Clinical trial NCT04243577: Wearable Monitoring Systems for Swallowing Function and Disorders
Official title: Development and Validation of Mechanically Compliant Wearable Monitoring Systems for Swallowing Function and Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Deglutition Disorders
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
First posted: 2020-01-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: OTHER

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.


Eligibility 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):

Primary outcomes:
measure: Normalized Task-related sEMG Amplitude (Signal Quality Parameter)
timeFrame: Post each experiment (i.e., 1 hour after the sensors have been placed)
measure: Signal to Noise Ratio (Signal Quality Parameter)
timeFrame: Post each experiment (i.e., 1 hour after the sensors have been placed)
Secondary outcomes:
measure: Ease of Use/Comfort
timeFrame: Post each experiment (i.e., 1 hour after the sensors have been placed)
measure: Adverse Effects and Safety
timeFrame: 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)
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University I-EaT Lab
state: Indiana
Study officials:
affiliation: Professor
name: Georgia A. Malandraki, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Chi Hwan Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References: