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Neck-Worn swallow detector fails key test

NCT ID NCT03387267

Diagnosis Sponsor: Société des Produits Nestlé (SPN) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a wearable device that sits on the neck to detect swallowing problems in people with conditions like stroke, Parkinson's, multiple sclerosis, Alzheimer's, or dementia. The device was compared to a standard X-ray test. Unfortunately, the device did not meet the accuracy goals, and the study was stopped early.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Dysphagia Detection System (a wearable device with a sensor placed on the neck)
What this could lead to
If it had worked, this device could have offered a simple, non-invasive way to screen for swallowing problems at the bedside, reducing the need for X-ray tests.
What could go wrong
The trial was stopped early because the device did not perform well enough (accuracy was below the threshold set by researchers). This means the device is not ready for use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

452 people

The number who actually took part.

Started

Oct 2017

Finished

Jul 2018

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease Deglutition Disorders dementia multiple sclerosis Parkinson disease stroke disorder traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Dementia Multiple sclerosis Oropharyngeal dysphagia Parkinson disease Stroke

Contacts and locations

Locations

  • Boston Medical Center

    Boston, Massachusetts, 02118, United States

  • Helsinki University Central Hospital

    Helsinki, 00029, Finland

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Kentucky Clinic

    Lexington, Kentucky, 40536, United States

  • Marionjoy Rehabilitation Hospital

    Wheaton, Illinois, 60187, United States

  • Medstar Rehabilitation Hospital

    Washington D.C., District of Columbia, 20010, United States

  • New York Presbyterian Hospital/Columbia University Medical Center

    New York, New York, 10032, United States

  • New York Presbyterian/Weill Cornell Medical Center

    New York, New York, 10021, United States

  • Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center

    Downey, California, 90242, United States

  • Shirley Ryan AbilityLab

    Chicago, Illinois, 60611, United States

  • The Burke Medical Research Institute

    White Plains, New York, 10605, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • University of Colorado Denver

    Aurora, Colorado, 80045, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.