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临床试验/CTRI/2024/03/064909
CTRI/2024/03/064909招募中不适用

Modeling of health states using vocal biomarker analysis of passive audio recordings

Sonde Health4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年4月8日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
4
主要终点
1. Dataset Compilation: To compile a comprehensive reference dataset of vocal samples, gathered passively from individuals with respiratory conditions as well as healthy volunteers, to serve as a benchmark for analysis.

研究概览

简要总结

This study is designed to refine vocal analysis techniques by integrating distinct vocal characteristics, known as vocal biomarkers (VB), which are indicative of a variety of health states. Conventionally, VB development has utilized "cued" voice samples—these are recordings captured when participants are prompted to produce sounds or speech based on specific guidelines. Established VB models have shown success in discerning between certain respiratory conditions (such as asthma, chronic obstructive pulmonary disease (COPD), and COVID-19) and healthy states, through the elicitation of sustained vowel sounds, particularly the "ahh" sound. Moreover, analyses of vocal features from 30-second segments of natural speech have been effective in differentiating levels of mental health symptomatology. This research intends to advance the application of VB methods to "passive" voice recordings. These recordings are captured via devices that continuously process audio data and identify individual users without active user engagement. By utilizing these passively obtained signals for VB analysis, the study aims to remove the requirement for overt participant interaction, thereby allowing the technology to function unobtrusively, much like current fitness tracking devices. To achieve this transition, it is necessary to adapt the established cued VB techniques to a passive collection environment. This adaptation will require the compilation of a new passive VB dataset, which will then be compared and validated against cued recordings from the same participants. The successful completion of this process is crucial to enhance the practicality and efficacy of VB technology for health state assessment.

·       Respiratory Patients: 400 adults with Asthma (200) or COPD (200).

·       Healthy Volunteers: 100 adults without any chronic or acute health, especially respiratory conditions.

 Criteria:

·       Age: 18+

Gender: Balanced male and female representation

The Sonde One app will be used to collect voice samples and health information from participants. This is an observational study without intervention. Participant Duration:  Single visit, approximately 30 minutes.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Agreement with the subject consent information presented on the Sonde app.
  • Stated willingness and ability to comply with all study procedures
  • Male or female, aged 18 or above
  • Fluent in any of the designated languages selected for the study
  • Pregnant women are allowed to participate
  • Have a medical diagnosis of asthma or COPD if participating as a patient (asthma and COPD as comorbidities are allowed)
  • No respiratory diagnosis if participating as non-patient volunteer.
  • Non-respiratory diagnoses are allowed unless mentioned in the exclusion criteria.

排除标准

  • Speech or voice disorder (known diagnosis or clinician judgment)
  • Patient in critical conditions requiring immediate medical attention
  • Chronic respiratory conditions other than asthma or COPD
  • Acute respiratory conditions (upper or lower respiratory tract viral or bacteriological infections)
  • Participation in medication studies or trials
  • Severe psychiatric diagnosis (e.g. schizophrenia, psychotic disorder)
  • Dementia, Alzheimer’s Disease, or similar cognitive impairment diagnosis
  • Movement disorder (e.g. Parkinson’s Disease, Huntington’s Disease).

结局指标

主要结局

1. Dataset Compilation: To compile a comprehensive reference dataset of vocal samples, gathered passively from individuals with respiratory conditions as well as healthy volunteers, to serve as a benchmark for analysis.

时间窗: Day zero (baseline)

次要结局

  • 2. Authentication Algorithm Assessment: To assess the feasibility & accuracy of user authentication algorithms by analyzing voice samples collected passively, ensuring reliable participant identification.(3. Vocal Feature Analysis: To conduct a comparative analysis of vocal & prosodic features between passively collected voice samples & those obtained through cued vocal elicitations, to validate the efficacy of passive collection methods.)

研究者

发起方
Sonde Health
申办方类型
Other [Private Company]
责任方
Principal Investigator
主要研究者

Dr Shashikant Madrewar

Dr Madrevars chest and multispeciality hospital

研究点 (4)

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