A protocol for the evaluation of a wearable device for monitoring of symptoms, and cueing for the management of drooling, in people with Parkinson's disease

Abstract

Drooling is a common symptom of Parkinson's Disease (PD) experienced in up to 70% of people with PD (PwP). Drooling can be a major problem in PwP leading to adverse physical and psychosocial issues. Current medical treatments decrease the production of saliva, whereas the problem is due to decreased swallowing frequency, not over production of saliva. Such treatments are problematic as saliva is essential for good oral health. Therefore, non-invasive treatments options such as behavioural cueing methods are recommended. A wrist-worn device delivering haptic cueing has been demonstrated to be an effective treatment method to increase swallowing frequency and a socially acceptable solution for PwP. However, the device had limited functionality and was tested on a small sample size over a short period of usage. Further work is required to understand the real-world behaviours and usage of the intervention to understand the longer-term effects with a larger sample size. This research will deploy CueBand, a discrete and comfortable wrist-worn device designed to work with a smartphone application to support the real-world evaluation of haptic cueing for the management of drooling. We will recruit 3,000 PwP to wear the device day and night for the intervention period to gain a greater understanding of the effectiveness and acceptability of the technology within real-world use. Additionally, 300 PwP who self-identity as having an issue with drooling will be recruited into an intervention study to evaluate the effectiveness of the wrist-worn CueBand to deliver haptic cueing (3-weeks) compared with smartphone cueing methods (3-weeks). PwP will use our smartphone application to self-assess their drooling frequency, severity, and duration using visual analogue scales and through the completion of daily diaries. Semi-structured interviews to gain feedback about utility of CueBand will be conducted following participants completion of the intervention.

Fig 1. Schedule of enrolment, interventions, and assessments.

Fig 2. Overview of the cueing study recruitment and design; including a breakdown of the study activities.

NB for the cueing study we will also recruit from patients under the care of the Northumbria Healthcare NHS Foundation Trust (NHCFT) Parkinson’s Service.