Not yet recruitingOBSERVATIONAL

AI-PROGNOSIS - Digital Biomarkers Development Study (dBM-DEV)

The AI-PROGNOSIS study, called dBM-DEV, is exploring if smartwatches can help detect early signs of Parkinson's disease. Researchers are particularly interested in a sleep problem called REM sleep behaviour disorder (RBD), which can be an early indicator of conditions like Parkinson's. Currently, diagnosing RBD requires a complex sleep study in hospital. This study aims to find a simpler way to detect RBD using data collected passively from smartwatches worn at home. They'll compare smartwatch data from people with RBD, healthy volunteers, and people already diagnosed with Parkinson's. The goal is to develop an easy-to-use tool for checking for these important sleep changes.

At a glance

Status

Not yet recruiting

Sponsor

University Hospital, Toulouse

Enrolment target

Start

20 Sep 2024

Estimated completion

15 Jul 2025

Parkinson Disease

What is this study about?

This study, called AI-PROGNOSIS dBM-DEV, is looking into how smartwatches might help us understand and potentially spot early signs of Parkinson's disease. Parkinson's is a condition that affects the brain and can cause problems with movement. Before movement issues start, some people experience a sleep problem called REM sleep behaviour disorder, or RBD. People with RBD act out their dreams, which can be a key early sign of conditions like Parkinson's.

Right now, the only way to officially diagnose RBD is through a special overnight sleep test in a hospital, which can be a bit of a hassle. The main idea behind this study is to see if smartwatches, which many people wear every day, can collect enough information to detect RBD reliably and easily. If successful, this could offer a much simpler way to check for this important sleep change, potentially helping people get help sooner.

The study will involve two main groups. First, a 'development' group including people with confirmed RBD and healthy volunteers will help the researchers work out what smartwatch data is important. Then, a 'confirmation' group of people with Parkinson's disease will also wear smartwatches. By comparing data from all these groups, the researchers hope to build a reliable way to spot early signs of brain conditions using everyday technology.

Key takeaways

Aims to use smartwatches to detect early signs of Parkinson's disease.
Focuses on a sleep problem called REM sleep behaviour disorder (RBD).
Hopes to offer an easier way to check for RBD than current hospital tests.
Involves wearing a smartwatch and using an app for 4 weeks or 3 months.
Open to people with RBD, healthy volunteers, and people with Parkinson's.
You can withdraw from the study at any time.

Who may be eligible?

The study is looking for different groups of people. For the first part, called the 'development' group, they need people who have already been diagnosed with a sleep problem called REM sleep behaviour disorder (RBD) through a special sleep test. These people also need to have someone they share a bedroom with at night and be able to use a smartphone with the study's app. They also need healthy volunteers who are similar in age and sex to the people with RBD and can use the app, but who don't have RBD.

For the second part, called the 'confirmation' group, they are looking for people who have already been diagnosed with Parkinson's disease. These individuals should not have memory problems (dementia) and, like the other groups, need to be able to use a smartphone with the study's app and have someone they share a bedroom with. They will also need to score within a certain range on a questionnaire about sleep.

Generally, if you can't give your consent (permission) to take part, or if the research team feels you're not motivated enough for the study tasks, you won't be able to join. Also, you need to have a social security number to participate. The study is open to anyone aged 18 or over, regardless of their sex.

Quick self-check

Are you 18 or over?
Do you have a diagnosis of REM sleep behaviour disorder (RBD) confirmed by a sleep test, OR are you a healthy volunteer similar in age and sex to someone with RBD without a history of RBD?
OR do you have a confirmed diagnosis of Parkinson's disease and do not have dementia?
Can you use a smartphone reliably with a study app?
Do you share your bedroom at night with a care partner?
Do you have a social security number?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join the study, what you do depends on which group you're in. All participants will have a starting visit where doctors will check your health and you'll fill out some questionnaires. After this, you'll wear a smartwatch as you go about your daily life.

If you're in the 'development' group (people with RBD or healthy volunteers), you'll wear the smartwatch for about 4 weeks. If you're in the 'confirmation' group (people with Parkinson's disease), you'll wear the smartwatch for about 3 months. People in the Parkinson's group will also have the special overnight sleep test (polysomnography) to see if they have RBD. You'll need to use a smartphone that works with the study's app throughout your participation.

Potential risks and benefits

Participating in research studies like this helps doctors learn more about diseases and develop better ways to detect them. A potential benefit of this study is contributing to the development of a simpler way to spot early signs of Parkinson's disease, which could help many people in the future. As for risks, wearing a smartwatch and using a smartphone app generally carries very low risk. However, there might be minimal discomfort from wearing the watch or minor technical issues. You will be monitored by the study team, and you always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Neurology Toulouse Hospital
Toulouse, France
Klinik und Poliklinik für Neurologie of University Hospital (Regulatory autorization pending)
Dresden, Germany
Hospital Ruber Internacional
Madrid, Spain
King's college of London (Regulatory authorization pending)
London, United Kingdom

Common questions

What is REM sleep behaviour disorder (RBD)?

RBD is a sleep problem where you physically act out your dreams during REM sleep, often shouting or moving a lot. This is different from normal dreams where your body is usually still.

Why are smartwatches being used?

Smartwatches can track things like movement and heart rate throughout the day and night. Researchers hope this data can help them identify patterns linked to RBD without needing complex hospital tests.

Will I get my test results from the study?

The study aims to collect information for research. Specific results from your individual tests might not be shared with you immediately, but you can always ask the study team about their policy on this.

Do I need my own smartphone?

Yes, you need to have a smartphone that works with the study's app and be able to use it. This is how the smartwatch will connect and send data.

What if I don't want to continue with the study?

You are free to leave the study at any time, for any reason. Your decision will not affect your medical care.

How to find out more

Nadege ALGANS

algans.n@chu-toulouse.fr 33-561777204 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.