PORSCHE: Videofluoroscopic Swallowing Study (VFSS)

Sponsor
Nestlé (Industry)
Overall Status
Terminated
CT.gov ID
NCT03387267
Collaborator
Cytel Inc. (Industry), Regulatory and Clinical Research Institute Inc (Other), Nestec Ltd. (Industry)
452
13
1
8.9
34.8
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Dysphagia Detection System
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
452 participants
Allocation:
N/A
Intervention Model:
Sequential Assignment
Intervention Model Description:
The clinical trial will initially start as a 3-look group sequential design (GSD). Alpha-spending will be calculated using Lan-DeMets spending function (with O'Brien-Fleming parameter). At the first interim analysis (IA-1) the threshold on the ROC curve may be re-computed using the ROC curve generated using the IA-1 data, in which case, the validation trial would start afresh following IA-1 using a 2-look GSD. Data included in the IA-1 would no longer be used for the validation phase.The clinical trial will initially start as a 3-look group sequential design (GSD). Alpha-spending will be calculated using Lan-DeMets spending function (with O'Brien-Fleming parameter). At the first interim analysis (IA-1) the threshold on the ROC curve may be re-computed using the ROC curve generated using the IA-1 data, in which case, the validation trial would start afresh following IA-1 using a 2-look GSD. Data included in the IA-1 would no longer be used for the validation phase.
Masking:
None (Open Label)
Masking Description:
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.
Primary Purpose:
Screening
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
Actual Study Start Date :
Oct 24, 2017
Actual Primary Completion Date :
Jul 23, 2018
Actual Study Completion Date :
Jul 23, 2018

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. 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 [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.

Secondary Outcome Measures

  1. 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 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.

  2. 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 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.

  3. 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.]

    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.

  4. 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.]

    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.

  5. 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.]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center Downey California United States 90242
2 University of Colorado Denver Aurora Colorado United States 80045
3 Medstar Rehabilitation Hospital Washington District of Columbia United States 20010
4 Shirley Ryan AbilityLab Chicago Illinois United States 60611
5 Marionjoy Rehabilitation Hospital Wheaton Illinois United States 60187
6 Kentucky Clinic Lexington Kentucky United States 40536
7 Boston Medical Center Boston Massachusetts United States 02118
8 Henry Ford Health System Detroit Michigan United States 48202
9 New York Presbyterian/Weill Cornell Medical Center New York New York United States 10021
10 New York Presbyterian Hospital/Columbia University Medical Center New York New York United States 10032
11 The Burke Medical Research Institute White Plains New York United States 10605
12 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
13 Helsinki University Central Hospital Helsinki Finland 00029

Sponsors and Collaborators

  • Nestlé
  • Cytel Inc.
  • Regulatory and Clinical Research Institute Inc
  • Nestec Ltd.

Investigators

  • Study Director: Natalia Muhlemann, MD, Nestle Health Science
  • Principal Investigator: Richard Harvey, MD, Shirley Ryan AbilityLab (Rehabilitation Institute of Chicago)

Study Documents (Full-Text)

More Information

Publications

Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT03387267
Other Study ID Numbers:
  • 16.21.CLI
First Posted:
Jan 2, 2018
Last Update Posted:
May 20, 2021
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details The trial was stopped on 23 July 2018 when the announcement of futility stopping was made.
Pre-assignment Detail
Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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.
Period Title: Overall Study
STARTED 452
COMPLETED 438
NOT COMPLETED 14

Baseline Characteristics

Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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 Participants 452
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]
68
Sex: Female, Male (Count of Participants)
Female
166
36.7%
Male
286
63.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
3
0.7%
Asian
20
4.4%
Native Hawaiian or Other Pacific Islander
1
0.2%
Black or African American
78
17.3%
White
331
73.2%
More than one race
17
3.8%
Unknown or Not Reported
2
0.4%

Outcome Measures

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

Outcome Measure Data

Analysis Population Description
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).
Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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.
Measure Participants 242
Number [Probability]
0.64
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-arm Dysphagia Detection System
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter AUC under ROC curve
Estimated Value 0.64
Confidence Interval (1-Sided) 95%
to 0.72
Parameter Dispersion Type:
Value:
Estimation Comments
2. Secondary Outcome
Title AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MILD-Ba
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.
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 Data

Analysis Population Description
Primary analysis for futility was based on 242 subjects (Interim Analysis).
Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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.
Measure Participants 242
Number [Probability]
0.65
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-arm Dysphagia Detection System
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter AUC under ROC curve
Estimated Value 0.65
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments
3. Secondary Outcome
Title AUC Under ROC Curve to Compare the DDS Predicted Swallow Safety Outcome (Binary) vs. Clinical Reference Standard VFS for MOD-Ba
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.
Time Frame The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.

