Benefits of Choir for Older Adults With Unaddressed Hearing Loss (WP2)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorToronto Metropolitan University
About this trial
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
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Group Singing
Behavioral12 week choir program consisting of 1.5 hours of in-person instruction per week.
Audiobook Club
Behavioral12 week audiobook club program consisting of 1.5 hours of in-person discussion per week.
Treatment groups
210 Participants
are divided into 2 treatment groupsGroup A: Group SingingExperimental treatment 1 intervention
Group B: Audiobook ClubActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and completion (week 0 and week 13)2
Emotional speech perception
The EmoHI is calculated as the mean accuracy of correct responses as a percentage (0 to 100%).
Time frame
Baseline and completion (week 0 and week 13)3
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.
Time frame
Baseline and completion (week 0 and week 13)4
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.
Time frame
Baseline and completion (week 0 and week 13)Other outcomes
1
Heart rate variability and social bonding
Heart rate variability (HRV) is a proxy measure of social bonding. Higher HRV is anticipated to be associated with higher levels of social bonding.
Time frame
Pre- and post-session (week 2, 7, 11)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Toronto Metropolitan University
Lead sponsor
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
Source ClinicalTrials.gov