Brief Summary
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.
Brief Title
Videofluoroscopic Swallowing Study (VFSS)
Detailed Description
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Stroke
Parkinson Disease
Multiple Sclerosis
Oropharyngeal Dysphagia
Alzheimer Disease
Dementia
Eligibility Criteria
Inclusion Criteria:
* 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 exclusion criteria 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
* 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 exclusion criteria 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
Inclusion Criteria
Inclusion Criteria:
* 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
* 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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03387267
Org Class
Industry
Org Full Name
Société des Produits Nestlé (SPN)
Org Study Id
16.21.CLI
Overall Status
Terminated
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
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
Primary Outcomes
Outcome Description
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.
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.
Outcome Measure
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
Outcome Time Frame
The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.
Secondary Outcomes
Outcome Description
The sensitivity \& specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for MILD barium (MILD-Ba) stimuli, using 4 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The higher the total AUC, the greater the predictive power of the outcome.
Outcome Time Frame
The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.
Outcome Measure
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba
Outcome Description
The sensitivity \& specificity obtained from comparing the DDS predicted swallow safety outcome (binary) with the clinical reference standard VFSS swallow safety outcome (binary) for MODERATE barium (MOD-Ba) stimuli, using 3 boluses per subject protocol. ROC (AUC) was used for comparing the 2 algorithms. The higher the total AUC, the greater the predictive power of the outcome.
Outcome Time Frame
The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.
Outcome Measure
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba
Outcome Description
The sensitivity \& specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for Thin barium (THIN-Ba) stimuli.
Outcome Time Frame
The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.
Outcome Measure
The Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba
Outcome Description
The sensitivity \& specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for MILD-Ba.
Outcome Time Frame
The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.
Outcome Measure
The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba
Outcome Description
The sensitivity \& specificity obtained from comparing the DDS predicted swallow efficiency outcome (binary) with the clinical reference standard VFSS swallow efficiency outcome (binary) for MOD-Ba stimuli.
Outcome Time Frame
The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.
Outcome Measure
The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Tomoko Kitago
Investigator Email
Investigator Phone
Categories Mesh Debug
Brain, Spinal Cord & Nervous System --- STROKE
Alzheimer's --- DEMENTIA
Brain, Spinal Cord & Nervous System --- CEREBROVASCULAR DISORDERS
Alzheimer's --- BRAIN DISEASES
Brain, Spinal Cord & Nervous System --- BRAIN DISEASES
Brain, Spine & Nerve Cancers --- BRAIN DISEASES
Alzheimer's --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- CENTRAL NERVOUS SYSTEM DISEASES
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Blood & Bone Marrow Cancers --- VASCULAR DISEASES
Heart/Cardiovascular --- VASCULAR DISEASES
Blood Disorders --- CARDIOVASCULAR DISEASES
Blood & Bone Marrow Cancers --- CARDIOVASCULAR DISEASES
Heart/Cardiovascular --- CARDIOVASCULAR DISEASES
Infectious Disease --- IMMUNE SYSTEM DISEASES
Lung --- IMMUNE SYSTEM DISEASES
Gastrointestinal (GI) Cancers --- GASTROINTESTINAL DISEASES
Digestive System --- GASTROINTESTINAL DISEASES
Gastrointestinal (GI) Cancers --- DIGESTIVE SYSTEM DISEASES
Digestive System --- DIGESTIVE SYSTEM DISEASES
Liver --- DIGESTIVE SYSTEM DISEASES
Head & Neck --- OTORHINOLARYNGOLOGIC DISEASES
Alzheimer's --- NEUROCOGNITIVE DISORDERS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
MeSH Terms
STROKE
PARKINSON DISEASE
MULTIPLE SCLEROSIS
DEGLUTITION DISORDERS
ALZHEIMER DISEASE
DEMENTIA
CEREBROVASCULAR DISORDERS
BRAIN DISEASES
CENTRAL NERVOUS SYSTEM DISEASES
NERVOUS SYSTEM DISEASES
VASCULAR DISEASES
CARDIOVASCULAR DISEASES
PARKINSONIAN DISORDERS
BASAL GANGLIA DISEASES
MOVEMENT DISORDERS
SYNUCLEINOPATHIES
NEURODEGENERATIVE DISEASES
DEMYELINATING AUTOIMMUNE DISEASES, CNS
AUTOIMMUNE DISEASES OF THE NERVOUS SYSTEM
DEMYELINATING DISEASES
AUTOIMMUNE DISEASES
IMMUNE SYSTEM DISEASES
ESOPHAGEAL DISEASES
GASTROINTESTINAL DISEASES
DIGESTIVE SYSTEM DISEASES
PHARYNGEAL DISEASES
OTORHINOLARYNGOLOGIC DISEASES
TAUOPATHIES
NEUROCOGNITIVE DISORDERS
MENTAL DISORDERS