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The RCT study of personalized closed-loop transcranial electrical stimulation for insomnia

The RCT study of personalized closed-loop transcranial electrical stimulation for insomnia

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110917
Enrollment
Unknown
Registered
2025-10-22
Start date
2025-09-08
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Sleep disorder

Interventions

Intervetion group:tDCS

Sponsors

Zhongshan Hopital,Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Agree to sign the informed consent form; 2. Commit to comply with the study procedures and cooperate with the entire research process; 3. Aged between 18 and 75 years; 4. Diagnosed with chronic insomnia (according to DSM-5 criteria); 5. Have the ability to take care of oneself and no history of substance abuse; 6. Have not received ECT, rTMS, tES treatment, or cognitive-behavioral therapy for insomnia within 8 weeks prior to enrollment; 7. If the patient is taking sedative-hypnotic medications, there must be no changes in drug type or dosage within 8 weeks prior to enrollment.

Exclusion criteria

Exclusion criteria: 1. Pregnant women with impaired or failing critical organ functions such as the heart, lungs, liver, or kidneys, or with unstable vital signs; 2. Organic lesions in the brain or other parts of the body; 3. History of migraine, with >=4 migraine attacks per month for two consecutive months; 4. Hearing impairment, tinnitus, or visual damage; 5. Patients with severe obstructive sleep apnea syndrome; 6. Severe depressive mood (HAMD-17 score >17).

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index;

Secondary

MeasureTime frame
Degree of sleep improvement;Changes in sleep, psychological, and cognitive functions;

Countries

China

Contacts

Public ContactDing Jing

Zhongshan Hopital,Fudan University

ding.jing@zs-hospital.sh.cn+86 135 0191 7091

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026