Active not recruitingOBSERVATIONAL

Predictors Of Cognitive Decline Using Digital Devices

This study aims to discover if individuals experiencing memory difficulties, or healthy volunteers, are willing and able to use certain digital devices, such as smartwatches and sleep headbands. The goal is to collect information from these devices, along with regular health data, to see if it can help predict conditions like dementia much earlier. This research is part of a larger effort to understand how digital technology can be used to spot early signs of memory problems. Participants will be patients from Essex Memory clinics and their family or friends. Your involvement would help researchers understand if these tools are practical and useful for future studies.

At a glance

Status

Active not recruiting

Sponsor

University College, London

Enrolment target

135

Start

19 Jul 2022

Estimated completion

31 Jan 2030

Dementia Mild Cognitive Impairment (MCI)Subjective Cognitive Decline (SCD)Rapid Eye Movement Sleep Behavior Disorder Healthy Control Patients of the Same Age

What is this study about?

This study, called CODEC II, is looking into how digital devices can help us understand and potentially predict memory problems and dementia. Researchers want to see if people who are experiencing mild memory issues, or those who are healthy, are able and willing to use devices like smartwatches and headbands for sleep tracking. They'll also use special apps on smartphones. The main idea is that by collecting lots of information from these devices, alongside your usual health records, we might be able to spot early signs of conditions like dementia long before they become obvious.

This is a 'real-world' study, meaning it's about seeing how these devices work in everyday life. For this study, patients from Essex Memory clinics and their partners or carers will be invited to take part. Researchers are especially interested in whether people find these devices easy to use, whether they remember to wear them, and if the data collected is useful. This information will help them understand if these types of digital tools are good for much larger studies in the future.

Ultimately, this research is part of a bigger project called EDoN (Early Detection of Neurodegenerative Disease). The long-term goal of EDoN is to use a combination of digital information and medical records to create smart computer models. These models could one day help doctors predict someone's risk of developing dementia many years before any symptoms appear. Your participation would be really valuable in helping to make this future vision a reality.

Key takeaways

Study explores digital devices for early detection of memory decline.
Involves smartwatches, sleep headbands, and smartphone apps.
Aims to understand if people with memory issues (or healthy) can use these tools.
Participants can be memory clinic patients or their support network.
Findings will help design future, larger studies.
No new medications are involved in this research.

Who may be eligible?

To join this study, you need to be at least 40 years old. You might be suitable if you are a patient attending an Essex Memory Clinic for concerns about your memory, or if you are a family member, partner, or friend of such a patient and are generally healthy. You need to be able to give your consent in writing and understand English well enough to follow study instructions and use the digital devices.

It's important that you have a smartphone that runs Android version 7.0 or newer, or iPhone (iOS) version 12.2 or newer. If your phone isn't compatible, the study might be able to provide you with one, as long as you're happy to use it as your main phone. You also need to be comfortable using a smartphone and the provided digital devices, either on your own or with help from a partner or carer, and have internet access at home for your smartphone.

However, some people won't be able to join. This includes if you have a serious mental health condition that needs regular specialist care (like schizophrenia or bipolar disorder). You also can't take part if you are receiving end-of-life care, or if you've had an allergic reaction to latex or rubber in the past. If you have been diagnosed with dementia, a carer or family member must also be willing to help you with using the devices.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 40 years old or older?
Do you have a compatible smartphone (Android 7.0+ / iOS 12.2+)?
Are you able to use a smartphone and other digital devices (perhaps with help)?
Do you have internet access at home for your smartphone?
Can you provide written consent and understand study information in English?
Do you not have a serious mental health condition requiring specialist care (e.g., schizophrenia)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be involved for up to five years, though the intensive digital data collection happens mostly in the first year. You'll have some initial visits to share your health history, and then you'll be given some digital devices to use at home. These will include a smartwatch, a headband to track your sleep, and two smartphone apps. You'll need to wear these devices regularly and use the apps. The researchers will be collecting data from these devices at different times over the first year (at the start, and then at 3, 6, 9, and 12 months). Clinical information will also be collected at the start and followed up for up to 5 years. You won't be given any new medications as part of this study, as it's about observing how you use technology. If you don't have home WiFi, you can still participate but won't use the sleep headband.

Potential risks and benefits

Taking part in this study could help researchers understand more about how digital devices can assist in the early detection of memory problems, which could benefit many people in the future. It's important to remember that this is a research study, and there are no guaranteed direct benefits to you personally. Potential risks are generally low, mainly related to using the digital devices themselves, such as skin irritation from wearing a device, or the minor inconvenience of remembering to charge and wear them. You might also need to undergo some additional health assessments if your existing records don't include them. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

St Margarets Hospital
Verified postcode
Epping, United Kingdom

Common questions

What kind of devices will I need to use?

You'll be asked to use a smartwatch, a headband that tracks sleep, and two special apps on your smartphone.

How long will I be involved in the study?

The study collects information at the start and then for up to five years. Digital device information is mainly collected in the first 12 months.

Do I need my own smartphone?

Yes, you need a compatible smartphone (Android 7.0+/iOS 12.2+). If yours isn't compatible, the study may provide one if you're willing to use it.

Will I have to take new medicine?

No, this study does not involve taking any new medications. It's about using digital technology.

What if I don't have home WiFi?

You can still join the study, but you won't be asked to use the sleep tracking headband.