Benefits of Choir for Older Adults with Unaddressed Hearing Loss (WP2)
NCT Number: NCT06580847
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hearing Loss, Age-Related|Speech Intelligibility|Psychosocial Functioning
Sponsor: Toronto Metropolitan University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 210
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-09
Completion Date: 2026-09

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.

Primary Outcome Measures: 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 Outcome Measures: 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., Pre- and post-session (week 2, 7, 11)