Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music
This study examines whether Clinically Designed Improvisatory Music (CDIM) can reduce anxiety in people living with Alzheimer's disease and anxiety (AD-A), and whether it can also lessen caregiver burden. CDIM is a live, receptive music-based intervention that uses slow tempi, simple diatonic melodic lines, soft dynamics, and periodic pauses to promote relaxation. As described in the proposal, CDIM has previously been shown to reduce stress and improve physiological markers such as heart rate, blood pressure, and EEG alpha/beta ratios (CDIM significantly decreased physical stress symptoms and patients also reported positive emotional outcomes and EEG readings showed increased alpha/beta brainwave ratios ).
The study will enroll 30 dyads (individuals with AD-A and their caregivers). Dyads will be randomly assigned to either CDIM or a control intervention (CI) consisting of calming short stories read aloud. Both interventions include eight 30-minute sessions over four weeks, delivered in alternating in-person and virtual formats.
The primary goal is to determine whether CDIM is feasible and effective in reducing anxiety in individuals with AD-A, measured by the Rating Anxiety in Dementia (RAID) scale, and in reducing caregiver burden, measured by the Zarit Burden Interview (ZBI). The study also evaluates changes in heart rate and blood pressure as indicators of autonomic regulation.
A second goal is to explore whether CDIM improves central auditory processing, assessed using the frequency-following response (FFR). The proposal notes that central auditory processing declines with age and dementia and may contribute to anxiety. FFR will be measured before and after the intervention to determine whether CDIM enhances neural timing and response magnitude.
Overall, this pilot study aims to determine whether CDIM is a feasible, safe, and potentially effective non-pharmacological intervention for reducing anxiety in individuals with AD-A and decreasing caregiver burden, while also investigating its underlying neurophysiological mechanisms.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Borna Bonakdarpour - Associate Professor, MD, FAAN, FANA
- 电话号码:(312) 503-5170
- 邮箱:bbk@northwestern.edu
学习地点
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Illinois
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Chicago、Illinois、美国、60611
- 招聘中
- Northwestern University Feinberg School of Medicine
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria
- Clinical diagnosis of Alzheimer's Disease
- Positive Alzheimer's disease biomarkers (blood test, amyloid PET scan or CSF)
- Mini-mental State Exam (MMSE) >=15
- Rating for Anxiety in Dementia (RAID) score > 8
Exclusion Criteria
- Significant hearing impairments
- Major comorbidities Beck Depression Inventory (BDI) scores above > 10'
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Clinically Designed Improvisatory Music
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Clinically Designed Improvisatory Music (CDIM) is live, slow-tempo, diatonic improvisation played with soft dynamics and periodic pauses.
It uses meterless melodic lines, vocal-range pitches, and gentle harmonic intervals to promote neural entrainment, parasympathetic activation, and anxiety reduction in listeners.
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有源比较器:Listening to storytelling
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Participants will listen to calming short stories within 30 minutes.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Rating Anxiety in Dementia (RAID)
大体时间:From enrollment to the end of treatment at 8 weeks.
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RAID is a structured clinical scale measuring anxiety in dementia.
It will be evaluated 3 times, 4 weeks apart.
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From enrollment to the end of treatment at 8 weeks.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Frequency Following Response (FFR)
大体时间:It will be evaluated at baseline and up to a week after intervention.
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FFR is a scalp-recorded neural measure capturing precise subcortical encoding of sound timing, frequency, and speech acoustics.
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It will be evaluated at baseline and up to a week after intervention.
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Heart rate
大体时间:Measured at baseline up to a week after intervention.
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Heart rate per minute
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Measured at baseline up to a week after intervention.
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Blood pressure
大体时间:Measured at baseline up to a week after intervention.
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Blood pressure measured using a blood pressure machine.
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Measured at baseline up to a week after intervention.
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Respiratory Rate
大体时间:Measured at baseline and up to a week after intervention.
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Number of respirations per minutes.
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Measured at baseline and up to a week after intervention.
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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