Novel Acoustic Biopatch for the Investigation of Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Normalized Surface Acoustic Swallowing Signal
研究概览
简要总结
This study aims to collect swallowing acoustics with a novel non-invasive wearable surface microphone device during routine work-up, videofluoroscopic swallow study (VFSS), of patients with dysphagia (swallowing trouble). The collected microphone data will be analyzed to find the pattern of abnormal swallowing by machine learning algorithm.
详细描述
Difficulty swallowing is a very common laryngeal problem affecting many individuals. This study aims to optimize and validate a device to detect dysphagia without invasive procedures. This is an investigational nanomembrane patch, which is a thin film, that will be attached to the subject's chin to check the activity of their muscles. The patch is designed to determine the movement of their muscles and acoustics while swallowing.
This is a prospective cohort study. Dysphagic individuals with stroke visiting Emory University Hospital and Emory Midtown hospital will be asked to participate in the study. Individuals above the age of 40 years will be recruited. The study will be explained in detail to the individuals. After which a written signed consent will be obtained by research personnel before performing any research procedure. The biopatch will be placed and calibrated in dysphagic individuals at the time of performing a barium swallowing test. The collected medical (dysphagia questionnaire) data and demographic data will be collected and saved in Emory REDCap.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis or suspected stroke
- •Stroke with additional neurological disorders
- •Age between 40 and 85
- •Male and Female
- •Scheduled to VFSS due to suspected dysphagia, which is determined by bedside water swallowing test and EAT-10 questionnaire as a standard of care.
排除标准
- •BMI>35 as an exclusion criteria to recruit participants due to limited transmission of acoustics through increased subcutaneous fat.
- •Head and neck cancer treatment history
研究组 & 干预措施
Novel Acoustic Biopatch for the Investigation of Dysphagia Cohort
The device is composed of a sensor (disposable part) and a circuit (reusable part).
The device will be applied to the anterior neck of dysphagia symptomatic patients who will be accessed with routine dysphagia investigation, such as standard swallowing evaluation with a modified barium swallow (VFSS). Device will be applied by authorized investigators to specific area to target specific neck muscles where no interference occurs for X-ray imaging (VFSS) interpretation. Acoustic data collected via device will be compared with X-ray imaging (VFSS) to train Convolutional neural network (CNN) algorithm to improve accuracy and to determine accuracy of device.
干预措施: Microphone device (Device)
结局指标
主要结局
Normalized Surface Acoustic Swallowing Signal
时间窗: Up to 30 min post-intervention
Surface acoustic swallowing signals will be collected using a wearable biopatch containing a microphone, placed on study participants. Raw acoustic data will be recorded in voltage and subsequently normalized against background acoustic levels, resulting in a unitless measure expressed in arbitrary units (a.u.).
次要结局
- Time to apply device to patients(Up to 30 min post-intervention)
研究者
Hyojung Choo
Assistant Professor
Emory University