To evaluate the clinical efficacy and safety of neuromodulation by transcranial direct current stimulation (tDCS) in the patients with primary chronic insomnia .
* visit 1 * to fill in a questionnaire (Clinical Global Impression, CGI; Leeds Sleep Evaluation Questionnaire, LSEQ; Stanford Sleepiness Scale, SSS; Hospital Anxiety and Depression Scale, HADS; 36-Item Short Form Survey, SF-36) * EEG * visit 2-6 * tDCS stimulation (monday \~ friday) * anodal / cathodal / sham * to fill in a questionnaire (CGI, LSEQ, SSS, HADS) * analysis the results of sleep log and actigraphy * visit 7 : 1 week after treatment * to fill in a questionnaire (CGI, LSEQ, SSS, HADS) * analysis the results of sleep log and actigraphy * EEG * visit 8 : 1 month after treatment * to fill in a questionnaire (CGI, LSEQ, SSS, HADS, SF-36) * analysis the results of sleep log
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
8
Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
Seoul National University Hospital
Seoul, South Korea
sleep log and actiwatch
Changes of sleep quality
Time frame: Change from baseline at 1 week
questionnaire
Time frame: Change from baseline at 1 month
EEG spectrum analysis
Time frame: Change from baseline at 1 month
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Change from baseline at 1 month
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