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

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.

Overview

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.

Interventions

• Behavioral Group Singing
  12 week choir program consisting of 1.5 hours of in-person instruction per week.
• Behavioral Audiobook Club
  12 week audiobook club program consisting of 1.5 hours of in-person discussion per week.

Primary outcome measures

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 3 centers

• Memorial University of Newfoundland — St. John's
• Toronto Metropolitan University — Toronto
• Concordia University — Montreal

United States · 1 center

• Brain and Creativity Institute, University of Southern California — Los Angeles

Australia · 1 center

• Flinders University — Adelaide

Germany · 1 center

• Carl von Ossietzky Universitat Oldenburg — Oldenburg

Netherlands · 1 center

• University of Groningen — Groningen

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 controlle PMID 39630812

Identifiers

NCT: NCT06580847 · Multisite HL 2024-103

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