Hearing Loss, Age-RelatedNCT06580847
Benefits of Choir for Older Adults With Unaddressed Hearing Loss (WP2)
A study testing Group Singing and Audiobook Club in people with Hearing Loss, Age-Related and Speech Intelligibility, run by Toronto Metropolitan University at 7 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hearing Loss, Age-Related, Speech Intelligibility, Psychosocial Functioning
- What is being tested?
- Group Singing and Audiobook Club
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 15 Apr 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
7 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 5 countries
Canada3 sites, 3 recruiting
- Not yet recruiting
Concordia University
Montreal, Quebec, H3G 1M8
Emily Coffey, emily.coffey@concordia.ca
Nathan Gagne, nathan.gagne@mail.concordia.ca
- Not yet recruiting
Memorial University of Newfoundland
St. John's, Newfoundland and Labrador, A1C 5S7
Benjamin R Zendel, PhD, bzendel@mun.ca
- Recruiting
Toronto Metropolitan University
Toronto, Ontario, M5B 2K3
Chi Yhun Lo, PhD, 4169795000 ext. 554989, chi.lo@torontomu.ca
Kay F Wright-Whyte, MSc, 4169795000 ext. 554989, kww@torontomu.ca
United States1 site, 1 recruiting
- Not yet recruiting
Brain and Creativity Institute, University of Southern California
Los Angeles, California, 90089
Assal Habibi, ahbibi@usc.edu
Australia1 site, 1 recruiting
- Not yet recruiting
Flinders University
Adelaide, South Australia, 5042
Mridula Sharma, mridula.sharma@flinders.edu.au
Christian Boyle, boyl0109@flinders.edu.au
Germany1 site, 1 recruiting
- Not yet recruiting
Carl von Ossietzky Universitat Oldenburg
Oldenburg, D-26129
Gunter Kreutz, gunter.kreutz@uni-oldenburg.de
Eva Schurig, eva.schurig@uni-oldenburg.edu
Netherlands1 site, 1 recruiting
- Recruiting
University of Groningen
Groningen, 9700 AB
Deniz Baskent, d.baskent@rug.nl
Ellie Harding, e.e.harding@rug.nl
About this study
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.
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.
Read more
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.
- Being tested
- Group Singing, Audiobook Club
- Keywords
- Hearing loss, speech in noise, psychosocial wellbeing
- Medical subject headings
- Presbycusis, Speech Intelligibility, Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group SingingBehavioural
12 week choir program consisting of 1.5 hours of in-person instruction per week.
Audiobook ClubBehavioural
12 week audiobook club program consisting of 1.5 hours of in-person discussion per week.
| Study group | Role | What they receive |
|---|---|---|
| Group Singing | Experimental | 12 week group singing program consisting of 1.5 hours of in-person choir instruction per week. Receives: Behavioral: Audiobook Club |
| Audiobook Club | Active comparator | 12 week group program consisting of 1.5 hours of in-person audiobook club discussion per week. Receives: Behavioral: Group Singing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Speech-in-noise perception
The Coordinate Response Matrix (CRM) generates signal-to-noise ratio (SNR). A lower SNR is indicative of better speech-in-noise perception.
Measured: Baseline and completion (week 0 and week 13)
Emotional speech perception
The EmoHI is calculated as the mean accuracy of correct responses as a percentage (0 to 100%).
Measured: Baseline and completion (week 0 and week 13)
Quality of Life/Wellness
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.
Measured: Baseline and completion (week 0 and week 13)
Anxiety and Depression
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.
Measured: Baseline and completion (week 0 and week 13)
Self Esteem
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.
Measured: Baseline and completion (week 0 and week 13)
Social Connectedness
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.
Measured: Baseline and completion (week 0 and week 13)
Pitch perception
The Frequency Difference Limen (FDL) task evaluates pitch perception threshold. A lower threshold indicates better pitch perception abilities.
Measured: Baseline and completion (week 0 and week 13)
Rhythm perception
The Beat Alignment Test (BAT) measures rhythm perception accuracy between 0 and 100%.
Measured: Baseline and completion (week 0 and week 13)
Timbre perception
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.
Measured: Baseline and completion (week 0 and week 13)
Higher-level Music perception
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.
Measured: Baseline and completion (week 0 and week 13)
Positive and Negative Affect
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.
Measured: Pre- and post-session (week 2, 7, 11)
Anxiety and Discomfort
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".
