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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN99671371

Enrollment

100

Registered

2025-08-14

Start date

2025-08-15

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insomnia Mental and Behavioural Disorders

Interventions

Design The study has an open-label patient cohort design with no control group. Patients complete pre- and post-intervention self-report measures. In-depth interviews will be undertaken with patients

Eligibility

Sex/Gender

All

Age

18 Years to 110 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 years and over 2. Patients reporting insomnia symptoms 3. Able to provide written informed consent 4. Have a smart mobile phone with internet access and a data download contract

Exclusion criteria

Exclusion criteria: 1. Epilepsy (or having a history of seizures) 2. Having a defect in the neurocranium and/or a cranial implant 3. 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 device 4. A neurological condition 5. A history of hypomanic/manic episodes 6. Do not have the capacity to consent 7. Open wound in the area of pad contact on the forehead 8. Pregnant

Design outcomes

Primary

Measure	Time frame
The severity and impact of insomnia symptoms will be measured using the self-reported Insomnia Severity Index (ISI) pre- and post-intervention	—

Secondary

Measure	Time frame
The following secondary outcome measures will be self-reported pre- and post-intervention: 1. Severity of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) 2. Cognitive dysfunction, particularly in the context of depression, will be measured using the Perceived Deficits Questionnaire (PDQ-5) 3. Health-related quality of life will be measured using the EuroQol Group Quality of Life measure (EQ-5D-5L) 4. Daily functioning will be measured using the Work and Social Adjustment (WASA)	—

Measure

Time frame

The following secondary outcome measures will be self-reported pre- and post-intervention: 1. Severity of depression will be measured using the Patient Health Questionnaire-9 (PHQ-9) 2. Cognitive dysfunction, particularly in the context of depression, will be measured using the Perceived Deficits Questionnaire (PDQ-5) 3. Health-related quality of life will be measured using the EuroQol Group Quality of Life measure (EQ-5D-5L) 4. Daily functioning will be measured using the Work and Social Adjustment (WASA)

—

Countries

England, United Kingdom

Contacts

Public ContactChris Griffiths

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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026