ClinicalTrials.gg
RecruitingNCT06580847Updated Sep 18, 2025

Benefits of Choir for Older Adults With Unaddressed Hearing Loss (WP2)

An interventional study of Group Singing and Audiobook Club in Hearing Loss, Age-Related, Speech Intelligibility and Psychosocial Functioning, sponsored by Toronto Metropolitan University. Recruiting at 7 sites in 5 countries. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-09-18.

Sponsored by Toronto Metropolitan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2025; still recruiting 1 year 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
210
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Hearing Loss, Age-Related
  • Speech Intelligibility
  • Psychosocial Functioning

Keywords

  • Hearing loss
  • speech in noise
  • psychosocial wellbeing
03

In context

Presbycusis

66 studies on the registry are indexed under Presbycusis; 21 are open to participants now.

This study's planned enrollment of 210 is above the median of 60 across 45 interventional studies indexed under Presbycusis.

Browse Presbycusis studies →

Lead sponsor

Toronto Metropolitan University is the lead sponsor of 63 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
210 participants (estimated)

Study arms

  • Experimental
    Group Singing

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

    Behavioral: Audiobook Club

  • Active comparator
    Audiobook Club

    12 week group program consisting of 1.5 hours of in-person audiobook club discussion per week.

    Behavioral: Group Singing

Interventions

  • BehavioralGroup Singing

    12 week choir program consisting of 1.5 hours of in-person instruction per week.

  • BehavioralAudiobook Club

    12 week audiobook club program consisting of 1.5 hours of in-person discussion per week.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and completion (week 0 and week 13)

  2. Emotional speech perception

    The EmoHI is calculated as the mean accuracy of correct responses as a percentage (0 to 100%).

    Time frame: Baseline and completion (week 0 and week 13)

  3. 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.

    Time frame: Baseline and completion (week 0 and week 13)

  4. 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.

    Time frame: Baseline and completion (week 0 and week 13)

  5. 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.

    Time frame: Baseline and completion (week 0 and week 13)

  6. 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.

    Time frame: Baseline and completion (week 0 and week 13)

  7. Pitch perception

    The Frequency Difference Limen (FDL) task evaluates pitch perception threshold. A lower threshold indicates better pitch perception abilities.

    Time frame: Baseline and completion (week 0 and week 13)

  8. Rhythm perception

    The Beat Alignment Test (BAT) measures rhythm perception accuracy between 0 and 100%.

    Time frame: Baseline and completion (week 0 and week 13)

  9. 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.

    Time frame: Baseline and completion (week 0 and week 13)

  10. 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.

    Time frame: Baseline and completion (week 0 and week 13)

  11. 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.

    Time frame: Pre- and post-session (week 2, 7, 11)

  12. 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".

    Time frame: Pre- and post-session (week 2, 7, 11)

  13. 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.

    Time frame: Pre- and post-session (week 2, 7, 11)

Other outcomes

  1. Heart rate variability and social bonding

    Heart rate variability (HRV) is a proxy measure of social bonding. Higher HRV is anticipated to be associated with higher levels of social bonding.

    Time frame: Pre- and post-session (week 2, 7, 11)

07

Study locations

2 of 7 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2025 (actual). Primary completion is estimated for Sep 2026, 17 months after the start.

Of 25 interventional studies with no phase under Presbycusis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 58. This study's planned 17 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 22, 2024
First posted
Aug 30, 2024
StartActual
Apr 15, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Sep 2026
Last update
Sep 18, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06580847
Lead sponsor
Toronto Metropolitan University
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
Frank Russo (Principal Investigator, Toronto Metropolitan University) — Principal investigator
First posted
Aug 30, 2024
Start date
Apr 15, 2025
Primary completion
Sep 2026 (estimated)
Completion
Sep 2026 (estimated)
Last update
Sep 18, 2025

Study contacts

Chi Yhun Lo, PhD
Contact
chi.lo@torontomu.ca
4169795000 ext. 554989
Kay F Wright-Whyte, MSc
Contact
kww@torontomu.ca
4169795000 ext. 554989
Frank Russo, PhD
study director · Toronto Metropolitan University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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