Early Phase 1
N=70
Wearable Monitoring Systems for Swallowing Function and Disorders
Deglutition Disorders
Bottom Line
View on ClinicalTrials.gov: NCT04243577 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Normalized Task-related sEMG Amplitude (Signal Quality Parameter) — 12.5; 11.7; 17.3; 13.8 percentage of maximum amplitude — p=<0.025
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Tele-EaT Sensors (Device); Conventional Sensors (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Purdue University
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalized Task-related sEMG Amplitude (Signal Quality Parameter) |
12.5; 11.7; 17.3; 13.8 | <0.025 sig |
| PRIMARY Signal to Noise Ratio (Signal Quality Parameter) |
19.5; 20.4; 25.1; 26.7 | <0.025 sig |
| SECONDARY Ease of Use/Comfort |
48.06; 48.62; 54; 57 | <0.05 sig |
| SECONDARY Adverse Effects and Safety |
8; 1; 12; 4 | — |
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):
Data sourced from ClinicalTrials.gov (NCT04243577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.