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

A wearable device for cueing for the management of drooling, and monitoring of symptoms, in people with Parkinson’s disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59284050

Enrollment

3300

Registered

2022-05-04

Start date

2022-03-28

Completion date

Unknown

Last updated

2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease Nervous System Diseases

Interventions

The first phase of the project involves developing 3000 wearable devices that will be published in a mobile app using iOS and Android. As part of this phase of the project, we have received ethical ap

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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). 2. Acceptability of the device for use in day to day life (daily dairies and interviews). 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.	—

Measure

Time frame

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). 2. Acceptability of the device for use in day to day life (daily dairies and interviews). 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.

—

Countries

England, Northern Ireland, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026