Transcranial current stimulation to help insomnia
The Effects of Transcranial Current Stimulation on Insomnia
NA · The First Hospital of Jilin University · NCT07340268
This trial tests whether mild electrical stimulation of the scalp can help adults with psychophysiological insomnia sleep better and normalize brain activity.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The First Hospital of Jilin University (other) |
| Locations | 2 sites (Ch’ang-ch’un, Jilin and 1 other locations) |
| Trial ID | NCT07340268 on ClinicalTrials.gov |
What this trial studies
Adults diagnosed with insomnia disorder will receive either active transcranial current stimulation or a sham (placebo) stimulation protocol, with investigators comparing sleep-related symptoms and brain measures between groups. The protocol includes neurophysiological assessments and brain imaging to detect structural and functional changes related to sleep. Participants complete questionnaires and undergo MRI as part of outcome measurement, while those with other sleep disorders, mental illness, recent CNS-active medication use, or MRI contraindications are excluded. The goal is to link any clinical sleep improvements with underlying neurobiological changes.
Who should consider this trial
Good fit: Adults with a clinical diagnosis of insomnia disorder who can complete questionnaires and meet exclusion criteria (no other sleep disorders, no major mental illness, and no recent CNS-active medication or substance use) are ideal candidates.
Not a fit: People with other primary sleep disorders, organic brain lesions, ongoing use of conflicting medications, significant alcohol use, or shift work are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could provide a noninvasive treatment option that improves sleep quality and alters sleep-related brain activity in people with insomnia.
How similar studies have performed: Prior small studies of transcranial current stimulation for sleep problems have shown mixed but sometimes promising effects, so the approach has preliminary support but is not yet confirmed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinical diagnosis of insomnia disorder * Cooperate to complete the questionnaire surveys Exclusion Criteria: * Presence of mental disorders * Current use of central nervous system stimulants * Use of analgesics,sedatives or hypnotic medications, theophylline preparations, steroid medications * Alcohol abuse or regular alcohol consumption * Diagnosis of other sleep disorders, including obstructive sleep apnea, rapid eye movement sleep behavior disorder, or restless legs syndrome * Sleep disorders secondary to organic diseases, such as epilepsy, diabetes, or renal failure * Shift work or irregular work schedules that disrupt normal circadian rhythms * Use of medications affecting central nervous system function within the past one month * Recent sleep-related confounding behaviors within the past two weeks, including staying up late, alcohol consumption, or smoking * Presence of organic brain lesions on head MRI and contraindications to MRI examination
Where this trial is running
Ch’ang-ch’un, Jilin and 1 other locations
- the First Hospital of Jilin University — Ch’ang-ch’un, Jilin, China (COMPLETED)
- the First Hospital of Jilin University — Ch’ang-ch’un, Jilin, China (RECRUITING)
Study contacts
- Study coordinator: Zan Wang, MD, PhD
- Email: wangzan@jlu.edu.cn
- Phone: +86 88782678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Insomnia, Psychophysiological