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High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease

2018年8月23日 更新者:NYU Langone Health

The overall goal of this T2 translational research project is to pilot an interdisciplinary high-intensity group singing program to improve speech and swallowing in patients with Parkinson's Disease (PD) and to explore the impact of this program on quality of life (QOL). This research has three specific aims: 1) Determine the effects of a high-intensity group vocal training program on vocal function and laryngeal structure; 2) Determine the transference of vocal training to laryngeal aspects of swallowing; 3) Determine the effect of patient-reported changes in Quality of Life (QOL) as the result of participation in a group vocal training program.

Twenty patients with Parkinson Disease will be recruited from the Fresco Institute for Parkinson's & Movement Disorders to participate in a 12-week vocal training program. The program will train participants using maximum vocal function exercises targeting vocal deficits specific to PD. Choral singing therapy sessions will be conducted once weekly with daily home practice exercises based on principles that have been successful in other intensive PD vocal exercise programs.

研究概览

详细说明

Deterioration of speech and swallowing is a hallmark of Parkinson Disease (PD). There is emerging evidence that choral singing benefits people with PD across a range of modalities. Despite the increasing popularity of "Parkinson's choirs", rigorous study of these benefits is lacking. There is a large body of evidence that intense vocal training improves speech and communication for people with PD. However, the intense training places high demands on clinical and patient resources and, due to its individualized approach, lacks the potential psycho-social benefits of a group intervention.

It is hypothesized singing training program will increase vocal loudness, range of articulation, and prosodic variation during speech. Additionally, given existing evidence for neuroplastic transference of voice-related interventions to swallowing function, laryngeal components of swallowing function will also improve post-intervention. Finally, investigators expect to see improvements in patient-reported QOL measures corresponding with improved speech and laryngeal function and/or as the result of group interaction.

All participants will complete a standardized battery of assessment pre- and post- treatment including acoustic and aerodynamic assessment of voice, dynamic magnetic resonance imaging of speech and swallowing, and videofluoroscopic evaluation of swallowing. The outcome of this work will be a rigorous understanding of how choral singing therapy can positively impact the voice, swallowing function, and quality of life for patients with PD.

研究类型

介入性

注册 (实际的)

18

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。

学习地点

    • New York
      • New York、New York、美国、10016
        • New York University 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

不超过 100年 (孩子、成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Confirmed diagnosis of Stage One, Two or Three on the Hoehn and Yahr Staging of Parkinson's Disease
  • Current swallowing severity of normal, mild, or moderate without aspiration
  • Stable regimen of anti-PD medication for >30 days

Exclusion Criteria:

  • Prior voice and/or swallowing therapy related to PD
  • History of head and neck cancer
  • History of oropharyngeal or laryngeal surgery
  • Current or former smoker (quit < 5 years)

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Behavioral vocal training
12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.
Choral (group) singing therapy sessions will be conducted once weekly and daily home practice exercises will be assigned. All vocal exercises are based on principles that have been successful in other intensive Parkinson Disease vocal exercise programs.

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
Average speaking intensity (dB SPL)
大体时间:19 Weeks
Tasks: Sustained phonation of /a/ at a comfortable pitch and loudness for 4 seconds; pitch glide throughout physiologic vocal range on /a/; standardized reading passage (CAPE-V sentences); 1-minute monologue in response to an emotionally neutral question; singing a standard song.
19 Weeks

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。

调查人员

  • 首席研究员:Aaron Johnson, MD、NYU Langone Health

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)

2017年8月22日

初级完成 (实际的)

2017年12月13日

研究完成 (实际的)

2017年12月13日

研究注册日期

首次提交

2017年8月24日

首先提交符合 QC 标准的

2017年8月24日

首次发布 (实际的)

2017年8月28日

研究记录更新

最后更新发布 (实际的)

2018年8月27日

上次提交的符合 QC 标准的更新

2018年8月23日

最后验证

2018年8月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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.

Choral (group) singing therapy sessions的临床试验

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