 1.5 hours of in-person audiobook club discussion per week.


BEHAVIORAL: Group Singing
12 week choir program consisting of 1.5 hours of in-person instruction per week.

BEHAVIORAL: Audiobook Club
12 week audiobook club program consisting of 1.5 hours of in-person discussion per week.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Speech-in-noise perception
Timepoint [1] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [2] 0 0
Emotional speech perception
Timepoint [2] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [3] 0 0
Quality of Life/Wellness
Timepoint [3] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [4] 0 0
Anxiety and Depression
Timepoint [4] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [5] 0 0
Self Esteem
Timepoint [5] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [6] 0 0
Social Connectedness
Timepoint [6] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [7] 0 0
Pitch perception
Timepoint [7] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [8] 0 0
Rhythm perception
Timepoint [8] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [9] 0 0
Timbre perception
Timepoint [9] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [10] 0 0
Higher-level Music perception
Timepoint [10] 0 0
Baseline and completion (week 0 and week 13)
Primary outcome [11] 0 0
Positive and Negative Affect
Timepoint [11] 0 0
Pre- and post-session (week 2, 7, 11)
Primary outcome [12] 0 0
Anxiety and Discomfort
Timepoint [12] 0 0
Pre- and post-session (week 2, 7, 11)
Primary outcome [13] 0 0
Social closeness
Timepoint [13] 0 0
Pre- and post-session (week 2, 7, 11)

Eligibility
Key inclusion criteria
1. Adults aged 60 years and older;
2. Bilateral mild-to-moderate hearing loss (20-49 dB hearing level), measured using four-frequency pure-tone average across both ears (4FPTA) measured at 500 Hz, 1000 Hz, 2000 Hz, and 4000 Hz;
3. Unaddressed hearing loss (i.e., participants must not currently use a hearing aid, cochlear implant, or assistive listening device);
4. No significant cognitive impairment, to be assessed with the Montreal Cognitive Assessment for people with hearing impairment (MoCA-H), with participants requiring a score = 24;
5. Not use a pacemaker or anti-arrhythmic agents/medications;
6. Not currently participating in regular active music learning (e.g., choir, formal music training) or audiobook clubs within the last year; and
7. Sufficient language capacity to understand and complete the test materials. Note: all materials will be presented written and/or aurally in English at the sites located in Canada, United States of America, and Australia; Dutch at the Netherlands site; and German at the Germany site.
Minimum age
60 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/09/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
Flinders University - Adelaide
Recruitment postcode(s) [1] 0 0
5042 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
Canada
State/province [2] 0 0
Newfoundland and Labrador
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
Canada
State/province [4] 0 0
Quebec
Country [5] 0 0
Germany
State/province [5] 0 0
Oldenburg
Country [6] 0 0
Netherlands
State/province [6] 0 0
Groningen

Funding & Sponsors
Primary sponsor type
Other
Name
Toronto Metropolitan University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Memorial University of Newfoundland
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Groningen
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Flinders University
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Concordia University, Montreal
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
University of Southern California
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of Oldenburg
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
University of Nottingham
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
Bionics Institute
Address [8] 0 0
Country [8] 0 0

Ethics approval
Ethics application status

Summary
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 (i.e., pre- and post-measures across the 12-weeks), or micro timepoints (i.e., 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.
Trial website
https://clinicaltrials.gov/study/NCT06580847
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Frank Russo, PhD
Address 0 0
Toronto Metropolitan University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chi Yhun Lo, PhD
Address 0 0
Country 0 0
Phone 0 0
4169795000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06580847