Trial Outcomes & Findings for Videofluoroscopic Swallowing Study (VFSS) (NCT NCT03387267)

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

452 participants

Primary outcome timeframe

The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.

Results posted on

2025-12-19

Participant Flow

The trial was stopped on 23 July 2018 when the announcement of futility stopping was made.

Participant milestones

Participant milestones
Measure	Single-arm Dysphagia Detection System 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. Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.
Overall Study STARTED	452
Overall Study COMPLETED	438
Overall Study NOT COMPLETED	14

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Videofluoroscopic Swallowing Study (VFSS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single-arm Dysphagia Detection System n=452 Participants 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. Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.
Age, Continuous	68 years n=8 Participants
Sex: Female, Male Female	166 Participants n=8 Participants
Sex: Female, Male Male	286 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=8 Participants
Race (NIH/OMB) Asian	20 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	78 Participants n=8 Participants
Race (NIH/OMB) White	331 Participants n=8 Participants
Race (NIH/OMB) More than one race	17 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=8 Participants

PRIMARY outcome

Timeframe: The study procedure of simultaneous VFSS and DDS measurement using thin barium (THIN-Ba) was completed in one day for each subject.

Population: The interim analysis data consists of all subjects enrolled and completed before the data cut-off date. The analysis data set consisted of N=253 subjects with N=242 subjects meeting all inclusion-exclusion criteria and having at least one successfully completed Thin bolus swallow measurement (both VFS and DDS).

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.

Outcome measures

Outcome measures
Measure	Single-arm Dysphagia Detection System n=242 Participants 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. Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.
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	0.64 Probability

SECONDARY outcome

Timeframe: The study procedure of simultaneous VFSS and DDS measurement using mild barium (MILD-Ba) was completed in one day for each subject.

Population: Primary analysis for futility was based on 242 subjects (Interim Analysis).

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 measures

Outcome measures
Measure	Single-arm Dysphagia Detection System n=242 Participants 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. Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba	0.65 Probability

SECONDARY outcome

Timeframe: The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.

Population: Primary analysis for futility was based on 242 subjects (Interim Analysis).

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 measures

Outcome measures
Measure	Single-arm Dysphagia Detection System n=242 Participants 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. Dysphagia Detection System: The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.
AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba	0.576 Probability

SECONDARY outcome

Timeframe: The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.

Population: The analysis for secondary endpoints were to be carried out in a hierarchical fashion in the specified order, only if primary endpoint was met: 1. swallow safety using MILD-Ba 2. swallow safety using MOD-Ba 3. swallow efficiency using THIN-Ba 4. swallow efficiency using MILD-Ba 5. swallow efficiency using MOD-Ba Outcomes on swallow efficiency were not analyzed.

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 measures

Outcome data not reported

SECONDARY outcome

Timeframe: The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.

Population: The analysis for secondary endpoints were to be carried out in a hierarchical fashion in the specified order, only if primary endpoint was met: 1. swallow safety using MILD-Ba 2. swallow safety using MOD-Ba 3. swallow efficiency using THIN-Ba 4. swallow efficiency using MILD-Ba 5. swallow efficiency using MOD-Ba Outcomes on swallow efficiency were not analyzed.

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 measures

Outcome data not reported

SECONDARY outcome

Timeframe: The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.

Population: The analysis for secondary endpoints were to be carried out in a hierarchical fashion in the specified order, only if primary endpoint was met: 1. swallow safety using MILD-Ba 2. swallow safety using MOD-Ba 3. swallow efficiency using THIN-Ba 4. swallow efficiency using MILD-Ba 5. swallow efficiency using MOD-Ba Outcomes on swallow efficiency were not analyzed.

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 measures

Outcome data not reported

Adverse Events

Dysphagia Detection System (DDS)

Serious events: 5 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Dysphagia Detection System (DDS) n=438 participants at risk A trial to test DDS in assessing swallowing safety and efficiency in patients at risk of oropharyngeal dysphagia. Each patient will go through a series of swallows using 5 Thin-BA boluses, 4 Mild-BA boluses and 4 Mod-BA boluses.
Nervous system disorders Haemorrhage intracranial	0.23% 1/438 • Number of events 1 • The study procedure of simultaneous VFSS and DDS measurement were completed in one day and the subjects were followed for 2 business days after the study procedure to monitor for adverse events.
Nervous system disorders Seizure	0.23% 1/438 • Number of events 1 • The study procedure of simultaneous VFSS and DDS measurement were completed in one day and the subjects were followed for 2 business days after the study procedure to monitor for adverse events.
Surgical and medical procedures Gastrostomy	0.46% 2/438 • Number of events 2 • The study procedure of simultaneous VFSS and DDS measurement were completed in one day and the subjects were followed for 2 business days after the study procedure to monitor for adverse events.
Gastrointestinal disorders Pharyngo-oesophageal diverticulum	0.23% 1/438 • Number of events 1 • The study procedure of simultaneous VFSS and DDS measurement were completed in one day and the subjects were followed for 2 business days after the study procedure to monitor for adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Kemuel Reyes

Nestlé Health Science

Phone: (908) 333-9379

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place