Outcome Measure Data

Analysis Population Description
Primary analysis for futility was based on 242 subjects (Interim Analysis).
Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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.
Measure Participants 242
Number [Probability]
0.576
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Single-arm Dysphagia Detection System
Comments
Type of Statistical Test Other
Comments
Statistical Test of Hypothesis p-Value
Comments
Method
Comments
Method of Estimation Estimation Parameter AUC under ROC curve
Estimated Value 0.576
Confidence Interval (2-Sided) %
to
Parameter Dispersion Type:
Value:
Estimation Comments
4. Secondary Outcome
Title The Sensitivity & Specificity for Swallow Efficiency Using THIN-Ba
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.
Time Frame The study procedure of simultaneous VFSS and DDS measurement using THIN-Ba was completed in one day for each subject.

Outcome Measure Data

Analysis Population Description
The analysis for secondary endpoints were to be carried out in a hierarchical fashion in the specified order, only if primary endpoint was met: swallow safety using MILD-Ba swallow safety using MOD-Ba swallow efficiency using THIN-Ba swallow efficiency using MILD-Ba swallow efficiency using MOD-Ba Outcomes on swallow efficiency were not analyzed.
Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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.
Measure Participants 0
5. Secondary Outcome
Title The Sensitivity & Specificity for Swallow Efficiency Using MILD-Ba
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.
Time Frame The study procedure of simultaneous VFSS and DDS measurement using MILD-Ba was completed in one day for each subject.

Outcome Measure Data

Analysis Population Description
The analysis for secondary endpoints were to be carried out in a hierarchical fashion in the specified order, only if primary endpoint was met: swallow safety using MILD-Ba swallow safety using MOD-Ba swallow efficiency using THIN-Ba swallow efficiency using MILD-Ba swallow efficiency using MOD-Ba Outcomes on swallow efficiency were not analyzed.
Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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.
Measure Participants 0
6. Secondary Outcome
Title The Sensitivity & Specificity for Swallow Efficiency Using MOD-Ba
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.
Time Frame The study procedure of simultaneous VFSS and DDS measurement using MOD-Ba was completed in one day for each subject.

Outcome Measure Data

Analysis Population Description
The analysis for secondary endpoints were to be carried out in a hierarchical fashion in the specified order, only if primary endpoint was met: swallow safety using MILD-Ba swallow safety using MOD-Ba swallow efficiency using THIN-Ba swallow efficiency using MILD-Ba swallow efficiency using MOD-Ba Outcomes on swallow efficiency were not analyzed.
Arm/Group Title Single-arm Dysphagia Detection System
Arm/Group Description 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.
Measure Participants 0

Adverse Events

Time Frame 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.
Adverse Event Reporting Description
Arm/Group Title Dysphagia Detection System (DDS)
Arm/Group Description 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.
All Cause Mortality
Dysphagia Detection System (DDS)
Affected / at Risk (%) # Events
Total 1/438 (0.2%)
Serious Adverse Events
Dysphagia Detection System (DDS)
Affected / at Risk (%) # Events
Total 5/438 (1.1%)
Gastrointestinal disorders
Pharyngo-oesophageal diverticulum 1/438 (0.2%) 1
Nervous system disorders
Haemorrhage intracranial 1/438 (0.2%) 1
Seizure 1/438 (0.2%) 1
Surgical and medical procedures
Gastrostomy 2/438 (0.5%) 2
Other (Not Including Serious) Adverse Events
Dysphagia Detection System (DDS)
Affected / at Risk (%) # Events
Total 0/438 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Kemuel Reyes
Organization Nestlé Health Science
Phone (908) 333-9379
Email Kemuel.Reyes@us.nestle.com
Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT03387267
Other Study ID Numbers:
  • 16.21.CLI
First Posted:
Jan 2, 2018
Last Update Posted:
May 20, 2021
Last Verified:
Jan 1, 2019