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

T

Toronto Metropolitan University

Status

Enrolling

Conditions

Hearing Loss, Age-Related
Speech Intelligibility
Psychosocial Functioning

Treatments

Behavioral: Group Singing
Behavioral: Audiobook Club

Study type

Interventional

Funder types

Other

Identifiers

NCT06580847
Multisite HL 2024-103

Details and patient eligibility

About

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.

Enrollment

210 estimated patients

Sex

All

Ages

60+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

210 participants in 2 patient groups

Group Singing
Experimental group
Description:
12 week group singing program consisting of 1.5 hours of in-person choir instruction per week.
Treatment:
Behavioral: Audiobook Club
Audiobook Club
Active Comparator group
Description:
12 week group program consisting of 1.5 hours of in-person audiobook club discussion per week.
Treatment:
Behavioral: Group Singing

Trial contacts and locations

7

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Central trial contact

Kay F Wright-Whyte, MSc; Chi Yhun Lo, PhD

Data sourced from clinicaltrials.gov

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