insomnia
Conditions
Interventions
Test group (tACS group):Professional trainers will clean the scalp and position the electrode cap to the corresponding position of the patients prefrontal cortex (Fz, Fp1, Fp2, F7, F8)
Turn on the device and confirm that the electrode impedance < 5 kO
The tACS group was given 2mA, 5Hz frequency alternating current stimulation for 20 min/day, 5 days/week for a total of 2 weeks (10 sessions in total), followed by a 2-week follow-up period
Control group (pseudostimulation group):The pseudo-stimulation group was given very low-intensity stimulation, making it difficult for patients to detect the presence of stimuli, and the rest of the p
Real-time EEG monitoring will also be performed during treatment, and venous blood will be collected before treatment and at the end of 2 weeks of treatment.
Sponsors
Naval Medical Center of PLA
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients aged between 18-75 years old, clinically diagnosed with gastrointestinal tumors with moderate to severe insomnia symptoms, insomnia duration of at least 1 month, expected survival of more than 3 months, clear consciousness and ability to cooperate with treatment and evaluation.
Exclusion criteria
Exclusion criteria: Severe neurological diseases (stroke, epilepsy, Parkinson's disease, etc.); History of psychiatric disorders (depression, anxiety, schizophrenia, etc.); Participating in other clinical trials or treatments that affect sleep at the same time; Severe liver and kidney insufficiency or other vital organ failure; Contraindications to tACS (pacemaker, intracranial metal implantation, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pittsburgh Sleep Quality Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Hamilton Depression Rating Scale (HAMD);electroencephalogram,EEG;Insomnia Severity Index (ISI) score;sleep onset latency (SOL);total sleep time (TST);sleep efficiency;sleep quality;SF-36 health status score;daily interference;numeric rating scale (NRS);Hamilton Anxiety Scale (HAMA); | — |
Countries
China
Contacts
Public ContactHaiyan Yue
Naval Medical Center of PLA
Outcome results
None listed