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NCT Number: NCT06580847

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flinders University, Adelaide, South Australia, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Group singing

Behavioral

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

Audiobook Club

Behavioral

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

Primary outcomes

  1. 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.

  2. 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%).

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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%.

  9. 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.

  10. 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.

  11. 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.

  12. 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".

  13. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chi Yhun Lo, PhD

CONTACT

[email protected]

4169795000 ext. 554989

Kay F Wright-Whyte, MSc

CONTACT

[email protected]

4169795000 ext. 554989

Sponsors and collaborators

Lead sponsor

Toronto Metropolitan University

Other

Collaborators

  • Concordia University, Montreal
  • Flinders University
  • Memorial University of Newfoundland
  • The Bionics Institute of Australia
  • University of Groningen
  • University of Nottingham
  • University of Oldenburg
  • University of Southern California

Registry information

Official study 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.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 30, 2024
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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