Computerized Acoustic Swallowing Evaluation in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Acoustic Signal of Normal Swallowing Pattern
研究概览
简要总结
It is the purpose of this study to determine if a commercially available electronic stethoscope synchronized with an smart phone or iPad application can be used as an accurate and objective screening tool for measuring dysphagia. The investigators plan to do so in two phases; in Phase I the investigators will recruit normal subjects to establish normal swallowing patterns, as well as optimal sensor placement; and in Phase II the investigators will compare the recordings obtained by the electronic stethoscope with those obtained using videofluoroscopy.
详细描述
In this study, the investigators will use commercially available electronic stethoscope to assess dysphagia in patients who have recently experienced a stroke. The Eko Core electronic stethoscope is approved by the Food and Drug Agency (FDA) is currently available for use in the health care context.
Phase I
In the first phase of this study the investigators will try to establish the electronic stethoscope's measurements for normal swallowing patterns. The investigators will recruit healthy controls and auscultate for swallowing sounds at three locations: in the anterolateral section of the neck, in the posterior section of the neck, and in the superior sternum as illustrated in Figure 1. After the sensors are placed, participants will be asked to perform the following tests:
- Dry Swallow - ask participant to swallow their saliva
- Ask participant to swallow 1 teaspoon of water
- Ask participant to swallow 3 ounces of water (continuous)
- Ask participant to swallow one teaspoon of applesauce
- Ask participant to chew one cracker Healthy subjects will be recruited by advertisement using a flyer. Interested individuals will be able contact the study coordinator by email or phone. Subsequently, the participants will present for consenting and testing at the CSMC rehabilitation gym (North Tower 7215) or Pacific Theaters Building (116 N. Robertson) at a mutually agreed time.
The results of these tests will be used to determine the electronic stethoscope's measurements for a normal swallowing pattern.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Admitted to CSMC for acute ischemic or hemorrhagic stroke, or TIA
- •No history of head and/or neck cancer
- •No tracheostomy or ventilator
- •Able to follow simple one step commands
- •18 years of age or older
排除标准
- •Not admitted to CSMC for acute ischemic or hemorrhagic stroke or TIA
- •History of head and/or neck cancer
- •Tracheostomy or ventilator
- •Unable to follow simple one step commands
- •Less than 18 years of age.
结局指标
主要结局
Acoustic Signal of Normal Swallowing Pattern
时间窗: 1 minute
To establish the acoustic signals associated wtih a normal pattern of swallowing using an electronic stethoscope
Acoustic Signal of Swallowing in the Stroke Population
时间窗: 1 minute
To establish the acoustic signals associated with neurologic pattern of swallowing using an electronic stethoscope
次要结局
未报告次要终点
研究者
Pamela Roberts
Director
Cedars-Sinai Medical Center