Study Rationale: Trouble with swallowing and increased drooling are common issues for people with Parkinson’s disease (PD). These oral symptoms occur in up to 80% of cases. Our prior work showed that an advanced wearable sensor, which vibrates silently and is worn on the upper chest of people with PD, can both accurately monitor swallowing and increase swallowing frequency in individuals experiencing oral dysfunction.
Hypothesis: We hypothesize that a digital therapeutic platform centered on our wearable sensor, coupled with oversight from a speech-language pathologist, will increase swallowing frequency in people with PD in the home setting. Increasing swallow frequency should ultimately improve oral functioning, reduce drooling, and reduce the risk of aspiration.
Study Design: We will begin by modifying and improving our system to facilitate future regulatory approval. We will strengthen our existing algorithm to include more individuals with PD. Finally, we will conduct a randomized controlled trial to demonstrate that this digital therapeutic platform with our wearable sensor will increase swallow frequency in people with PD at home, and improve swallowing and drooling in reports provided by these individuals.
Impact on Diagnosis/Treatment of Parkinson’s disease: Because swallowing and drooling problems are so common in PD, we believe this digital therapeutic platform will serve as a future standard of care and an essential technology for speech-language pathologists worldwide who care for people with PD.
Next Steps for Development: This study will enable us to submit our digital therapeutic platform for regulatory clearance, which will be an important first step to make the sensor available to individuals with PD and to speech-language pathologists. Future efforts will include validating other clinical benefits and measurements relevant to people with PD.