English

How can wearable biometric data describe health events as tipping points and help predict them?

The timing of health events - such as births, migraines, or epilepsy - remains one of the great uncertainties in health science. Gaining a deeper understanding of when these events are likely to occur could open the door to timely interventions, potentially reducing their impact or even preventing them altogether. These events can often be understood through the lens of tipping points: thresholds where small changes trigger abrupt shifts in a system's behavior. While tipping points are widely recognized in fields like climate science, they are also relevant in biology, ecology, economics, and health science.

The human body, as a complex dynamical system, is influenced by numerous interacting components and its environment. Health events, such as the onset of migraines or epileptic seizures, can be seen as tipping points where cascading processes within the body lead to critical outcomes. Research has shown that early warning signals, such as reduced ability to recover, increased variability, and heightened correlation between system components, can be detected in observational data, offering a way to anticipate these events. For instance, non-invasive devices like wrist-worn biometric sensors have demonstrated potential in predicting health events by capturing meaningful physiological data.

By exploring tipping points and their early warning signals, we can unlock new opportunities for predicting and preventing health events such as spontaneous labor, migraines, and seizures. This understanding could revolutionize healthcare by enabling the development of robust, scalable technologies for proactive intervention.

For participants

We are now recruiting participants for the study Forecasting Migraine!

About the study

In this study, we will examine whether a smartwatch can detect changes in the body before you notice that a migraine attack is about to begin. We aim to find out whether data collected by the watch may help predict migraine attacks and how participants experience using the watch and apps over time.

Who can participate?

You can participate if you:

• have episodic migraine, with or without aura, and typically experience at least two migraine attacks per month
• have not changed your preventive migraine medication during the past two months. You may also take part if you do not use preventive medication
• are aged 18 or older
• live in Tromsø or the surrounding area
• understand written Norwegian well enough to sign written informed consent

Unfortunately, you cannot take part if you experience more than three migraine attacks per week, receive Botox treatment for migraine, or are currently being assessed to start or change your preventive treatment.

We aim to recruit up to 20 participants for the study.

What do we require from participants?

The study will last for approximately six months. You should live your life as usual during the study period, and participation will not affect your migraine treatment.

During the study, you will be asked to:

• 1) Wear a smartwatch. You will be provided with a watch for the duration of the study. To ensure that we collect the best possible data, we ask you to wear it day and night, removing it only when it needs to be charged. The watch measures physical activity, heart rate, skin temperature and sweat on the wrist.
• 2) Record your migraine episodes in an app. You will record information including your symptoms, the severity of the episode and any medication you have taken. If relevant, we will also ask you to record your menstrual periods so that we can investigate possible links between migraine attacks and hormonal changes.
• 3) Complete a short questionnaire at baseline. The questionnaire includes questions about your age, medication and any other health conditions. It takes less than five minutes to complete.

You will need to install two apps on your phone: one that transfers data from the watch and one that you will use to record migraine attacks. You will receive information and help to get started.

Optional additional activities

Some participants will be invited to:

• wear an additional smartwatch for approximately four weeks and install an app linked to this watch
• take part in a focus group interview about your experience of using the watches and apps, and what you would expect from a possible warning or forecast

Participation in these additional activities is optional. You can still participate in the study if you do not wish to use an additional watch or take part in an interview.

What is “in it” for you?

In this study, you will not be given information about upcoming migraine attacks during the study, but you will receive a summary of your own results once the project has ended. The results from this study can contribute to the development of solutions that could eventually make it possible to provide advance warning of migraine attacks.

What will happen to your information?

Your information will be processed in accordance with applicable data protection regulations and research ethics requirements. It will be stored without your name, national identity number or other information that directly identifies you. You will not be identifiable when the study results are published.

Some measurements will be transferred through systems operated by the watch manufacturer, Empatica, before being stored at UiT The Arctic University of Norway. This includes transfers to servers in the U.S. Empatica will not be told who you are, that you have migraine or why you are taking part in the study.

You may also choose whether anonymised data can be made available for future research. This is entirely optional and will not affect your opportunity to participate in the study.

You will find more information about how we process your information in the participant information and consent form (only in Norwegian): [Link to the participant information sheet]

Participation is voluntary

Participating is voluntary. Before deciding whether to participate, you will receive detailed information and have the opportunity to ask questions. If you decide to participate, you will be asked to sign a consent form.

You may withdraw from the study at any time without giving a reason. This will have no negative consequences for you or for the treatment and follow-up care you receive. If you withdraw, your information will no longer be used for research. You may also request access to the information stored about you, ask for incorrect information to be corrected and request that your information be deleted, provided that it has not already been anonymised or published.

The project team

The study is being conducted by UiT The Arctic University of Norway, which is responsible for the project. The study is led by Erlend Hoftun Farbu at the Department of Community Medicine.

Please get in touch if you would like more information or are interested in participating in the study:

Project e-mail:
fotip@helsefak.uit.no

Project leader: Erlend Hoftun Farbu
E-mail: erlend.h.farbu@uit.no
Telephone: +47 77 64 55 23