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Wearable Monitoring Systems for Swallowing Function and Disorders

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04243577
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Georgia A. Malandraki, Purdue University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Deglutition Disorders Device: Tele-EaT Sensors Device: Conventional Sensors Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Experiments will follow a within-subject randomized cross-over design. The purpose is to develop devices that are optimized for their use. To achieve this goal, for each new iteration of the devices, at least ten new participants will be tested using the current prototypes and the commercially available counterpart sensors in counterbalanced order. Results will be analyzed and discussed in regards to design improvements before the next iteration of development. The plan to recruit a large number of total subjects allows for several pre-clinical experiments to be conducted until the final versions of both devices are optimized.
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : September 10, 2021
Estimated Study Completion Date : September 10, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Experimental Sensors
This arm will include the use of the experimental wearable sensors we are developing.
Device: Tele-EaT Sensors
Several iterations of a wearable surface EMG sensors patch and a wearable intra-oral lingual press device that we will develop, will be tested against commercially available wired devices. The wearable sensor patch will be an ultrathin patch with a honeycomb-inspired design that includes 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 wearable intra-oral device will integrate a wireless intraoral sensor system that will allow simultaneous recording of lingual pressure and movement during swallows and lingual tasks in a wireless fashion. Participants will perform standardized swallow tasks with both devices.

Active Comparator: Conventional Sensors
This arm will include the use of the conventional sensors: regular snap on sEMG electrodes and IOPI device bulb.
Device: Conventional Sensors
Conventional sensors will include snap-on wired electrodes and the use of the Iowa Oral Performance Instrument as the control conditions. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.




Primary Outcome Measures :
  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. Peak pressure during maximum lingual press and swallows (signal quality parameter) [ Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]
    The peak pressure achieved during maximum lingual presses and during swallows will be recorded and compared between the two lingual press devices tested. Peak pressure is used here as a signal quality parameter and not as a health related outcome.

  3. 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 for both the sEMG and the lingual press devices tested. Signal to noise ration is a signal quality parameter and not a health related outcome.


Secondary Outcome Measures :
  1. 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 and intraoral irritations 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 and intraoral cavity 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). 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.

  2. 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 10-item 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 or in my mouth). 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.

  3. Onset of sEMG activity relative to onset of swallow apnea [ Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]
    Time of onset of sEMG activity relative to the time of onset of swallow apnea will be calculated for each task and device. This variable will serve as a timing measure to help us evaluate the temporal sensitivity of the systems.

  4. Time to reach peak pressure [ Time Frame: Post each experiment (i.e., 1 hour after the sensors have been placed) ]
    Time to reach peak pressure will be measured in seconds and is another temporal measure of interest.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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):


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243577


Contacts
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Contact: Georgia Malandraki, PhD 765-496-0207 swallowinglab@purdue.edu
Contact: Georgia A. Malandraki, PhD 765-496-0206 malandraki@purdue.edu

Locations
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United States, Indiana
Purdue University I-EaT Lab Recruiting
West Lafayette, Indiana, United States, 47907
Contact: Barb Brown, MS    765-496-0206    swallowinglab@purdue.edu   
Contact: Georgia A. Malandraki, PhD    7654960206    malandraki@purdue.edu   
Sponsors and Collaborators
Purdue University
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Georgia A. Malandraki, PhD Associate Professor
Principal Investigator: Chi Hwan Lee, PhD Assistant Professor
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Responsible Party: Georgia A. Malandraki, Associate Professor, Department of Speech, Language and Hearing Sciences, Purdue University
ClinicalTrials.gov Identifier: NCT04243577    
Other Study ID Numbers: 1807020788
1R21EB026099-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases