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NCT04243577 · ClinicalTrials.gov registry record · Early Phase 1
Wearable Monitoring Systems for Swallowing Function and Disorders
A Early Phase 1 study, sponsored by Purdue University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 70
- Enrollment target
NCT04243577: Completed Early Phase 1 study, sponsored by Purdue University.
NCT04243577 is a Early Phase 1 study that has completed, run by Purdue University. The registered enrollment target is 70 participants, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04243577, a Early Phase 1 study, has completed, sponsored by Purdue University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 70 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE Tele-EaT Sensors
- DEVICE Conventional Sensors
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2018-09-11 |
| Est. Completion | 2023-07-25 |
| Phase | Early Phase 1 |
What the finished NCT04243577 record still lists
NCT04243577 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (32% higher).
The record links to 0 conditions, and to 2 interventions - of which Tele-EaT Sensors is the first listed.
NCT04243577 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04243577 about?
NCT04243577 is a clinical study titled "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-monitorin...
What is the current status of trial NCT04243577?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2018-09-11. Estimated completion is 2023-07-25.
What interventions are being tested in trial NCT04243577?
The interventions under investigation include: Tele-EaT Sensors (DEVICE), Conventional Sensors (DEVICE).
Who is sponsoring clinical trial NCT04243577?
This trial is sponsored by Purdue University, which has 141 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04243577's enrollment target sits among peer trials
70 339th of 2000 higher than 1,647 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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