Chronic insomnia is clinically characterized by difficulty falling asleep, difficulty maintaining sleep or early morning awakening, reduced sleep quality, and a total sleep duration of less than 6.5 hours. These symptoms occur at least three times per week and are accompanied by daytime functional impairments. The resulting daytime dysfunction mainly includes fatigue, low mood or irritability, som
Conditions
Interventions
Test group (Group A):High-Voltage Therapy
Control group(Group B):Sham High-Voltage Therapy
Sponsors
The Seventh Affiliated Hospital Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
25 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 25 to 65 years with mild to moderate insomnia, with a disease duration of 3 months to 10 years; 2. Subjects who meet the diagnostic criteria for chronic insomnia based on the International Classification of Sleep Disorders, Third Edition (ICSD-3), characterized by difficulty initiating sleep, maintaining sleep, or early morning awakening, accompanied by daytime functional impairment, with a duration of >=3 months; 3. Insomnia severity categorized as mild to moderate (Insomnia Severity Index [ISI] score between 8 and 21; Pittsburgh Sleep Quality Index [PSQI] score between 6 and 15); 4. Ability to maintain sitting or lying position for more than 40 minutes; 5. No history of uncontrolled severe physical illness or active psychiatric disorders. Subjects with stable and well-controlled chronic diseases (e.g., under long-term medication) may be included if their condition does not interfere with adherence to the study protocol or the safety of the intervention, and if insomnia is not the primary manifestation—subject to investigator assessment; 6. Capable of undergoing and tolerating EEG and fNIRS assessments; 7. Voluntarily signs the written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Individuals who do not meet the above diagnostic or inclusion criteria; 2. Presence of active or uncontrolled psychiatric disorders, including but not limited to major depressive disorder, bipolar disorder, and schizophrenia. Subjects with mild to moderate, stable, and well-controlled mood disorders may be considered if insomnia is not the primary cause and inclusion criteria are met; 3. Diagnosed with other primary sleep disorders, such as obstructive sleep apnea syndrome or restless legs syndrome; 4. Presence of acute or progressive neurological conditions, such as Parkinson’s disease, epilepsy, or recent stroke; 5. History of receiving brain stimulation therapies (e.g., transcranial magnetic stimulation [TMS], transcranial direct current stimulation [tDCS]) within a recent period; 6. Uncontrolled severe cardiovascular or metabolic diseases, including uncontrolled hypertension, diabetes, thyroid dysfunction, etc.; 7. Presence of active severe complications or organic diseases such as severe infections, liver or kidney dysfunction, tumors, etc.; 8. Women who are menstruating, trying to conceive, pregnant, or breastfeeding; 9. Known hypersensitivity or intolerance to electrical stimulation; 10. Family history of hereditary sleep disorders; 11. Poor compliance or inability to complete study visits and follow-up assessments; 12. Individuals whose data are incomplete or whose conditions are deemed by the investigator to interfere with the evaluation of efficacy or safety; 13. Presence of implanted medical devices such as pacemakers, cardiac stents, or other metallic implants; 14. Subjects who have already initiated similar intervention protocols more than one week prior to enrollment, or are receiving unstable pharmacologic treatment that may affect sleep assessment. (Stable medications not affecting sleep evaluation may be continued, but must be documented.);
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index (PSQI);Electroencephalogram (EEG); | — |
Secondary
| Measure | Time frame |
|---|---|
| Functional Near-Infrared Spectroscopy (fNIRS);Self-Rating Depression Scale (SDS);Insomnia Severity Index (ISI);Self-Rating Anxiety Scale (SAS); | — |
Countries
China
Contacts
Public ContactMao Yurong
The Seventh Affiliated Hospital Sun Yat-sen University
Outcome results
None listed