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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Richard Walker
+44 (0)191 2932709
Richard.Walker@nhct.nhs.uk


More information about this study, what is involved and how to take part can be found on the study website.

Study Location:

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Be Part of Research - Trial Details - A wearable device for people with Parkinson’s disease to help with drooling and other symptoms of Parkinson’s

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

Not Recruiting

Open to: All Genders

Age: Adult

Medical Conditions

Parkinson's disease


This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Drooling is a common symptom of Parkinson’s disease, experienced in up to 70% of people with Parkinson’s (PwP). Drooling can be a major problem in PwP due to decreased automatic swallowing, particularly when people are multi-tasking and concentrating on other things such as watching television. When automatic swallows don’t occur, saliva pools in the mouth leading to drooling which can be very embarrassing and restricts the social life of PwP. Current treatments decrease the production of saliva, which need to be repeated on a 3-monthly basis. Such treatments are problematic as saliva is essential for good oral health. Impaired reduction of loss of saliva through drooling exposes individuals to a range of negative health and psychosocial issues. NICE therefore recommend non-invasive treatment options such as behavioural cueing methods. A wearable wrist device using haptic (touch based) cueing was not only an effective treatment method to increase swallowing but also a socially acceptable solution for PwP. However, the device had limited functionality and was not suitable for all day use for example, participants were required to wear it for 1 hour per day and had to manually start/stop the cueing as needed; this made it less desirable as an everyday solution. Further work is needed in a larger sample size and to understand the real-world behaviours and usage of the intervention to understand the longer-term effects. We will deploy an application (App) on a smartwatch designed to work with a smartphone. The smartwatch is a discrete and comfortable wearing device that can be worn on the wrist – referred to as Cue Band. We will recruit 3000 PwP to wear the device throughout our 6-week evaluation. Participants will be asked to wear the device 24/7 during this time, giving us a greater understanding of the effectiveness and acceptability of the technology within real-world use. We will explore the application of CUE Band to deliver haptic cueing in an interventional study for 300 PwP experiencing drooling.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

28 Mar 2022 31 Oct 2023

Publications

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

Participants are being asked to take part in an eight-week cueing method intervention study. This will involve being asked to take part in two different methods that will provide cueing (a vibration) for swallowing. Participants are being asked to wear a discrete and comfortable device that can be worn on the wrist, referred to as Cue Band and use a Smartphone app, only. We would like participants to take part in the cueing methods for 6-weeks, 24 hourly. To do so, they will be asked to download an Apps on their smartphone device that will allow them to access the software used for the cueing methods. Once downloaded, they will be randomly allocated to receive either the Cue Band method for cueing or the Smartphone method for Cueing. Participants will complete the first cueing method for the first 3-weeks, followed by a two-week wash out period where no intervention will be received, following this the participant will receive the alternative cueing method for the following 3-weeks. The Cue Band will be posted out to participants for free and will be theirs to keep.

Following the 8-week intervention, participants will be asked to stop using the cueing methods for a period of 3-weeks prior to further assessment. This part of the study is optional and participants can carry on using their preferred cueing method if they would prefer to.

Once participants have finished the intervention, they can set up their preferred prompting method for example, the Cue Band or Smartphone only, or they can disable and remove the mobile applications if they no longer wish to use them.

As part of the assessments, participants will be asked to complete questionnaires and maintain a daily diary. Some of the participants will be invited to take part in a semi-structured interview.


Any person living with Parkinson's disease who self-identifies as having an issue with drooling.

You can take part if:



You may not be able to take part if:


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


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • North Tyneside General Hospital
    Northumbria Healthcare NHS Foundation Trust Rake Lane
    Tyne & Wear
    NE29 8NH
  • North Cumbria Integrated Care NHS Foundation Trust
    Newtown Rd
    Carlisle
    CA2 7HY

There are no perceived risks of participating, however, we envisage possible benefits of the study include the use of the device as a cueing method for swallowing.

Prof Richard Walker
+44 (0)191 2932709
Richard.Walker@nhct.nhs.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by Northumbria Healthcare NHS Foundation Trust and funded by Parkinson's UK.





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Read full details for Trial ID: ISRCTN59284050

Or CPMS 51528

Last updated 04 June 2024

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