A wearable device for people with Parkinson’s disease to help with drooling and other symptoms of Parkinson’s

Not Applicable

Completed

• Conditions: Parkinson's disease; Nervous System Diseases

• Registration Number: ISRCTN59284050
• Lead Sponsor: orthumbria Healthcare NHS Foundation Trust

Brief Summary

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36827274/ (added 02/10/2023)

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-04
• Study Completion: 2024-01-01
• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 3300

Inclusion Criteria

1. PwP experiencing symptoms of oropharyngeal dysphagia or self-reporting as having difficulties with drooling and swallowing.
2. PwP that own an iOS or Android smartphone device (to support the research engagement). Their smartphone must support Bluetooth BLE 4.0+ to communicate with the band (relatively standard in smartphones for 4-5 years).
3. PwP willing and able to provide consent to participate.

Exclusion Criteria

Participants with insufficient cognitive function and manual dexterity with/without assistance from carers.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Drooling frequency and severity measured using the ROMP-Saliva scale at baseline (pre-intervention) and following the first cueing method and second cueing method.

Secondary Outcome Measures

Name	Time	Method
1. Frequency, severity, and duration of drooling on the visual analogue scales, UPDRS 2.2 subset for saliva, NMSQ and PDQ-8 (measured daily in the app).<br>2. Acceptability of the device for use in day to day life (daily dairies and interviews).<br><br>Participants will be asked to maintain a daily diary using the tools provided through our mobile app. They will self-report on their swallowing severity, frequency and duration using visual analogue scales, placing a cross on a 100-millimetre (mm) line, (0 mm being no problem) and (100 mm being as bad as can be); as well as provide any additional comments or reflections on their experiences that day. Prior to receiving the interventions, participants will complete a two-week baseline during our on boarding phase, whereby they complete the daily diary (drooling severity chart) and self-reporting without any intervention.