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临床试验/NCT07347899
NCT07347899已完成不适用

A Preliminary Study on the Phonetics of Resonance and Articulation Disorders Caused by Defects of the Oral and Maxillofacial Speech Organs and Speech Therapy

Yudong Xiao1 个研究点 分布在 1 个国家目标入组 501 人开始时间: 2017年7月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
501
试验地点
1
主要终点
AUC value

研究概览

简要总结

Participants diagnosed with oral cancer, oropharyngeal cancer, or oral potentially malignant lesions, as well as healthy controls, had their speech audio recordings collected for the development and validation of AI-driven models for diagnosis and prognosis prediction of oral cancer and oropharyngeal cancer.

详细描述

Participants were instructed to articulate three sustained vowels (/a/, /i/, /u/) repeatedly at a moderate volume and pace, with three repetitions per vowel and each utterance lasting at least one second. We developed a neuromorphic computing framework that orthogonally decomposes acoustic features into ultra-dimensional omics representations, enabling the characterization of both localized lesions and systemic physiological conditions. The study collected a comprehensive spectrum of biological profiles, including sociodemographic characteristics, tumor metrics, oral function-related factors, patient-reported outcome measures (PROMs), immunoinflammatory indices, and general health status indicators, to thoroughly investigate the paralinguistic representations of transformed speech omics features. These features were then rigorously evaluated for their clinical efficacy across multiple diagnostic tasks, including screening, early detection, pathological diagnosis, disease staging, and risk factor identification.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • diagnosed as having OC or OPC regardless of concrete pathological subtype (e.g., epithelial, adenoid, odontogenic)
  • without a history of other tumor-related treatment before the initial evaluation, such as radiotherapy and chemotherapy
  • native Chinese speakers

排除标准

  • hearing impairment
  • history of stuttering, cerebrovascular accident, brain trauma, neurodegenerative diseases
  • severe dental or maxillofacial deformity
  • cleft lip, cleft palate, and related post-treatment status
  • severe cardiology conditions, breathing/pulmonology disorders, psychiatric disorders or other illnesses preventing patients from receiving standard surgery

研究组 & 干预措施

healthy control and oral potentially malignant lesion

Speakers with oral potentially malignant lesions or healthy status

oral cancer and oropharyngeal cancer

Patients diagnosed with oral cancer or oropharyngeal cancer

结局指标

主要结局

AUC value

时间窗: From enrollment to the report of surgical pathology,up to two weeks.

Area under the receiver operating characteristic curve (AUC) for discriminating OC/OPC from healthy controls

次要结局

未报告次要终点

研究者

发起方
Yudong Xiao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yudong Xiao

Dr.

Hospital of Stomatology, Sun Yat-Sen University

研究点 (1)

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