此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Central Auditory Processing Modulation Underlying Anxiety Reduction Using Clinically Designed Improvisatory Music

2026年8月16日 更新者:Borna Bonakdarpour、Northwestern University

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

介入性

注册 (估计的)

30

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

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

    • Illinois
      • Chicago、Illinois、美国、60611
        • 招聘中
        • Northwestern University Feinberg School of Medicine

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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
实验性的:Clinically Designed Improvisatory Music
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.
有源比较器:Listening to storytelling
Participants will listen to calming short stories within 30 minutes.

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
Rating Anxiety in Dementia (RAID)
大体时间:From enrollment to the end of treatment at 8 weeks.
RAID is a structured clinical scale measuring anxiety in dementia. It will be evaluated 3 times, 4 weeks apart.
From enrollment to the end of treatment at 8 weeks.

次要结果测量

结果测量
措施说明
大体时间
Frequency Following Response (FFR)
大体时间:It will be evaluated at baseline and up to a week after intervention.
FFR is a scalp-recorded neural measure capturing precise subcortical encoding of sound timing, frequency, and speech acoustics.
It will be evaluated at baseline and up to a week after intervention.
Heart rate
大体时间:Measured at baseline up to a week after intervention.
Heart rate per minute
Measured at baseline up to a week after intervention.
Blood pressure
大体时间:Measured at baseline up to a week after intervention.
Blood pressure measured using a blood pressure machine.
Measured at baseline up to a week after intervention.
Respiratory Rate
大体时间:Measured at baseline and up to a week after intervention.
Number of respirations per minutes.
Measured at baseline and up to a week after intervention.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月2日

初级完成 (估计的)

2026年12月15日

研究完成 (估计的)

2026年12月15日

研究注册日期

首次提交

2026年8月9日

首先提交符合 QC 标准的

2026年8月16日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月16日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