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临床试验/NCT05340933
NCT05340933撤回不适用

Speech and Voice As Biomarkers of Physiological Status in Patients with Respiratory Diseases: Proof of Concept in Acute Respiratory Disease Managed in a Pulmonary Hospital

Assistance Publique - Hôpitaux de Paris2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
入组人数
150
试验地点
2
主要终点
Characterize voice analysis as a biomarker of respiratory status and its evolution in patients hospitalized in pneumology using machine learning algorithmshospitalized in pneumology

研究概览

简要总结

Breathing is an automatic vital function that has the peculiarity of being controllable voluntary for actions other than breathing. Speech production is a characteristic example of use of the respiratory system for nonrespiratory purposes. A healthy respiratory system is necessary for speech to be adequately produced and modulated. In patients with respiratory diseases, it becomes difficult to interfere with an automatic control of breathing that is intensely active to compensate for the respiratory deficience. Speech production is impeded, and, reciprocally, speech can generate dyspnea. This study explores the hypothesis that longitudinal changes in speech characteristics will parallel the clinical evolution of acute respiratory episodes. The aim is to validate such changes as prognostic indicators, in the perspective of future telemedicine applications. The hypothesis tested is that of an association between :

  • vocal abnormalities at inclusion (assessed in relation to known data within a normal population (database of holy subjects already constituted) and the initial clinical severity (assessed according to the usual clinical and gasometric criteria):
  • the evolution of vocal abnormalities during the stay and the clinical evolution.

详细描述

In the conceptual framework describe in the "brief summary" section of this document, this observational longitudinal monocentric study will include consecutive patients admitted in a specialised respiratory medicine ward for acute respiratory episodes. Any such episode will be considered be it "de novo" or complicating an underlying chronic respiratory disease. Vocal recordings will be performed daily, and will be analysed according to standard in the fields. Clinical parameters will also be recorded daily (vital signs, treatment intensity, outcome -including requirement for treatment intensification, transfer to the ICU, death, discharge to rehabilitation facility, discharge to home). The clinical follow-up and the vocal follow-up will be confronted to determine if voice analysis has an intrinsic prognostic value, alone, or in combination with clinical signs.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients hospitalised in the Pitié-Salpêtrière Pneumology Department with an acute respiratory illness (pneumonia of any cause, COVID pneumonia depending on the epidemic context, COPD decompensation, etc);
  • whose condition allows conversational exchanges with the nursing staff within the framework of usual care;
  • adults, not protected;
  • understand and speak French fluently;
  • affiliated to the social security system;
  • having read and understood the information leaflet;
  • do not object to the use of their data;

排除标准

  • a clinical condition on admission that is too severe to allow the patient to answer the usual questions of the anamnestic and clinical examination
  • patients with uncorrected hearing problems
  • patients with neurological, otorhinolaryngological or psychiatric pathology

结局指标

主要结局

Characterize voice analysis as a biomarker of respiratory status and its evolution in patients hospitalized in pneumology using machine learning algorithmshospitalized in pneumology

时间窗: 1 month

machine learning algorithms trained on the audio database obtained from patients discussion with medical staff. Voice parameters: respiratory rythms and intensity, and articulatory performances, will be extracted from voice recording, combined and analysed by the algorithms.

次要结局

  • Correlation of the used of algorithms based on voice and medical diagnosis.(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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