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Contact Information:

Dr Chris Griffiths
chris.griffiths@nhft.nhs.uk


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Be Part of Research - Trial Details - Assessment of the effect of transcranial direct current stimulation on insomnia in primary care patients
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Assessment of the effect of transcranial direct current stimulation on insomnia in primary care patients

Recruiting

Open to: All Genders

Age: Mixed

Northampton

Medical Conditions

Insomnia

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Insomnia (difficulties falling or staying asleep) is a common, distressing, and impairing sleep disorder and is linked to poor mental and physical health. Clinical guidelines recommend cognitive behavioural therapy for insomnia (CBT-I) (which can be effective for some people, but is costly and there can be long wait times) and medication (which has negative side effects and creates dependency). Therefore, an alternative effective, acceptable and affordable treatment is required to relieve insomnia. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation (NIBS) which delivers low-voltage electric currents applied through two pads on the forehead. tDCS is safe to use at home and has rare and minor side effects (for example, tingling sensation, mild skin irritation or redness, short headache or dizziness). It is currently used for treating mental health conditions. Recent studies suggested that tDCS could also improve sleep quality and reduce insomnia. Evidence about the improvement with tDCS could expand NHS treatment for millions of people who experience insomnia. Having a new effective treatment in the NHS that can be used at home could be life-changing for people with insomnia.
Aim: To investigate if insomnia is reduced in primary care participants who receive tDCS

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

15 Aug 2025 23 Mar 2027

Participants will be recruited from primary care practices. They are required to read the participant information sheet (PIS) and sign a consent form. At the start and end of treatment, participants will complete five ‘tick box’ health assessments. Optionally, participants may take part in an interview via phone or computer video, with a duration of less than one hour.

Participants will read the information given about the device and use the device as per protocol: 30 minutes, 5 times a week for 4 weeks. They will complete a participant usage questionnaire and provide feedback. Participants may also be contacted by Northamptonshire Healthcare NHS Foundation Trust project researchers for optional verbal feedback via an audio-recorded interview. Using Flow entails downloading a free app to a mobile phone, connecting the headset to the phone via Bluetooth, opening the app, and starting stimulation by pressing a button titled: START STIMULATION.


Patients aged from 18 to 110 years reporting insomnia symptoms.

You can take part if:



You may not be able to take part if:


1. Epilepsy (or having a history of seizures)2. Having a defect in the neurocranium and/or a cranial implant3. Having an active, implanted medical device (e.g., cardiac pacemaker, spinal cord stimulator, vagal nerve stimulator, auricular stimulator, deep-brain-stimulating electrodes, cochlear implant, implanted hearing aid or defibrillator) or other implanted, metallic, or electronic device4. A neurological condition5. A history of hypomanic/manic episodes6. Do not have the capacity to consent7. Open wound in the area of pad contact on the forehead8. Pregnant


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • General Practice Alliance (GPA)
    3 Adelaide Street
    Northampton
    NN2 6AL

Possible benefits: Evidence shows that tDCS can treat symptoms of insomnia.
Possible risks: tDCS has been used in humans for over 40 years. These stimulation techniques use battery-powered current generator devices that have a built-in circuitry to limit the current above a certain level, typically 2 mA, which is a very low level of current. The most common sensations/side effects are only experienced by some people and include: mild skin redness (54%) at the site of the electrodes, which resolves following stimulation, itching (39%), and tingling (22%), temporary headache (16%), discomfort (13%) and heating sensation (10%), which resolve following use. In the optional interview, participants may or may not find discussing issues related to insomnia uncomfortable or distressing.

Dr Chris Griffiths
chris.griffiths@nhft.nhs.uk



The study is sponsored by General Practice Alliance and funded by National Institute for Health and Care Research.



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Read full details for Trial ID: ISRCTN99671371
Last updated 01 June 2026

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