跳至主要内容
临床试验/NCT03133611
NCT03133611Unknown不适用

Automatic Acoustic Speech Analysis and REM Sleep Behaviour Disorder for Detecting Subjects at High Risk for Parkinson's Disease and Other Alpha-synucleinopathies

Czech Technical University in Prague7 个研究点 分布在 7 个国家目标入组 350 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
350
试验地点
7
主要终点
Motor Speech Disorder Examination (MSDE)

研究概览

简要总结

Speech is an important indicator of motor function and movement coordination and can be extremely sensitive to involvement in the course of neurologic diseases. The aim of this project is to discover for the first time using simple speech recording and high end pattern analysis preclinical stages of disabling central nervous system disorders including Parkinson's disease and other alpha-synucleinopathies in "at high risk" patients with REM sleep behavior disorder and thus provide one essential prerequisite for trials on REM sleep behavior disorder with preventive therapy.

详细描述

Seven centers of excellence in sleep research will investigate speech and other clinical symptoms in more than 100 subjects with REM sleep behavior disorder. Analyses of a number of unique speech dimensions based upon three fundamental categories of simple speaking tasks will be used to search for specific prodromal alterations in speech patterns in REM sleep behavior disorder, compared to age- and gender-matched patients with early Parkinson's disease and healthy control subjects. Robust algorithms allowing automated speech analysis will be developed and optimized through English, German, French, Czech and Italian languages. Early motor dysfunction strongly predicts Parkinson's disease and other alpha-synucleinopathies. In this regard, vocal assessment has intriguing potential advances as is non-invasive, inexpensive, simple to administer and scalable to large population with possibility to perform recordings remotely, even by telephone from patients' home. Speech analysis may serve as a simple tool to screen large populations for the risk to develop Parkinson's disease. If speech impairment appears to be a strong biomarker of early motor dysfunction, the screening of speech changes may improve stratification for future neuroprotective therapies for Parkinson's disease and other synucleinopathies.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •for subjects with Parkinson's disease (PD):
  • •Diagnosed based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease including the presence of bradykinesia in combination with either rest tremor, rigidity, or both;
  • •Hoehn & Yahr stage 1-2 in the defined OFF state;
  • •Disease duration from diagnosis < 5 years;
  • •No motor fluctuations or dyskinesias;
  • •On stable dose of medication in last four weeks;
  • •Onset of PD after 50 years;
  • •No history of communication or neurological disorders unrelated to PD;
  • •Not currently involved in any speech therapy;
  • •Inclusion Criteria for subjects with REM Sleep Behaviour Disorder (RBD):
  • •Fulfill criteria for RBD based on polysomnography according to the standard International Classification of Sleep Disorders diagnostic criteria, 3rd edition;
  • •Onset of RBD after 50 years;
  • •No history of communication or neurological disorders.
  • •Inclusion Criteria for healthy control subjects:
  • •No history of communication or neurological disorders, parasomnias and other sleep disorders with important severity;
  • •No regular benzodiazepines, hypnotics and melatonin intake.

排除标准

  • •(for all the arms) Inability to speak and read a text aloud.

研究组 & 干预措施

Parkinson's disease

Other

Speech assessment. Routine clinical assessment.

干预措施: Speech assessment (Other)

Parkinson's disease

Other

Speech assessment. Routine clinical assessment.

干预措施: Routine clinical assessment (Other)

REM sleep behaviour disorder

Other

Speech assessment. Routine clinical assessment.

干预措施: Speech assessment (Other)

REM sleep behaviour disorder

Other

Speech assessment. Routine clinical assessment.

干预措施: Routine clinical assessment (Other)

Healthy controls

Other

Speech assessment. Routine clinical assessment.

干预措施: Speech assessment (Other)

Healthy controls

Other

Speech assessment. Routine clinical assessment.

干预措施: Routine clinical assessment (Other)

结局指标

主要结局

Motor Speech Disorder Examination (MSDE)

时间窗: Within one session (15 minutes)

Quantitative acoustic assessment of several deviant speech dimensions connected with phonatory, articulatory, and prosodic abnormalities in hypokinetic dysarthria of Parkinson's disease.

次要结局

  • SCOPA-AUT(Within one session (30 minutes))
  • MDS Unified Parkinson's Disease Rating Scale (MDS-UPDRS)(Within one session (30 minutes))
  • Montreal Cognitive Assessment (MoCA)(Within one session (15 minutes))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (7)

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