Clinical trial NCT06580847: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss, Age-Related
Speech Intelligibility
Psychosocial Functioning
Keywords: Hearing loss
speech in noise
psychosocial wellbeing
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Memorial University of Newfoundland
name: University of Groningen
name: Flinders University
name: Concordia University, Montreal
name: University of Southern California
name: University of Oldenburg
name: University of Nottingham
name: The Bionics Institute of Australia
First posted: 2024-08-30
Enrollment: 210
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 12 week RCT exploring the benefits of group singing and an audiobook club (1.5 hours per week)
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Speech-in-noise perception
timeFrame: Baseline and completion (week 0 and week 13)
measure: Emotional speech perception
timeFrame: Baseline and completion (week 0 and week 13)
measure: Quality of Life/Wellness
timeFrame: Baseline and completion (week 0 and week 13)
measure: Anxiety and Depression
timeFrame: Baseline and completion (week 0 and week 13)
measure: Self Esteem
timeFrame: Baseline and completion (week 0 and week 13)
measure: Social Connectedness
timeFrame: Baseline and completion (week 0 and week 13)
measure: Pitch perception
timeFrame: Baseline and completion (week 0 and week 13)
measure: Rhythm perception
timeFrame: Baseline and completion (week 0 and week 13)
measure: Timbre perception
timeFrame: Baseline and completion (week 0 and week 13)
measure: Higher-level Music perception
timeFrame: Baseline and completion (week 0 and week 13)
measure: Positive and Negative Affect
timeFrame: Pre- and post-session (week 2, 7, 11)
measure: Anxiety and Discomfort
timeFrame: Pre- and post-session (week 2, 7, 11)
measure: Social closeness
timeFrame: Pre- and post-session (week 2, 7, 11)
Secondary outcomes:
Other outcomes:
measure: Heart rate variability and social bonding
timeFrame: Pre- and post-session (week 2, 7, 11)
Locations:
city: Los Angeles
country: United States
facility: Brain and Creativity Institute, University of Southern California
state: California
city: Adelaide
country: Australia
facility: Flinders University
state: South Australia
city: Saint John's
country: Canada
facility: Memorial University of Newfoundland
state: Newfoundland and Labrador
city: Toronto
country: Canada
facility: Toronto Metropolitan University
state: Ontario
city: Montréal
country: Canada
facility: Concordia University
state: Quebec
city: Oldenburg
country: Germany
facility: Carl von Ossietzky Universitat Oldenburg
city: Groningen
country: Netherlands
facility: University of Groningen
Study officials:
affiliation: Toronto Metropolitan University
name: Frank Russo, PhD
role: STUDY_DIRECTOR
References: