- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06580847
Benefits of Choir for Older Adults With Unaddressed Hearing Loss (WP2)
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Chi Yhun Lo, PhD
- Phone Number: 554989 4169795000
- Email: chi.lo@torontomu.ca
Study Contact Backup
- Name: Kay F Wright-Whyte, MSc
- Phone Number: 554989 4169795000
- Email: kww@torontomu.ca
Study Locations
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South Australia
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Adelaide, South Australia, Australia, 5042
- Not yet recruiting
- Flinders University
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Contact:
- Mridula Sharma
- Email: mridula.sharma@flinders.edu.au
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Contact:
- Christian Boyle
- Email: boyl0109@flinders.edu.au
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Newfoundland and Labrador
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St. John's, Newfoundland and Labrador, Canada, A1C 5S7
- Not yet recruiting
- Memorial University of Newfoundland
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Contact:
- Benjamin R Zendel, PhD
- Email: bzendel@mun.ca
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Ontario
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Toronto, Ontario, Canada, M5B 2K3
- Recruiting
- Toronto Metropolitan University
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Contact:
- Chi Yhun Lo, PhD
- Phone Number: 554989 4169795000
- Email: chi.lo@torontomu.ca
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Contact:
- Kay F Wright-Whyte, MSc
- Phone Number: 554989 4169795000
- Email: kww@torontomu.ca
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Quebec
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Montreal, Quebec, Canada, H3G 1M8
- Not yet recruiting
- Concordia University
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Contact:
- Emily Coffey
- Email: emily.coffey@concordia.ca
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Contact:
- Nathan Gagne
- Email: nathan.gagne@mail.concordia.ca
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Oldenburg, Germany, D-26129
- Not yet recruiting
- Carl von Ossietzky Universitat Oldenburg
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Contact:
- Gunter Kreutz
- Email: gunter.kreutz@uni-oldenburg.de
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Contact:
- Eva Schurig
- Email: eva.schurig@uni-oldenburg.edu
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Groningen, Netherlands, 9700 AB
- Recruiting
- University of Groningen
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Contact:
- Deniz Baskent
- Email: d.baskent@rug.nl
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Contact:
- Ellie Harding
- Email: e.e.harding@rug.nl
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California
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Los Angeles, California, United States, 90089
- Not yet recruiting
- Brain and Creativity Institute, University of Southern California
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Contact:
- Assal Habibi
- Email: ahbibi@usc.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 60 years and older;
- 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;
- Unaddressed hearing loss (i.e., participants must not currently use a hearing aid, cochlear implant, or assistive listening device);
- 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;
- Not use a pacemaker or anti-arrhythmic agents/medications;
- Not currently participating in regular active music learning (e.g., choir, formal music training) or audiobook clubs within the last year; and
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group Singing
12 week group singing program consisting of 1.5 hours of in-person choir instruction per week.
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12 week audiobook club program consisting of 1.5 hours of in-person discussion per week.
|
|
Active Comparator: Audiobook Club
12 week group program consisting of 1.5 hours of in-person audiobook club discussion per week.
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12 week choir program consisting of 1.5 hours of in-person instruction per week.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Speech-in-noise perception
Time Frame: Baseline and completion (week 0 and week 13)
|
The Coordinate Response Matrix (CRM) generates signal-to-noise ratio (SNR).
A lower SNR is indicative of better speech-in-noise perception.
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Baseline and completion (week 0 and week 13)
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Emotional speech perception
Time Frame: Baseline and completion (week 0 and week 13)
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The EmoHI is calculated as the mean accuracy of correct responses as a percentage (0 to 100%).
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Baseline and completion (week 0 and week 13)
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Quality of Life/Wellness
Time Frame: Baseline and completion (week 0 and week 13)
|
The 12-item short-form survey version 2 (SF-12v2) from the Medical Outcomes Study (MOS) generates a Physical Summary and a Mental Summary of patient quality of life.
