Skip to main content
OpenTrials
Completed

NCT Number: NCT04243577

Wearable Monitoring Systems for Swallowing Function and Disorders

Wearable tele-rehabilitation technology allows for the efficient provision of rehabilitation services from a distance, facilitating tele-management of many disorders. The proposed research will develop and validate a set of mechanically compliant, easy-to-use, and inexpensive wearable tele-monitoring systems, for future use in the rehabilitation of swallowing disorders (dysphagia). The hypothesis is that the newly developed wearable sensors will have equal or better performance than traditional wired sensors used today in clinical practice. Factors related to signal quality and patient reported outcomes (e.g., satisfaction/comfort level, adverse effects etc.) will be examined.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Purdue University I-EaT Lab

West Lafayette, Indiana, 47907, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for healthy adults:

  • Age 18-30 OR 50-90 years of age
  • No history of dysphagia
  • No history of a neurological disorder
  • A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA):
  • A score of <3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Inclusion criteria

for patients with dysphagia:

  • Age 18-90 years of age
  • Diagnoses of dysphagia as a result of a neurological disorder (e.g., stroke, Parkinson's disease).
  • A score in the normal/mild range on the Montreal Cognitive Assessment (MoCA).
  • A score of ≥3 on the Eating Assessment Tool-10 (EAT-10, a self-report screening for dysphagia).

Exclusion criteria

  • Significant cognitive impairment (a score in the moderate-severe range on MoCA):

Treatment and study plan

Tele-EaT Sensors

Device

Two iterations of a wearable surface EMG (sEMG) sensors patch we developed will be tested against commercially available wired devices. The first iteration of the wearable sensor patch is an ultrathin patch with a honeycomb-inspired design that included sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. The second iteration is a more durable slightly thicker flexible, non-stretchable, and double-sided thin sEMG patch. Participants will perform standardized swallow tasks while wearing the device.

Conventional Sensors

Device

Conventional sensors will include snap-on wired electrodes as the control condition. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.

Primary outcomes

  1. Normalized Task-related sEMG Amplitude (Signal Quality Parameter)

    Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)

    Normalized sEMG amplitude values during standardized swallow tasks and maneuvers will be recorded and compared between the two sEMG devices. Normalized amplitude is used as a signal quality parameter and is not a health related outcome.

  2. Signal to Noise Ratio (Signal Quality Parameter)

    Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)

    Signal to Noise ratio will be calculated and compared between sensor types tested. Signal to noise ration is a signal quality parameter and not a health related outcome.

Secondary outcomes

  1. Ease of Use/Comfort

    Time frame: Post each experiment (i.e., 1 hour after the sensors have been placed)

    Ease-of-use/comfort will be examined using a survey also devised by the investigators (using a positive centered 5-point Likert scale) with questions about ease-of-use/comfort after each experiment with each device. This survey includes statements related to the participants' ease-of-use/comfort during the experimental protocol (e.g., I was comfortable while the experimenter placed the sensors on my skin). The answers will be rated on a 10-point scale (i.e., 1 = extremely uncomfortable, 10 = extremely comfortable). Higher values indicate better or higher satisfaction/comfort scores. Total scores will be compared across conditions/devices tested.

    For the first iteration testing, the scale used for this outcome measure included 5 survey questions rated on a 10-point scale (total possible: 50; range 0-50). For the second iteration testing, we added one more question, hence the scale included 6 survey questions (total possible: 60; range: 0-60).

  2. Adverse Effects and Safety

    Time frame: Pre and Post each experiment (i.e., right before the placement of sensors on the subject and 1 hour after the sensors have been placed and 5 minutes after their removal)

    Safety will be examined by documenting the incidence of skin irritations and pain in the subjects. A visual inspection form including a binary scale (YES/NO) has been devised by the investigators (no formal name) and will be used by a rater who will thoroughly inspect the participants' submandibular skin before and after each experiment. For any irritation or change in appearance YES will be selected and the type of irritation will be descriptively recorded (e.g., red skin). Pain is also rated in the same way through a question to the participants. This form will be completed by a rater who is not part of the data collection process and who is blinded to sensors type to avoid any bias.The number of YESs will be used to calculate the incidence of these adverse effects in the sample.

Sponsors and collaborators

Lead sponsor

Purdue University

Other

Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Registry information

Official study title

Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jan 28, 2020
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.