Not yet recruitingNAINTERVENTIONAL

Wearable-Based Study of Depression and Sleep in Older Adults

This 4-year research project in Taiwan is exploring new and better ways to help older adults (aged 60 and over) who are experiencing depression and sleep difficulties. The study will first check how well a wrist-worn device works to track sleep and activity. Later on, it will test a special headband that uses gentle light therapy to see if it can improve depression and sleep. The aim is to create a more effective management plan for depression in later life. This research also helps build a unique database of information about older adults, combining device data with health records to find new ways to understand and treat depression.

At a glance

Status

Not yet recruiting

Phase

Sponsor

China Medical University Hospital

Enrolment target

162

Start

01 Mar 2026

Estimated completion

31 Dec 2029

Elderly Depression Sleep Disturbance

What is this study about?

This study is particularly important because, like many places, Taiwan is seeing a growing number of older people, and many of them struggle with depression and sleep issues. Currently, doctors often rely on questionnaires to understand how someone is feeling, but these only show a snapshot and might miss daily changes. This makes it harder for healthcare professionals to spot and treat late-life depression effectively.

That's where wearable devices come in. The researchers believe these devices could offer a more objective and continuous way to track how someone is doing. For instance, a watch-like device can track sleep patterns and activity levels. This study wants to see how well these devices work and if a special light therapy headband can actually help improve both mood and sleep for older adults with depression. The light therapy uses a gentle, near-infrared light to encourage brain activity in a positive way.

Ultimately, this project hopes to create a new, technology-assisted approach to managing depression in older adults. By gathering lots of information from these devices, along with regular health checks, the researchers aim to build a strong database. This will help them identify 'digital fingerprints' of depression and find early warning signs, leading to more personalised and effective care in the future for mental well-being in later life.

Key takeaways

Targets older adults (60+) with depression and sleep problems.
Uses wearable devices to track mood and sleep more objectively.
Tests a light therapy headband to see if it can improve symptoms.
Aims to create new, technology-assisted ways to manage depression.
May help develop more personalised care for mental health in later life.
Participation involves wearing devices and attending assessments.

Who may be eligible?

To be considered for this study, you would need to be 60 years old or older. You must also have met the criteria for major depression, which your doctor would confirm using specific guidelines. Your depression would also need to be at a certain level of severity, as measured by a standard questionnaire.

It's important to know that you might still be able to join if you're taking medicines for your mood, sleep, or body clock, as long as your dose has been stable for at least two weeks before the study starts. You'd also need to agree to take part, or if you couldn't, your main caregiver could give permission for you.

However, some conditions would mean you couldn't take part. These include having dementia, bipolar disorder, psychosis, or active thoughts of harming yourself in the last three months. You also couldn't join if you have certain acute infections, like a cold or COVID-19, or some skin conditions on your head that might affect the light therapy, such as tattoos or open wounds in those areas.

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 60 years old or older?
Have you been diagnosed with major depression by a doctor?
Are you able to use a wearable device, or does your caregiver support you?
Do you *not* have certain other conditions like dementia or active suicidal thoughts?
Do you *not* have significant skin conditions or tattoos on your head that would affect light therapy?
Have your current medications for mood or sleep been stable for at least 2 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last for a total of four years, though your individual involvement will be shorter and happen in different stages. In the first stage, you would wear a special watch-like device on your wrist for at least four weeks. This device tracks your activity and sleep, and the researchers will compare its information with how you answer questions about your sleep and mood.

Later on, if you're part of the main trial, you would be randomly assigned to use either a special light therapy headband or a 'dummy' headband that looks the same but doesn't deliver the light therapy. This is done so neither you nor the researchers know who is getting the active treatment, which helps make the results more reliable. You would use this device at home for daily sessions while continuing any regular treatments you already receive. There will also be regular check-ups and assessments throughout your participation to see how you are doing, including reviewing your mood, sleep, and possibly collecting some biological samples. The total duration of your active participation would depend on the specific phase you join.

Potential risks and benefits

Taking part in this study could potentially help you feel better, as the light therapy device might improve your depression and sleep symptoms, although this is not guaranteed as it is a research study. Your involvement will also provide valuable information that could lead to better ways to help older adults with depression in the future. As with any study, there could be some minor risks, such as mild skin irritation from the wearable devices, though these are generally considered safe. You might also find the regular assessments and device use requires a time commitment. It's very important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

China Medical University Beigang Hospital
Verified postcode
London, United Kingdom

Common questions

What kind of wearable devices will I be using?

Initially, you'll wear a wrist-worn device that tracks your activity and sleep. Later, if you're part of the trial, you'll use a special headband that delivers light therapy, or a similar-looking headband without the therapy.

Will I still continue with my usual depression treatment?

Yes, you will continue with any regular treatments you are already receiving for your depression and other health conditions while participating in this study.

How long will I need to be in the study?

The study itself lasts four years, but your individual participation will be shorter. For example, wearing the wrist device for at least four weeks, and then potentially participating in the headband trial for a set period.

What is 'photobiomodulation'?

Photobiomodulation (PBM) is a fancy name for light therapy. It uses gentle, near-infrared light from a device, like a headband, to try and improve brain activity, which could help with mood and sleep.

What if I feel unwell during the study?

You should always report any concerns or changes in your health to the study team immediately. You can also withdraw from the study at any time if you wish.

How to find out more

Dr Ta-Wei Guu Consultant psychiatrist, MD, PhD

066753@tool.caaumed.org.tw +886-57837901 Official trial record

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