Scores range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
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Baseline and completion (week 0 and week 13)
|
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Anxiety and Depression
Time Frame: Baseline and completion (week 0 and week 13)
|
The Hospital Anxiety and Depression Scale (HADS) provides a score between 0 and 21, with higher scores indicative of higher levels of anxiety or depression.
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Baseline and completion (week 0 and week 13)
|
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Self Esteem
Time Frame: Baseline and completion (week 0 and week 13)
|
The Collective Self-Esteem Scale (CSES) consists of four scales: Membership self-esteem, Private collective self-esteem, Public collective self-esteem, and Importance to Identity.
Each scale is scored between 1 and 7, with a higher score indicating high levels of self-esteem.
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Baseline and completion (week 0 and week 13)
|
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Social Connectedness
Time Frame: Baseline and completion (week 0 and week 13)
|
The revised Social Connectedness Scale (SCS-R) is scored as a total between 8 and 48 points, with higher scores indicating higher levels of social connectedness.
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Baseline and completion (week 0 and week 13)
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Pitch perception
Time Frame: Baseline and completion (week 0 and week 13)
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The Frequency Difference Limen (FDL) task evaluates pitch perception threshold.
A lower threshold indicates better pitch perception abilities.
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Baseline and completion (week 0 and week 13)
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Rhythm perception
Time Frame: Baseline and completion (week 0 and week 13)
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The Beat Alignment Test (BAT) measures rhythm perception accuracy between 0 and 100%.
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Baseline and completion (week 0 and week 13)
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Timbre perception
Time Frame: Baseline and completion (week 0 and week 13)
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The Spectral-temporally Modulated Ripple Test (SMRT) is a proxy measure of timbre perception.
It generates a threshold based on performance.
A higher ripple-per-octave threshold is indicative of better spectro-temporal (timbre) perception.
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Baseline and completion (week 0 and week 13)
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Higher-level Music perception
Time Frame: Baseline and completion (week 0 and week 13)
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The Music-in-Noise Task (MINT) is an auditory stream segregation task that is a proxy measure of higher-level music perception.
It is scored as proportion correct between 0 and 1.
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Baseline and completion (week 0 and week 13)
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Positive and Negative Affect
Time Frame: Pre- and post-session (week 2, 7, 11)
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The Positive and Negative Affect Schedule (PANAS) consists of a positive and negative outcome measure; each ranging between 10 and 50.
For the positive scale, a higher score represents higher levels of positive affect.
One the negative scale, a lower score represents lower levels of negative affect.
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Pre- and post-session (week 2, 7, 11)
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Anxiety and Discomfort
Time Frame: Pre- and post-session (week 2, 7, 11)
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The Subjective Units of Discomfort Scale (SUDS) is scored between 0 and 100, with descriptive anchor points.
0 = "no anxiety, calm, relaxed"; 25 = "mild anxiety, alert, able to cope"; 50 = "moderate anxiety, some trouble concentrating"; 75 = "severe anxiety, thoughts of leaving"; and 100 = "very severe anxiety, worst ever experienced".
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Pre- and post-session (week 2, 7, 11)
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Social closeness
Time Frame: Pre- and post-session (week 2, 7, 11)
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The Inclusion of Other in the Self Scale (IOS) is scored between 1 and 7, with a higher score representing more social closeness.
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Pre- and post-session (week 2, 7, 11)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart rate variability and social bonding
Time Frame: Pre- and post-session (week 2, 7, 11)
|
Heart rate variability (HRV) is a proxy measure of social bonding.
Higher HRV is anticipated to be associated with higher levels of social bonding.
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Pre- and post-session (week 2, 7, 11)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Frank Russo, PhD, Toronto Metropolitan University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Otorhinolaryngologic Diseases
- Sensation Disorders
- Ear Diseases
- Hearing Disorders
- Hearing Loss, Sensorineural
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Communication
- Verbal Behavior
- Speech
- Hearing Loss
- Presbycusis
- Speech Intelligibility
Other Study ID Numbers
- Multisite HL 2024-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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