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

NCT06580847 | Recruiting

• 1 other identifier: Multisite HL 2024-103
• Study Type: interventional
• Target: 210
• Locations: 5 countries
• Sites: 7

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

Keywords

Hearing loss; speech in noise; psychosocial wellbeing

Outcome Measures

Primary Outcomes (13)

• 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.

  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%).

  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.

  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.

  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.

  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.

  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.

  Baseline and completion (week 0 and week 13)

• Rhythm perception

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

  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.

  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.

  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.

  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".

  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.

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

Other Outcomes (1)

• Heart rate variability and social bonding

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

Study Arms (2)

Group Singing

EXPERIMENTAL

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

Behavioral: Audiobook Club

Audiobook Club

ACTIVE COMPARATOR

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

Behavioral: Group Singing

Interventions

Group Singing BEHAVIORAL

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

Audiobook Club

Audiobook Club BEHAVIORAL

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

Group Singing

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Toronto Metropolitan University: lead
• Memorial University of Newfoundland: collaborator
• University of Groningen: collaborator
• Flinders University: collaborator
• Concordia University, Montreal: collaborator
• University of Southern California: collaborator
• University of Oldenburg: collaborator
• University of Nottingham: collaborator
• The Bionics Institute of Australia: collaborator

Study Sites (7)

Brain and Creativity Institute, University of Southern California

Los Angeles, California, 90089, United States

NOT YET RECRUITING

Flinders University

Adelaide, South Australia, 5042, Australia

NOT YET RECRUITING

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1C 5S7, Canada

NOT YET RECRUITING

Toronto Metropolitan University

Toronto, Ontario, M5B 2K3, Canada

RECRUITING

Concordia University

Montreal, Quebec, H3G 1M8, Canada

NOT YET RECRUITING

Carl von Ossietzky Universitat Oldenburg

Oldenburg, D-26129, Germany

NOT YET RECRUITING

University of Groningen

Groningen, 9700 AB, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 39630812 DERIVED

MeSH Terms

Conditions

Presbycusis; Speech Intelligibility; Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Loss, Sensorineural; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Speech; Verbal Behavior; Communication; Behavior

Study Officials

• Frank Russo, PhD

  Toronto Metropolitan University

  STUDY DIRECTOR

Central Study Contacts

Chi Yhun Lo, PhD

CONTACT

4169795000; chi.lo@torontomu.ca

Kay F Wright-Whyte, MSc

CONTACT

4169795000; kww@torontomu.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 12 week RCT exploring the benefits of group singing and an audiobook club (1.5 hours per week)

Study Record Dates

• First Submitted: August 22, 2024
• First Posted: August 30, 2024
• Study Start: April 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (1); US (1); AU (1); CA (3)