A Study on Building a Voice Cohort for the Development of a Non-face-to-face Machine Learning Diagnostic and Monitoring Platform Using Voice Analysis and Various Sensors in Patients With Dysphagia.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 259
- 试验地点
- 2
- 主要终点
- Voice analysis before and after meals, the results are compared with VFSS to verify significant indicators (residue, aspiration, etc.) by Paired t-test analysis.
研究概览
简要总结
Collection of basic data for real-time analysis and monitoring by measuring what changes in voice occur according to the state of dysphagia using voice analysis and various sensors.
详细描述
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Design : Prospective cohort study
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Setting : Hospital rehabilitation department
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Inclusion criteria of the patient group : Patients scheduled for VFSS examination
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Intervention
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This study will be conducted after collecting basic information such as age, gender, and disease of patients who met the inclusion criteria among patients scheduled to undergo a video fluoroscopic swallowing test (VFSS test) for the diagnosis of dysphagia, and after obtaining guidance and consent through the study description will do.
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Before the subject's VFSS test, "Ah for 5 seconds", after clearing the throat, "Ah for 5 seconds", and briefly cut with a slightly high sound, "Ah. oh Ah.", shut lips lightly and read "Ummm~~~~", read a short sentence.
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While the subject makes the above sound, voice is recorded, video is taken, and integrated sensors such as a microphone (sound detection) sensor is attached to measure changes in each sensor.
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After the VFSS test, participants will repeat the above sound and record the same twice. (As before the test, imaging of the patient's swallowing is also performed.)
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Using voice analysis, various sensor values, and image information, a voice indicator that can predict the amount of suction and residue on the VFSS test is found.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Those who are 19 years of age or older and do not fall under the
排除标准
- •Patients scheduled for VFSS test
- •Patients who can record voices such as "Ah.", "Ummm~~~", short sentences
- •Patients who can attach sensor on their throat
- •Those who voluntarily consent to the clinical trial
- •Exclusion Criteria:
- •Those who do not agree to participate in this study
- •Patients who can not follow Step 1 instructions
- •Patients who can not vocalize or follow to speak
- •Patients who cannot apply the sensor due to skin allergy or hypersensitivity to sensor attachment
- •Other who have comorbidities (e.g., maligant tumors, blood clotting abnormalities, etc.) that are inappropriate for clinical trial participation by the judgment of the researcher 6) Other who are judged by the researcher to be unsuitable for this clinical trial.
研究组 & 干预措施
Normal Group
Healthy volunteers and VFSS patients with PAS 1. Voice recorded before and after swallowing.
干预措施: Voice recording and sensor-based data collection (Diagnostic Test)
Low-Risk Dysphagia Group (Penetration/Residue)
VFSS patients with PAS 2-4. Voice recorded before and after VFSS examination.
干预措施: Voice recording and sensor-based data collection (Diagnostic Test)
High-Risk Dysphagia Group (Aspiration)
VFSS patients with PAS 5-8. Voice recorded before and after VFSS examination.
干预措施: Voice recording and sensor-based data collection (Diagnostic Test)
结局指标
主要结局
Voice analysis before and after meals, the results are compared with VFSS to verify significant indicators (residue, aspiration, etc.) by Paired t-test analysis.
时间窗: Baseline/ Change from baseline when swallowing
By comparing the VFSS swallow test result with the analysis value through voice analysis, the accuracy of the case classified as aspiration in the voice test is used as the primary indicator.
次要结局
未报告次要终点
研究者
Ju Seok Ryu
Professor
Seoul National University Bundang Hospital