Measured: Pre- and post-session (week 2, 7, 11)
Social closeness
The Inclusion of Other in the Self Scale (IOS) is scored between 1 and 7, with a higher score representing more social closeness.
Measured: Pre- and post-session (week 2, 7, 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start15 Apr 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hearing Loss, Age-RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12 week RCT exploring the benefits of group singing and an audiobook club (1.5 hours per week)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial University of Newfoundland, University of Groningen, Flinders University, Concordia University, Montreal, University of Southern California, University of Oldenburg, University of Nottingham, The Bionics Institute of Australia
- Responsible party
- Principal investigator, Frank Russo, Toronto Metropolitan University
- Investigators
- Frank Russo, PhD, Study director, Toronto Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580847
- Sponsor's protocol ID
- Multisite HL 2024-103
- Status last verified
- Sep 2025
- First submitted
- 22 Aug 2024
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lo CY, Zendel BR, Baskent D, Boyle C, Coffey E, Gagne N, Habibi A, Harding E, Keijzer M, Kreutz G, Maat B, Schurig E, Sharma M, Dang C, Gilmore S, Henshaw H, McKay CM, Good A, Russo FA. 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, registered report protocol. PLoS One. 2024 Dec 4;19(12):e0314473. doi: 10.1371/journal.pone.0314473. eCollection 2024.
PubMed 39630812
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06580847
- Acronym / sponsor ID
- Multisite HL 2024-103
- Keywords
- Hearing loss, speech in noise, psychosocial wellbeing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Toronto Metropolitan UniversityUniversity, hospital or other
- Collaborators
- Memorial University of Newfoundland, University of Groningen, Flinders University, Concordia University, Montreal, University of Southern California, University of Oldenburg, University of Nottingham, The Bionics Institute of Australia
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 12 week RCT exploring the benefits of group singing and an audiobook club (1.5 hours per week)
| Arm | Type | Receives |
|---|---|---|
| Group Singing | Experimental | Behavioral: Audiobook Club12 week group singing program consisting of 1.5 hours of in-person choir instruction per week. |
| Audiobook Club | Active comparator | Behavioral: Group Singing12 week group program consisting of 1.5 hours of in-person audiobook club discussion per week. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group Singing12 week choir program consisting of 1.5 hours of in-person instruction per week. | Behavioural | Audiobook Club |
| Audiobook Club12 week audiobook club program consisting of 1.5 hours of in-person discussion per week. | Behavioural | Group Singing |
Primary outcome
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.
Emotional speech perception
Time frame: Baseline and completion (week 0 and week 13)
The EmoHI is calculated as the mean accuracy of correct responses as a percentage (0 to 100%).
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.
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.
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.
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.
Pitch perception
Time frame: Baseline and completion (week 0 and week 13)
The Frequency Difference Limen (FDL) task evaluates pitch perception threshold. A lower threshold indicates better pitch perception abilities.
Rhythm perception
Time frame: Baseline and completion (week 0 and week 13)
The Beat Alignment Test (BAT) measures rhythm perception accuracy between 0 and 100%.
Timbre perception
Time frame: Baseline and completion (week 0 and week 13)
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.
Higher-level Music perception
Time frame: Baseline and completion (week 0 and week 13)
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.
Positive and Negative Affect
Time frame: Pre- and post-session (week 2, 7, 11)
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.
Anxiety and Discomfort
Time frame: Pre- and post-session (week 2, 7, 11)
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".
Social closeness
Time frame: Pre- and post-session (week 2, 7, 11)
The Inclusion of Other in the Self Scale (IOS) is scored between 1 and 7, with a higher score representing more social closeness.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 39630812Lo CY, Zendel BR, Baskent D, Boyle C, Coffey E, Gagne N, Habibi A, Harding E, Keijzer M, Kreutz G, Maat B, Schurig E, Sharma M, Dang C, Gilmore S, Henshaw H, McKay CM, Good A, Russo FA. 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, registered report protocol. PLoS One. 2024 Dec 4;19(12):e0314473. doi: 10.1371/journal.pone.0314473. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frank Russo, PhD study director
Toronto Metropolitan University
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Singing and Audiobook Club in people with Hearing Loss, Age-Related and Speech Intelligibility, run by Toronto Metropolitan University at 7 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada, United States, Australia, Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Yhun Lo, PhD (4169795000 ext. 554989, chi.lo@torontomu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Speech-in-noise perception (time frame: Baseline and completion (week 0 and week 13)). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06580847, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.