Early Phase 1
Completed N=70
Wearable Monitoring Systems for Swallowing Function and Disorders
Deglutition Disorders
Source: ClinicalTrials.gov NCT04243577 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcomePrimary: Normalized Task-related sEMG Amplitude (Signal Quality Parameter) — 12.5; 11.7; 17.3; 13.8 percentage of maximum amplitude — p=<0.025
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.
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 | — |
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. Informational only — not medical advice.