A Prospective Multi-center Study Comparing the Performance of the Dysphagia Detection System (DDS) in Detecting Impaired Swallowing Safety and Efficiency as Compared to the Clinical Reference Method - Videofluoroscopic Swallowing Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 452
- 试验地点
- 26
- 主要终点
- Area Under the Receiver Operating Characteristic (ROC) Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for THIN-Ba
研究概览
简要总结
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
详细描述
DDS signals and VFSS will be recorded simultaneously (for the same bolus) using barium contrast agent stimuli prepared in three consistencies: thin, mildly-thick and moderately-thick. Subjects will undergo VFSS with simultaneous DDS using up to 5 boluses of thin barium stimulus ("THIN-Ba"), and up to 4 boluses of barium thickened to mildly ("MILD-Ba") thick and up to 4 boluses of moderately ("MODERATE-Ba") thick barium consistencies using Resource Thicken Up Clear Nestlé Health Science (TUC). 4, 3 and 3 boluses for THIN-Ba, MILD-Ba and MOD-Ba will be analyzed using the classifier algorithms for sensitivity/specificity results. According to the exploratory trial, VFSS data for safety or efficiency can be missing for up to 14% boluses due to quality of VFSS recording. To compensate for potential losses of boluses due to missing gold standard (VFSS) data, 5, 4 and 4 boluses will be collected for the three consistencies respectively . The DDS signals will be sent to a dedicated application software installed at the CRO, which interprets the acceleration data and displays the examination result. The VFSS recording will be sent to CRO and provided for blinded assessment by the independent central VFSS laboratory.The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Screening
- 盲法
- None
盲法说明
An operationally seamless single-arm, prospective, multicenter, single-blinded for central outcomes assessors trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects (over 18 years of age)
- •Hospitalized subjects or outpatients identified as at risk of oropharyngeal dysphagia (using local practice)
- •Patients belong to one of the following groups:
- •Stroke patients
- •Traumatic brain injury
- •Parkinson Disease (PD) stage III or higher by Hoehn and Yahr scale
- •Multiple Sclerosis (MS) above age 60
- •Alzheimer Disease (AD) or other Dementia
- •Other medically complex hospitalized subjects not covered by the
排除标准
- •and identified as at risk of dysphagia
- •Subject is able to comply with VFSS protocol to diagnose dysphagia
- •Subject is able to give voluntary, written informed consent to participate in the clinical investigation and from whom consent has been obtained / or a consultee has consented on he subjects behalf in line with nationally agreed guidelines concerning adults unable to consent for themselves.
- •Exclusion Criteria:
- •Presence of nasogastric / nasojejunal feeding tube at the time of VFSS test
- •Currently has a tracheostomy, or has had a tracheostomy in the past year
- •Had posterior cervical spine surgery and/or carotid endarterectomy in the last 6 months
- •Had significant surgery to the mouth and/or neck, for example resection for oral or pharyngeal cancer, radical neck dissection, anterior cervical spine surgery, orofacial reconstruction, pharyngoplasty, or thyroidectomy. Routine tonsillectomy and/or adenoidectomy are not excluded
- •Experienced non-surgical trauma to the neck (e.g., knife wound) resulting in musculoskeletal or nerve injury in the neck.
- •Received radiation or chemotherapy to the oropharynx or neck for cancer.
- •Allergy to oral radiographic contrast media (specifically barium)
- •Distorted oropharyngeal anatomy (e.g. pharyngeal pouch)
- •Cognitive impairment that prevents them from being able to comply with study instructions and procedures
- •Known to be pregnant at the time of enrollment
- •Currently has significant facial hair at the location of sensor adherence and are unwilling/unable to be shaved
- •Any patients the local investigator finds that participation would not be in patients' best interest
结局指标
主要结局
Area Under the Receiver Operating Characteristic (ROC) Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for THIN-Ba
时间窗: The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.
The primary efficacy of the DDS was measured as the sensitivity \& specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for thin barium (THIN-Ba) stimuli, using 5 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The ROC curve incorporates both sensitivity (true positive rate) and specificity (true negative rate) providing a single assessment incorporating both measures. The higher the total area under the curve, the greater the predictive power of the outcome. Primary analysis for futility was based on 242 subjects (Interim Analysis). The study was terminated based on futility as the AUC for primary endpoint (0.64) was less than the guiding futility bound of 0.75.
次要结局
- The Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba(The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.)
- AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba(The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.)
- The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba(The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.)
- AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba(The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.)
- The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba(The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.)