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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 210
- 试验地点
- 14
- 主要终点
- Speech-in-noise perception
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
结局指标
主要结局
Speech-in-noise perception
时间窗: Baseline and completion (week 0 and week 13)
The Coordinate Response Matrix (CRM) generates signal-to-noise ratio (SNR). A lower SNR is indicative of better speech-in-noise perception.
Emotional speech perception
时间窗: Baseline and completion (week 0 and week 13)
The EmoHI is calculated as the mean accuracy of correct responses as a percentage (0 to 100%).
Quality of Life/Wellness
时间窗: Baseline and completion (week 0 and week 13)
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.
Anxiety and Depression
时间窗: Baseline and completion (week 0 and week 13)
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.
Self Esteem
时间窗: Baseline and completion (week 0 and week 13)
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.
Social Connectedness
时间窗: Baseline and completion (week 0 and week 13)
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.
Pitch perception
时间窗: Baseline and completion (week 0 and week 13)
The Frequency Difference Limen (FDL) task evaluates pitch perception threshold. A lower threshold indicates better pitch perception abilities.
Rhythm perception
时间窗: Baseline and completion (week 0 and week 13)
The Beat Alignment Test (BAT) measures rhythm perception accuracy between 0 and 100%.
Timbre perception
时间窗: Baseline and completion (week 0 and week 13)
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.
Higher-level Music perception
时间窗: Baseline and completion (week 0 and week 13)
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.
Positive and Negative Affect
时间窗: Pre- and post-session (week 2, 7, 11)
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.
Anxiety and Discomfort
时间窗: Pre- and post-session (week 2, 7, 11)
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".
Social closeness
时间窗: Pre- and post-session (week 2, 7, 11)
The Inclusion of Other in the Self Scale (IOS) is scored between 1 and 7, with a higher score representing more social closeness.
次要结局
未报告次要终点
研究者
Frank Russo
Principal Investigator
Toronto Metropolitan University