RecruitingNot ApplicableInterventional

Assessment of the effect of transcranial direct current stimulation on insomnia in primary care patients

This study is exploring a new treatment for insomnia, which is trouble falling or staying asleep. Insomnia makes life difficult and can affect your health. Current treatments like therapy can be expensive or have long waiting lists, and medicines can have side effects. Researchers are investigating if a device called Flow Neuroscience FL-100, which uses a very gentle electrical current to the head (tDCS), can help. This treatment is safe for home use and has few, mild side effects. If successful, it could offer a new, affordable way for millions of people in the UK to improve their sleep and overall well-being. The study wants to find out if tDCS can really reduce insomnia for people seen by their GP.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

General Practice Alliance

Enrolment target

100

Start

15 Aug 2025

Estimated completion

23 Mar 2027

Insomnia

What is this study about?

Many people struggle to fall asleep or stay asleep, a common problem called insomnia. This can be really upsetting and impact both your mind and body. While there are some treatments available, like talking therapies, they can be costly or have long waits. Sleeping pills can also have side effects or become something you rely on.

Because of these challenges, doctors are looking for new, effective, and easy-to-use ways to help people with insomnia. This study is focusing on a special treatment called transcranial direct current stimulation, or tDCS for short. It involves a device that sends very gentle electrical currents through two small pads placed on your forehead. Think of it like a very mild, safe electrical nudge to your brain.

This isn't a new technology; tDCS has been used safely for other health conditions. Recent research suggests it might also help with sleep. By exploring if a tDCS device, like the Flow Neuroscience FL-100, can reduce insomnia, this study aims to find out if this could become a widely available treatment through the NHS. Imagine being able to improve your sleep with a simple, at-home device – it could make a huge difference to many lives.

Key takeaways

This study investigates a home-based device for insomnia using gentle electrical currents.
It aims to find a new, affordable treatment option for people with sleep difficulties.
The treatment involves using a handheld device with a smartphone app for 30 minutes, five times a week, for four weeks.
Common side effects are mild, like skin tingling or redness, and usually disappear quickly.
You must be an adult with insomnia symptoms and a smartphone to participate.
Participation includes completing questionnaires and potentially an optional interview.

Who may be eligible?

To join this study, you need to be an adult aged 18 or older and currently experiencing symptoms of insomnia, meaning you have trouble falling or staying asleep. You also need to be able to understand the study information and give your written permission to take part. It's also important that you have a smartphone with internet access and a data plan, as the treatment uses an app.

There are some reasons why you wouldn't be able to join. For example, if you have epilepsy or a history of seizures, or if you have any metal or electrical devices implanted in your body, like a pacemaker or a cochlear implant. You also can't take part if you have a hole in your skull, a brain condition, or a history of certain mood conditions (like hypomania/mania). If you have an open wound on your forehead where the pads would go, or if you are pregnant, you also wouldn't be able to participate.

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 18 years old or older?
Do you currently have trouble falling or staying asleep (insomnia)?
Do you have a smartphone with internet access?
Do you *not* have epilepsy or a history of seizures?
Do you *not* have any implanted medical devices like a pacemaker or cochlear implant?
Are you *not* pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first read all the study details and sign a consent form. Before starting and after finishing the treatment, you'll complete five quick health questionnaires, which are like 'tick box' forms.

The main part of the study involves using a device called Flow Neuroscience FL-100 at home. You'll download a free app to your mobile phone, connect the device to your phone using Bluetooth, and then start the stimulation. You'll use the device for 30 minutes, five times a week, for a total of four weeks. You'll also fill out a questionnaire about your experience using the device and share your feedback. There’s an optional part where you might be asked to take part in an interview over the phone or computer video, lasting less than an hour, to talk about your experience with insomnia and the treatment. This interview would be recorded.

Potential risks and benefits

A potential benefit of joining this study is that the tDCS treatment may help improve your insomnia symptoms and sleep quality. This type of gentle electrical stimulation has been studied for over 40 years, and the devices used are designed to limit the current to a very low, safe level. The most common minor side effects, experienced by some people, include mild skin redness where the pads are placed (which goes away), itching, tingling, a temporary headache, discomfort, or a warm feeling – these also usually disappear after use. While discussing insomnia in the optional interview might be uncomfortable for some, you always have the right to withdraw from the study at any time without giving a reason.

Locations (1)

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

General Practice Alliance (GPA)
City only
Northampton, England

Common questions

What is tDCS?

tDCS stands for transcranial direct current stimulation. It's a non-invasive treatment that uses a very gentle electrical current applied to your head through pads to stimulate specific parts of the brain.

Do I have to go to a clinic for treatment?

No, this study uses a device that you can use at home. You'll control it with an app on your smartphone.

What if I feel uncomfortable during the study?

You are free to stop participating in the study at any time, for any reason, without it affecting your medical care.

How long will I be using the device?

You'll use the device for 30 minutes, five times a week, for a total of four weeks.

Is this treatment available to everyone?

This is a research study to see if tDCS is an effective treatment for insomnia. If successful, it could potentially become an NHS treatment in the future.

How to find out more

Chris Griffiths

chris.griffiths@nhft.nhs.uk +44 (0)1604685518 Official trial record

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