Recruiting

Observational Study

Sponsor:

Toronto Metropolitan University

Code:

NCT06580847

Conditions

Hearing Loss, Age-Related

Speech Intelligibility

Psychosocial Functioning

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

Group Singing

Audiobook Club

Study Details

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.

Conditions

Hearing Loss, Age-Related

Speech Intelligibility

Psychosocial Functioning

Study ID

NCT06580847

Start date

Apr 15, 2025

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Group Singing

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

Audiobook Club

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

Primary outcome measure

  • Speech-in-noise perception [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Emotional speech perception [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Quality of Life/Wellness [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Anxiety and Depression [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Self Esteem [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Social Connectedness [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Pitch perception [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Rhythm perception [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Timbre perception [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Higher-level Music perception [ Time Frame: Baseline and completion (week 0 and week 13) ]
  • Positive and Negative Affect [ Time Frame: Pre- and post-session (week 2, 7, 11) ]
  • Anxiety and Discomfort [ Time Frame: Pre- and post-session (week 2, 7, 11) ]
  • Social closeness [ Time Frame: Pre- and post-session (week 2, 7, 11) ]

Central Contacts and Locations

Central contacts

Kay F Wright-Whyte, MSc

4169795000kww@torontomu.ca

Locations

Toronto Metropolitan University

Recruiting

Toronto, Ontario, Canada, M5B 2K3

Contacts

Kay F Wright-Whyte, MSc

4169795000kww@torontomu.ca

More Information

Sponsor

Toronto Metropolitan University

Last update posted

Sep 18, 2025

Last verified

Sep, 2025

Keywords

  • Hearing loss
  • speech in noise
  • psychosocial wellbeing

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Toronto Metropolitan University on 2025-09-18.