| Field |
Value |
| NCT ID |
NCT04664634 |
| Status |
Recruiting |
| Phase |
Phase 3 |
| Sponsor |
Northwestern University |
| Enrollment |
60 participants |
| Start Date |
September 2023 |
| Completion Date |
December 2025 |
This randomized, controlled Phase 3 trial evaluates a novel digital therapeutic platform designed to treat dysphagia (swallowing difficulties) and sialorrhea (excessive drooling) in Parkinson's Disease patients. The platform combines sensor-based monitoring with targeted exercises.
The digital therapeutic platform utilizes:
- Biofeedback-assisted swallowing exercises: Real-time visualization of swallowing mechanics
- Sialorrhea management modules: Behavioral modification through cueing and reminder systems
- Progress tracking: Continuous monitoring of symptom severity and treatment response
- Age 50-85 years
- Diagnosed with Parkinson's Disease
- Clinically significant dysphagia or sialorrhea
- Stable PD medication regimen
- Access to smartphone/tablet
- Severe cognitive impairment (MMSE < 20)
- Recent stroke or neurological event
- Structural esophageal disease
- Active dental issues affecting drooling
- Change in Swallowing Quality of Life (Swal-QoL) score
- Change in Drooling Severity and Frequency Scale (DSFS)
- Timed swallowing tests
- Patient satisfaction ratings
- Caregiver burden assessments
Dysphagia and sialorrhea are debilitating non-motor symptoms affecting up to 50% of PD patients. This digital therapeutic approach offers a non-pharmacological, accessible treatment option that can be used at home.
- ClinicalTrials.gov: NCT04664634